Manager, Statistical Programming Resume Samples

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Experience Experience

Chicago, IL

Manager, Statistical Programming

Chicago, IL

Schroeder and Sons

Chicago, IL

Manager, Statistical Programming

Project management activities for identified projects including financial, resource planning and utilization, timelines and milestone management
Provide statistical programming representation on project teams. 10% of Time
Provide validation and review services for internal and external projects. Write up and communicate findings, as necessary. 30% of Time
Provide training on statistical programming related topics
Statistical Programming lead for large global or other major programs
Maintain a positive approach, building a motivating and professional team environment
Contribute to review and amendment of departmental processes and supporting documentation

Dallas, TX

Manager Statistical Programming Western

Dallas, TX

Lang, Bergstrom and Lynch

Dallas, TX

Manager Statistical Programming Western

Provide expert review of process and methodology development work with regard to SP standards and validation procedures
Provide advanced technical expertise for internal and external clients
Maintain knowledge and awareness of developments in statistical programming
May participate as high level lead Stat Programmer on major project(s)
Independently bring project solutions to SP teams and the Statistical Programming department
Serve as a Stat Programming consultant for other members of the department and staff members from other Biostatistics departments within the company
Participate in project meetings; keep up-to-date on project issues; keep Director informed of project issues

present

San Francisco, CA

Senior Manager, Statistical Programming

San Francisco, CA

Wintheiser LLC

present

San Francisco, CA

Senior Manager, Statistical Programming

present

Provide statistical programming input into other disciplines’ activities and participate in interdepartmental processes
Display a positive attitude at all times, promoting and contributing to a good team spirit with a productive and professional environment
Facilitate the flow of information, comment and feedback between senior management and all levels of staff
Assume line management responsibility for a team, conducting performance reviews, setting and regularly reviewing objectives and developing and regularly reviewing training and development plans
Encourage an open and communicative two-way interaction with line reports
Act as Statistical Programming Project Manager or Project Director for large global or other major programs which may include global responsibilities
Provide ongoing supervision, advice and consultation to the Lead Programmers and the rest of the programming team to ensure timely and efficient completion of projects. Ensure all issues raised are addressed and all potential issues are handled proactively

Education Education

Bachelor’s Degree in Biostatistics

University of Illinois at Chicago

Bachelor’s Degree in Biostatistics

Skills Skills

Experience demonstrating a strong attention to detail
Proficiency in SAS/BASE, STAT, GRAPHICS and MACRO.Proficiency in SAS/BASE, STAT, GRAPHICS and MACRO
Experience demonstrating leadership ability and ability to work on a multi-disciplinary project team
Ability to effectively organize and manage multiple staff and assignments
Ability to proactively plan so as to minimize potential re-work, as well as effectively and efficiently problem solve
Strong communication skills both oral and written
Demonstrate leadership and problem solving capability
Knowledge of clinical trials
Working familiarity with clinical trial design and analysis activities and knowledge of regulatory guidelines and industry standards (FDA/CFR, ICH/GCP, CDISC SDTM and ADaM)
Experience in managing and developing staff and their career objectives including the ability to motivate and inspire staff

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Manager, Statistical Programming Resume Examples & Samples

8+ years of experience and a BS degree in Biostatistics/Computer Science or equivalent, or
4+ years of experience and a MS degree in Biostatistics/Computer Science or equivalent, or
2+ years of experience and a PhD degree in Biostatistics/Computer Sciences or equivalent

Senior Manager Statistical Programming Resume Examples & Samples

Designs and develops programs in support of highly complex clinical research analysis and reporting activities
Performs comprehensive review of, and provides input into, project requirements and/or project documentation
Collaborates effectively within statistical programming and with cross-functional working group team members and functional counterparts, including internal and external members
Bachelor’s degree or higher and/or equivalent in computer science, mathematics, or other scientific field (or equivalent theoretical/technical depth)
At least 10 years programming experience with increasing responsibility, preferably in a pharmaceutical/clinical trial environment
Excellent Programming Skills and Programming Specifications knowledge
Experience working on cross functional teams is an asset
Two years project management experience is a preferred
Demonstrated written and verbal communications skills
Extensive and varied experience in planning programming activities and leading teams of programmers
Expert in Source Database Requirements and Documentation
Proven experience in Programming Team Management

Manager, Statistical Programming Sdtm Resume Examples & Samples

Ensures that the local Statistical Programming department meets timelines, provides high quality deliverables, complies with contractual project requirements, and conducts projects within budget
Assigns programmers to projects in a manner which keeps associates at their utilization goal and which matches associates to projects appropriate to their skills, training and experience, while also providing opportunities to work with varied projects, sponsors, and teams
Responsible for staff development to facilitate succession planning and maintaining a programming staff with diverse skills, abilities, and competencies meeting the business needs of Statistical Programming
Sets challenging, achievable goals for associates which contribute to department objectives; supports efforts to achieve those goals. Provides motivating, timely performance feedback to associates on a routine basis as well as for formal performance appraisals

Manager, Statistical Programming Resume Examples & Samples

Attend multi-disciplinary team meetings, representing the programming function
Create or review and approve programming plans at study and project level
Provide input on key study-related documents produced by other functions (e.g. CRFs, Data Management Plan, SAPs, etc.)
Create or review and approve CDISC-compliant datasets and corresponding documentation for electronic submission to regulatory agencies
Develop software systems to generate displays of clinical study data as tables, listings, and graphs for electronic submission to regulatory agencies
Assist statisticians by suggesting algorithms to address novel analysis requests
Develop software validation procedures and test plans, as necessary
Create and document archives of software, outputs, and analysis files
Create and maintain department SOPs related to clinical programming
Review draft clinical reports, journal articles, slide presentations, and other documents to assure that results are reported accurately
Oversee work of internal contract programmers and external vendors
Provide time and resource estimates for project planning

Manager Statistical Programming Resume Examples & Samples

Develop an expertise within a therapeutic area or standard tool. Work with minimal supervision to perform, coordinate and oversee the preparation, execution, reporting and documentation of a project
Function as a lead programmer in the development and QC of tables, listings, graphs, or systems in support of analysis requirements utilizing Regeneron tools and methodologies and current industry standards (i.e. CDISC SDTM / ADaM)
Manage the effort, including esubmssion deliverables, using appropriate tools to track, allocate and summarize extent of work required, progress and completion of programming deliverables. Provide programming support for complex presentations and more complex statistical ad-hoc requests
Act as programming representative in a multidisciplinary study team to ensure timely and quality support for analysis and reporting of clinical trials up to regulatory approval, product launch and annual reports. If applicable, lead an application development and act as the programming representative to the user audience
Work with management to determine resource requirements for therapeutic area or department function responsibilities
Review and select resumes, screen and interview candidates for contractor and permanent positions
Provide feedback to management regarding team member’s contributions to the work effort for evaluating individual's performance and recommend yearly goals
Advises all direct reports about the procedures surrounding retention of data, records, and information for employees in their group
Works independently, exercises judgment in interpreting, modifying, and adapting procedures, practices, methods, etc. in accordance with existing policies and standards for application to specific problems or tasks
Advanced SAS programming skills, preferably in a clinical data environment
Experience in the analysis of at least one therapeutic area
Strong understanding of relational databases and experience working with complex data systems
Strong understanding of reporting systems utilizing multiple data delivery applications
Collaborative teamwork and interpersonal skills that demonstrate initiative and motivation. Ability to problem solve. Excellent verbal and written communication skills in a global environment
Experience in pharmaceutical clinical development in at least one therapeutic area (i.e. understanding of statistical concepts, techniques and clinical trial principles within a therapeutic area) and ability to provide programming support needs for BLA and other regulatory submissions
Experience in project management with minimum supervision. Demonstrates ability to effectively organize and manage multiple assignments with challenging timelines across multiple personnel
Experience in project start-up through submission
Experience in the hiring, development, evaluation and support of junior staff and contractors
Knowledge in creation of current CDISC data structures
SAS, (Base, Stat, Macro, graph) and S-Plus/R
May report to a Assoc. Director or above. Requires the ability to influence others to achieve results. May manage subordinates

Manager, Statistical Programming Resume Examples & Samples

Meet client and business needs to have all projects optimally resourced with suitably
Ensure direct reports meet departmental and project productivity and quality metrics by
Excellent interpersonal, verbal and written communication skills (including experience in

Senior Manager, Statistical Programming Resume Examples & Samples

Manage and oversee departmental activities including appropriate resourcing of staff, staff
May serve as GMBA for a location or country
May manage employees from multiple disciplines (e.g., in smaller countries) and act as role
Revise, implement and monitor departmental compliance with SOPs
Implement process improvements, in conjunction with Management team and the Quality
Proficiency in SAS
Knowledge of the programming and reporting process
Knowledge of WSOPs/Guidelines/System Life Cycle methodologies, ICH-GCP and any other applicable local and international regulations such as 21 CFR Part 11 and proven practical application
Demonstrated application of CRS concepts to achieve best practice and promote continuous improvement
Demonstrate ability to learn new systems and function in an evolving technical environment
Ability to successfully work together with a (“virtual”) team (including international teams as required) as well as independently
Demonstrate strong organizational skills, ability to manage competing priorities, and be flexible to change
Tenacity to work in an innovative environment
Ability to negotiate and influence in order to achieve results
Business/Operational skills that include customer focus, commitment to quality management and problem solving
Good business awareness/business development skills (including financial awareness)
Ability to create, maintain and define strategies to improve the efficiency of running a clinical trial
Work effectively in a quality-focused environment
Demonstrate commitment to refine quality processes
Show commitment to and perform consistently high quality work
Minimum 15 Years of relevant experience
Relevant Clinical Trial industry experience
Project leadership experience required

Manager, Statistical Programming Resume Examples & Samples

Demonstrated experience in managing 10+ team members for at least 2+years
Prior extensive hands on SAS experience is a must for this role
Demonstrated hands-on prior experience in Statistical Programming (TLF/SDTM/ADAM) for clinical trails
Good communication & Project management skills
Background in Engineering/Mathematics/Statistics Preferred
Demonstrated ability to manage and motivate direct reports
Ability to manage Managers
Excellent interpersonal, verbal and written communication skills (including experience in making presentations at conferences, meetings, training sessions)
Outstanding negotiation and organizational skills
A flexible attitude with respect to work assignments and new learning

Manager, Statistical Programming Resume Examples & Samples

Line management of staff including: performance management, and training need identification. Recommends courses of action on salary administration, transfers, new hires, terminations, and professional development. Regularly communicates with staff on working practices, policies, and work instructions
Prioritizes activities across Statistical Programming projects and facilitates mutually beneficial resolutions to project conflicts between groups or individuals which promotes teamwork and quickly restores department effectivenes
Assists programmers in solving technical problems with effective, cost-efficient resolutions
Assists and supports Statistical Programming business development efforts by contributing to requests for information and requests for proposal, and participates at bid defense meetings as requested

Manager Statistical Programming Resume Examples & Samples

Technical responsibilities
In-depth knowledge of applicable clinical research regulatory requirements; i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines
Excellent written and oral communication skills with good interpersonal skills
Very good problem solving skills
Ability to effectively motivate other staff members
Ability to negotiate project deliverable timelines with client
Strong ability to communicate problems/issues along with experience of developing action plans or alternatives for resolution
Master's degree in computer science or related field and 5 years relevant experience including 1 year in a leadership capacity; Bachelor's degree or educational equivalent in computer science or related field and 7 years relevant experience including 1 year in a leadership capacity; or equivalent combination of education, training and experience

Manager, Statistical Programming Resume Examples & Samples

Provide statistical programming support for multiple clinical projects or therapeutic areas
Accountable for providing Statistical Programming support for clinical trials
Collaborates primarily with other statistical programmers, statisticians, and data managers, as well as with clinical teams, to achieve study and project goals
Provide all performance management activities for 0-5 statistical programmers
MS in Statistics, Computer Science or a related field with 8+ years of relevant experience OR BS in Statistics, Computer Science or a related field with 10+ years of relevant experience
High degree of technical competence and communication ability, both oral and written. Competent in SAS programming and Macro development
Pharmaceutical experience with clinical trials, including familiarity with expectations of regulatory agencies, especially FDA and EMEA. NDA/BLA or other regulatory filing experience, including ISS or ISE experience
Thorough understanding of ICH Guidelines and relevant regulatory requirements
Project lead experience required. Management experience not required

Manager, Statistical Programming Resume Examples & Samples

5 years of programming and clinical research or related experience
Or the equivalent combination of education, training, and experience that provides the individual with the required knowledge, skills and abilities
Ability to adapt and adjust to changing priorities
Must be proficient in at least one programming language and have strong technical skills
Demonstrated leadership skills and ability to manage projects and people
LI-KF1

Manager, Statistical Programming Resume Examples & Samples

Ensures that the local SDTM Statistical Programming team meets timelines, provides high quality deliverables,complies with contractual project requirements, and conducts projects within budget
Assigns SDTM programmers to projects in a manner which keeps associates at their utilization goal and which matches associates to projects appropriate to their skills, training and experience, while also providing opportunities to work with varied projects, sponsors, and teams
Performs other work-related duties as assigned. Minimal travel may be required (up to 25%)
BS, MS, or equivalent in Mathematics, Statistics, Computer Science, or related field
Extensive experience in SDTM programming in a clinical trial setting or an equivalent combination of education and experience
Excellent written and verbal communication skills. Demonstrated managerial leadership ability. Ability to read, write, speak, and understand English

Senior Manager, Statistical Programming Resume Examples & Samples

Supervision of less-experienced of statistical programmers within project activities
Provide statistical programming input into other disciplines’ activities and participate in interdepartmental processes
Ensure appropriate review of deliverables, implementing follow-up activities at the individual or departmental level
Demonstrate excellent problem solving skills, a proactive approach and the ability to make sound decisions on a regular basis and communicate these clearly
Display a positive attitude at all times, promoting and contributing to a good team spirit with a productive and professional environment
Facilitate the flow of information, comment and feedback between senior management and all levels of staff
Assume line management responsibility for a team, conducting performance reviews, setting and regularly reviewing objectives and developing and regularly reviewing training and development plans
Encourage an open and communicative two-way interaction with line reports
Provide training and development of less experienced staff within the department
Act as Statistical Programming Project Manager or Project Director for large global or other major programs which may include global responsibilities
Provide ongoing supervision, advice and consultation to the Lead Programmers and the rest of the programming team to ensure timely and efficient completion of projects. Ensure all issues raised are addressed and all potential issues are handled proactively
Provide training on Statistical Programming related topics to other disciplines
Ensure good communication across the global management team
Advise on the Technical planning of projects
Identify and assist others in identifying changes in scope of projects and provide time and cost modifications and detailed information for the development of change orders
Provide and interpret resource requirements on a regular basis to ensure that programmers within the department are utilized as fully and as efficiently as possible
Ensure all Statistical Programming activities are carried out in accordance with Covance or project specific processes
Ensure the quality work of the group and department through ongoing quality management and review to ensure high quality deliverables to clients and internal customers
Interact with the management and wider team in related disciplines e.g. Clinical Data Management, Clinical and Biostatistics, to ensure consistency in approach, ongoing co-operation and teamwork and regular discussion regarding process improvements
Devise recruitment strategies to maximize ability to find and recruit high caliber staff. Perform interview and selection
Ensure staff is provided with equal opportunities for personal development and career progression, and that the needs of the individuals are balanced against the needs of the business
Represent Statistical Programming department during audits, particularly those related to new client opportunities
Carry out all activities according to appropriate Covance SOPs, working within the framework of the Quality Management System and to GCP
A minimum of 10 years experience in provision of programming support for clinical trial management and reporting, preferably with at least 2 years of statistical programming responsibility with a CRO
Strong people management skills and supervisory skills gained from at least 3 years line management experience
Extensive experience and proven skills in the use of SAS within a clinical trials environment. Extensive experience in all processes / practices used within a Statistical Programming environment
Substantial knowledge of all aspects of clinical trials from initial study set-up to study completion. Complete knowledge and understanding of the processes and procedures used within a Statistical Programming environment and the ability to communicate to programmers and non-programmers alike
An excellent understanding of the roles and responsibilities of all related disciplines, e.g. Biostatistics and Clinical Data Management
Ability to apply extensive technical expertise and full knowledge of other related disciplines to provide consultancy and advice on programming and wider related issues to other departments and disciplines
Excellent organizational skills and the ability to delegate and prioritize work
Good interpersonal skills and the ability to communicate appropriately with all levels of staff throughout the global organization and confidently with other disciplines and external clients. Ability to promote a good team working environment, providing the client with a high quality service whilst recognizing our business needs
A proactive approach to developing and maintaining effective working relationships with staff in other disciplines, often in other locations and in working to achieve consistent processes and standards across them
A co-operative and team orientated approach
Project management skills and team leadership experience, as demonstrated by ability to organize and motivate project teams
Good interview skills to ensure successful recruitment of high caliber candidates
Good logistical skills in order to manage the work of a team / group of Statistical Programmers
Good general business awareness and an understanding of the business needs of a CRO

Manager, Statistical Programming Resume Examples & Samples

Supervision of less-experienced statistical programmers within project activities
Statistical Programming lead for large global or other major programs
Carry out line management responsibilities for assigned staff, including Performance Management and Development activities, disciplinary procedures and administrative activities
Provide training on statistical programming related topics
Contribute to review and amendment of departmental processes and supporting documentation
Project management activities for identified projects including financial, resource planning and utilization, timelines and milestone management
Maintain a positive approach, building a motivating and professional team environment
Provide input and review of new business proposals, including time and cost estimates and associated documentation; participate in associated client development activities
Represent the statistical programming during audits, particularly those related to new client opportunities
Perform ongoing financial review of projects assigned to, ensure that all issues are highlighted and resolved as quickly as possible and all non-contract tasks are identified, tracked and included in change order forms
8 years experience in provision of programming support for clinical trial management and reporting, or equivalent experience
Supervisory skills gained from lead program oversight of large scale projects utilizing project management skills and team leadership as demonstrated by the ability to organize and motivate project teams
Knowledge of all aspects of clinical trials form initial study set-up to study completion
Full understanding of the job roles in programming, to be able to identify training and development needs, opportunities for optimizing staff utilization and employing the most efficient practices
A willingness to make decisions, seeking advice from senior Statistical Programming staff to confirm decisions when necessary
Self motivation and the ability to work independently, excellent time management skills and the ability to work to tight deadlines whilst maintaining the highest standards of work

Manager, Statistical Programming Resume Examples & Samples

Work as a statistical programmer on drug development project teams. Primary responsibilities include the production of clinical trial deliverables (e.g. analysis datasets and specifications, well-documented SAS® code, summary tables, figures, listings and analyses) for internal projects in support of internal biostatisticians, as well as providing validation and review of key results for external projects
Programming of ad hoc requests for exploratory analyses and time-sensitive deliverables. Must be able to work in a standardized programming environment and communicate results and work product both verbally and in writing
Support internal biostatisticians in the production of clinical trial report deliverables, including analysis datasets and summary report outputs. 20% of Time
Provide validation and review services for internal and external projects. Write up and communicate findings, as necessary. 30% of Time
Write computer programs in SAS for the production of clinical trial deliverables, and document the same, in a manner consistent with internal SOPs. 20% of Time
Prepare/Review electronic submission deliverables (e.g. Define.XML, Reviewers Guide, XPTs). 10% of Time
Provide statistical programming representation on project teams. 10% of Time
Interact with other project team members, as necessary. Interact with external vendor personnel, as necessary. 10% of Time
Masters or Bachelors degree with 3-5 years programming experience in the pharmaceutical industry or equivalent experience
Proficiency in SAS/BASE, STAT, GRAPHICS and MACRO.Proficiency in SAS/BASE, STAT, GRAPHICS and MACRO
Extensive experience in creating/reviewing/validating analysis datasets, tables, figures and listings, as well as documentation necessary to support electronic submissions and publications
Working familiarity with clinical trial design and analysis activities and knowledge of regulatory guidelines and industry standards (FDA/CFR, ICH/GCP, CDISC SDTM and ADaM)

Senior Manager, Statistical Programming Resume Examples & Samples

Provide statistical programming support to clinical trials for regulatory submissions and various publications, posters, … etc
Support the Biostatistics function in statistical analysis including generating analysis data sets, patient listings, tables and figures for clinical trials
Develop and maintain the infrastructure for project files of SAS datasets and SAS programs
Provide statistical programming support to clinical trials for regulatory submissions and publications, and ad hoc or post hoc analyses. Generate analysis data sets, listings, tables and figures, as well as supporting documentation (i.e. define.xml) for clinical studies. 30% of Time
Function as lead programmer on single or multi-protocol projects, and participate in project team
Independently validate SAS data sets and outputs from CROs or other programmers. Prepare validation documentation. 20% of Time
Develop and maintain SAS programming infrastructure, macros and standards. Adhere to the company's and departmental SOPs, Working Instructions and Standards. Participate in the company's development and implementation of global analysis data standards, output formats, standard SAS programs, etc. 20% of Time
Proficiency in SAS/BASE, STAT, GRAPHICS and MACRO
Extensive experience in creating/reviewing/validating analysis datasets, tables, figures, listings, and documentation necessary to support electronic submissions and publications
Demonstrated NDA, sNDA submissions and ISS/ISE experience
Strong communication skills both oral and written
Strong organizational and time management skills and the ability to handle multiple assignments effectively and deal with ad hoc requests
Ability to proactively plan so as to minimize potential re-work, as well as effectively and efficiently problem solve

Manager, Statistical Programming Resume Examples & Samples

Manage Programming Team to include planning, assigning and directing work, appraising performance, guiding professional development, and addressing employee relations issues and solving problems
Provide expert review of process and methodology development work with regard to programming standards and validation procedures
Manage relationships with clients and provide programming technical expertise to both external and internal customers
Coordinate and participate in process improvements and interoffice/interdepartmental task forces; oversee collection and reporting of Statistical Programming metrics, implementation of revised work practices and creation of new guidelines
Industry expert in SAS Statistical Programming Clinical Trials; SAS Macros, SDTM/ADaM/CDISC
Working knowledge of E.D.C. systems
Base SAS Certification
Management experience with motivating, resource allocation, quality review and metrics of a Programming team
Strong Phase I experience a plus
B.S./M.A.+ in related life science/programming field

Manager Statistical Programming Western Resume Examples & Samples

Serve as a Stat Programming consultant for other members of the department and staff members from other Biostatistics departments within the company
Maintain knowledge and awareness of developments in statistical programming
May participate as high level lead Stat Programmer on major project(s)
Provide advanced technical expertise for internal and external clients
Independently bring project solutions to SP teams and the Statistical Programming department
Provide expert review of process and methodology development work with regard to SP standards and validation procedures
Manage staff in accordance with organization’s policies and applicable regulations. Responsibilities include planning, assigning, and directing work; appraising performance and guiding professional development; rewarding and disciplining employees; addressing employee relations issues and resolving problems. Approve actions on human resource matters
Participate in project meetings; keep up-to-date on project issues; keep Director informed of project issues
Coordinate and participate in process improvements and interoffice/interdepartmental task forces; oversee collection and reporting of Stat Programming metrics, implementation of revised work practices, new guidelines, and new software tools as they become available
Effectively recommend resource allocation at the site level so as to achieve target utilization rates and project realization rates
Manage project budget and resource requirements: understand the Scope of Work, budget and quote assumptions, estimate the work completed, manage Out of Scope and provide revenue and resource forecasts for groups of studies, integrated summaries or eSubmissions
Assist in the following: (i) sales meetings as required; (ii) overseeing proposal preparation; (iii) ensuring that all proposals bid by the department have an adequate budget, and sufficiently detailed set of budget assumptions
Advanced knowledge of SAS and technical database skills
Knowledge of statistics and/or the clinical drug development process (Phase I – V)
Sound judgment/decision making
Ability to lead and motivate a team

Manager Statistical Programming Resume Examples & Samples

9+ years of programming and clinical research or related experience Must have database management, SAS or PL/SQL programming experience
1+ year of leadership responsibility Proven leadership skills
Ability to train, supervise, and mentor other
Ability to facilitate communications with clients, project teams, departments and staff
Understand and track project budgets
Understanding of relational data base structure and experience working with complex data systems
Demonstrated strong attention to detail
Ability to effectively organize and manage multiple staff and assignments

Manager, Statistical Programming Resume Examples & Samples

Attend multidisciplinary team meetings, representing the programming function
Provide input on key study related documents produced by other functions (e.g. CRFs, Data Management Plan, SAPs, etc.)
Create or review and approve CDIS Ccompliant datasets and corresponding documentation for electronic submission to regulatory agencies

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