Manager, Statistical Programming Cover Letter

I would like to submit my application for the manager, statistical programming opening. Please accept this letter and the attached resume.

In the previous role, I was responsible for technical and/or operational leadership in the delivery of high quality and timely statistical programming for clinical studies, drug programs, and/or in support of NDA submissions.

My experience is an excellent fit for the list of requirements in this job:

• Works with department leadership and project teams to establish strategy, timelines, and resourcing of statistical programming and analysis deliverables within their area
• Ensures appropriate documentation across the lifespan of the study and asset for all programming deliverables and verifies proper Trial Master File filings when appropriate
• Ensures planning is in place for all programmed deliverables including consideration of special data types and downstream uses of data
• Works with statisticians, programming resources, and other colleagues as appropriate to ensure clear specifications for programmed deliverables are in place
• Provides solutions to complex programming issues using problem solving skills and previous experience
• Statistical Programming and SAS hands-on experience
• Adept at solving problems using skills based on experience and extrapolation to new situations
• Understanding of clinical data and relevant data standards

Please consider me for the manager, statistical programming opportunity. I am including my resume that lists my qualifications and experience.

In the previous role, I was responsible for additional expertise in the analysis of clinical trial as it relates to protocol development, case report form design and data collection.

Please consider my qualifications and experience:

• Extensive knowledge of routine statistical methodology and its application to programming
• Knowledge of vendor processes
• Demonstrated experience in developing successful partnerships within study teams
• Some exposure working across international boundaries and cultures
• Substantial statistical programming experience
• May participate in cross-IDAR or cross-functional initiatives/process improvements
• Working knowledge of Regulatory guidelines and publishing processes
• Recognized expertise in SAS programming and SAS macro code development with the understanding of other SAS products

I submit this application to express my sincere interest in the manager, statistical programming position.

Previously, I was responsible for ad-hoc programming support to Clinical Operations, Data Management, Statistical Programming, Biostatistics, Drug Safety, Clinical Science, Medical Writing and Drug Safety to ensure rapid access to clinical study data for data cleaning/validation, SAS listings review, TLF, dry runs, etc.

My experience is an excellent fit for the list of requirements in this job:

• Thorough knowledge of ICH guidelines and regulatory requirements
• Knowledge of vendor processes and best practices in outsourcing and oversight
• Demonstrated experience managing complex projects and developing successful partnerships within study and asset teams
• Strong written and oral communication skills, leadership, decision making, influencing, negotiation, and project management skills
• Sound knowledge and experience working across international boundaries and cultures
• Extensive knowledge of statistical methodology and its application to programming
• CDISC experience highly desirable
• Oncology and regulatory submissions experience highly desirable

I am excited to be applying for the position of manager, statistical programming. Please accept this letter and the attached resume as my interest in this position.

In the previous role, I was responsible for leadership and oversee the planning and execution of programming activities across multiple clinical and cross-trial activities as well as non-clinical activities.

Please consider my experience and qualifications for this position:

• This role is the programming point of contact at the study level, and will support at the asset/submission level
• Ensures adherence to high quality programming standards in the production of clinical reports
• Will deliver through combination of oversight of vendors/offshore support through hands on programming
• Works with department leadership and project teams to establish strategy, timelines, and resourcing of statistical programming and analysis deliverables for their study(ies)
• Will contribute to department level initiatives
• Proactive at communicating potential issues to upper management
• Good understanding of ICH and Regulatory Guidelines
• Thorough understanding of clinical data and relevant data standards

I submit this application to express my sincere interest in the manager, statistical programming position.

In the previous role, I was responsible for guidance on the resolution of highly complex clinical trial reporting problems within budget and timeline constraints while assuming high-quality standards.

Please consider my qualifications and experience:

• Knowledge of non-SAS programming packages/languages
• Accountable for the management and delivery of prioritized endpoints
• Manage budget and vendor resources applied to the development of standards
• Experience working through the development and release process outlined within the standards software development lifecycle (SDLC) practices and SOPs
• Works with statisticians, programming resources, and other colleagues as appropriate to ensure clear specifications for the standard software development
• Represents Programming Standards into Global Clinical Data Standards Governance Board
• Understanding of other SAS products
• Vendors (CROs)