Senior Manager Statistical Programming

Role Summary

The Senior Manager Statistical Programming for Medical Affairs provides timely support to the Medical Affairs project team on all programming matters according to the project strategies within a therapeutic area. As an integral part of a project team, the incumbent provides project leadership and contributes to the programming support for processing data from clinical studies. Project requirements will be identified according to a Statistical Analysis Plan, programming specifications or user requirements/design documents using internal standards and guidelines. The incumbent is responsible for leading the programming aspect of the project, both internally or CROs, for all programming deliverables and participates in the identification and development of programming standards and macro development to facilitate the creation of statistical deliverables from a single study through to regulatory approval, product launch, and annual reports. The Senior Manager Statistical Programming for Medical Affairs may serve as the statistical programming lead for indication(s)/product(s) within Medical Affairs.

Responsibilities

• Independently coordinate and oversee the preparation, execution, reporting and documentation of project analysis programming within a therapeutic area using appropriate tools to track, allocate and summarize extent of work required, progress and completion of programming deliverables. Manage and coordinate programming and QC of analysis datasets and TFLs following Regeneron standard data models and/or integration of data across studies.
• Implement and mentor others on the use of department standardization tools or therapeutic area standard analysis when programming clinical data or system application deliverables.
• Contribute to programming development and quality control of the programming deliverables utilizing Regeneron tools and methodologies.
• Programming representative within a therapeutic area in a multidisciplinary study team to ensure timely and quality support for analysis and reporting of clinical trial data
• Provide input into Medical Analytics policies and process improvement work streams (scientific, systems and process). Enforce and promote internal policies, systems, and processes.
• Contributes to cross-functional process improvement and technical working groups between BDM and Medical Affairs/HEOR for statistical programming related topics.

Qualifications

• Advanced SAS programming skills in a clinical data environment with expertise in at least one therapeutic area.
• Extensive understanding of relational databases and experience working with complex data systems.
• Experience in pharmaceutical clinical development and ability to provide programming support and leadership for BLA and other regulatory submissions.
• Experience in working on a submission to regulatory authorities.
• Knowledge of regulatory requirements concerning electronic submission standards.
• Experience in creation of current CDISC data structures.
• Leadership experience, especially in the hiring, development, evaluation and support of junior staff and contractors.

Skills

• Statistical programming leadership
• Clinical data management and analysis
• Regulatory submissions support
• Data standards and CDISC
• Cross-functional collaboration

Education

• MS (BS) in Statistics, Computer Science, Mathematics, Engineering, Life Science or related field with 8+ years of programming experience preferably in processing clinical trial data in the biotechnology, pharmaceutical or health related industry.