Biostatistical Programming Manager
Key Responsibilities:
- Lead one, or more than one, study/project end to end and assume all the responsibilities of Study Lead Programmer
- Set the programming strategy for the studies and projects and ensure timelines, quality, and compliance of all deliverables
- Lead and manage specific programming tasks (e.g., all programming related activities of an integrated analysis that involves multiple studies for regulatory submissions) assigned to the team
- Participate in establishing the programming scope for a deliverable with the statisticians and the study team
- Participate in establishing detailed timelines that will ensure timely delivery of programming deliverables for a study or project
- Create and maintain programming related specifications (e.g., SDTM and ADaM) for the studies/projects
- Represent GSP at the Clinical Study Team (CST)
- Attend meetings for, and provide programming input into, cross-functional study start-up activities, including but not limited to CRF development, database specifications review, database development, IVRS specification review, data quality check specifications
- Initiate cross-functional team meetings as necessary
- Perform significant hands-on statistical programming, particularly for those most challenging deliverables
- Manage individual programmer work assignments to ensure timely, high-quality deliverables
- Provide technical leadership and guidance for study programming team
- Coordinate and monitor data issue reporting and resolution
- Coordinate with other SLPs to providing consistent deliverables across studies within a product
- Manage technical aspects of project (e.g., create/manage computing environment, lookup tables, etc.)
- Provide training and guidance to other programmers
- Assume some product level responsibilities as delegated by Global Programming Lead (GPL) and/or Programming Execution Lead (PEL).
What we expect of you
We are all different, yet we all use our unique contributions to serve patients. The professional we seek is a results-oriented, tech-forward programming leader with deep expertise in clinical trial operations and digital transformation.
Basic Qualifications:
- BA/BSc or higher degree in biostatistics, statistics, mathematics, computer science, or other related quantitative or scientific subjects, with at least 6 years of statistical programming experience in clinical development environment.
- Thorough understanding of clinical trial processes, from data collection to analysis reporting
- Proven record of superior statistical programming and problem-solving skills within clinical development environment
- Prior experience and ability to lead and manage statistical programmers in successful and timely completion of all programming related activities (including preparing data and programming specifications) for a study end-to-end
- In-depth knowledge on latest CDISC SDTM, ADaM, and Define standards along with strong ability to implement all aspects of those standards
- Advanced analysis and reporting skills in SAS, including SAS/STAT packages, among others
- Experience in data quality and compliance check tools
- Excellent project management skills and ability to lead multiple projects effectively
- Excellent oral and written English communication skills
- Ability to work effectively and successfully in a globally dispersed team environment with cross-cultural partners
- Willingness and ability to provide guidance to team members on technical and process questions
Preferred Skills:
- MSc or higher degree in statistics, biostatistics, mathematics, or related quantitative or scientific subjects
- Familiarity with open-source programming tools (R, Python), automation platforms, and emerging technologies in statistical programming
- Prior regulatory submission experience for drug approval
