The Medical Affairs Statistical Programming Group within the Department of Biostatistics is responsible for developing software for the analysis of clinical study data for the Medical Affairs group.
Essential Duties:
- Program complex adhoc analyses in a fast-paced environment for medical affairs/publication purposes working outside of the standard programming function for R&D clinical trials
- Attend multi-disciplinary team meetings, representing the programming function.
- Develop software systems to generate displays of clinical study data as tables, listings, and graphs for Medical Affairs analysis requests.
- Assist statisticians by suggesting algorithms to address novel analysis requests
- Create and document archives of software, outputs, and analysis files.
- Create and maintain department SOPs related to statistical programming.
- Review draft clinical reports, journal articles, slide presentations, and other documents to assure that results are reported accurately.
- Possibly oversee work of internal contract programmers and external vendors.
- Provide time and resource estimates for project planning.
Required Knowledge, Skills, and Abilities
- Skilled in programming with SAS. Knowledge of additional programming languages a plus.
- Good knowledge of statistics methods such as GLM, Survival Analysis and the drug development process
- Experience as a lead programmer for a project and/or compound within the medical affairs environment.
- Ability to balance and prioritize multiple assignments and respond quickly to adhoc requests.
- Experience in performing analysis to support publications, conference presentations and internal decision making.
- Experience overseeing the work of internal contractors and possibly external vendors (CROs)
- Familiarity with CDISC standards, including SDTM and ADaM models
- Solid verbal and written communication skills
Required/Preferred Education and Licenses
- Bachelor’s Degree in Computer Science, Statistics, Mathematics, Life Sciences or other relevant scientific fields; Master’s Degree preferred
- Minimum of 7 years of experience in developing software to analyze clinical data using the SAS system
Regards,
Sara Almas Khan | Technical recruiter