Sr. Statistical Programmer
SUMMARY: A biopharmaceutical company in the Bay area needs a very strong Senior Statistical Programmer to support their team. This programmer will need to be a strong, senior-level programmer who can work well both independently and part of a team. They must be proficient in their CDISC expertise and be able to program specifications from scratch (both SDTM and ADaM programming). DUTIES & RESPONSIBILITIES:
- Perform data manipulation, analysis and reporting of clinical trial data
- Program and generate tables, listings, and graphs (TLGs)
- Participate in the review of statistical analysis plans, table specification, develop specification for SDTM and ADaM data sets.
- Review, and comment on CRFs, annotated CRFs, and edit checks and related documents.
- Participate in study team meetings and address issues that may affect statistical programming.
- Validate and document SAS programs and output
- Create SDTM and ADaM Datasets and related documentation
- Fulfill ad-hoc programming requests
- Other duties as needed
QUALIFICATIONS & REQUIREMENTS:
- 15+ years of statistical programming experience in the pharmaceutical/biotech industries, good tenure with Sponsor companies
- Strong submissions experience (BLA, NDA/sNDA and EMA), understanding submission requirements, and end to end programming experience
- Strong experience with CDISC implementation – SDTM/ADAM, must be able to develop specifications from scratch
- Demonstrated ability performing all levels of programming activities for a clinical project
- Experience working in the Cardiovascular or Neuromuscular areas is a plus