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