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 dataProgram 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 outputCreate SDTM and ADaM Datasets and related documentationFulfill ad-hoc programming requestsOther duties as neededQUALIFICATIONS & REQUIREMENTS:15+ years of statistical programming experience in the pharmaceutical/biotech industries, good tenure with Sponsor companiesStrong submissions experience (BLA, NDA/sNDA and EMA), understanding submission requirements, and end to end programming experienceStrong experience with CDISC implementation – SDTM/ADAM, must be able to develop specifications from scratchDemonstrated ability performing all levels of programming activities for a clinical projectExperience working in the Cardiovascular or Neuromuscular areas is a plus