Statistical Programmer

5 days ago

San Francisco, CA, United States Katalyst Healthcares and Life Sciences Full time
Responsibilities:
  • Provide statistical programming support to generate SDTM and ADaM datasets, tables, listings, and figures for individual studies and ISS/Client to FDA, EMA, and other worldwide regulatory agencies.
  • Participate in the review of statistical analysis plans and TLF specifications.
  • Review or annotate CRFs for SDTM mapping, review/author SDTM/ADaM dataset specifications.
  • Review, and comment on CRFs, vendor data transfer specifications (DTS), edit checks and other study data related documents.
  • Support in the preparation of study reports, regulatory submissions, and annual safety update reports.
  • Perform additional analysis and validation for data checking, publication, presentation, poster, and ad hoc analysis.
  • Work with CRO statistical programmers and perform statistical programming vendor oversight.
  • Contribute to Biometrics SOPs and work instructions related to EDC studies, FDA requests, and statistical programming processes.
  • Contribute to department process improvement initiatives.
  • Support department infrastructure builds up by developing, validating, and testing the macros, utilities, and tools.
  • Keep abreast of literature and advancements in SAS.
Requirements:
  • Bachelor's or master's degree in biostatistics, computer science, or related fields, master's degree preferred.
  • t least 8+ years of relevant experience, including as a Lead Statistical Programmer, in the biotech or pharmaceutical industry.
  • The ideal candidate must be able to communicate effectively within a multi-disciplinary project team to assess priorities and complete assigned tasks on time.
  • Proficient of SAS programming in a regulated clinical research environment.
  • Experience of programming and validation of SDTM and ADaM data sets, tables, figures, and listings.

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