Senior Statistical Programmer

  • Contract
  • Remote


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Remote, 12-month contract with potential to renew

Senior Statistical Programming Consultant


  • Provide statistical programming support to generate SDTM and ADaM datasets, tables, listings, and figures for individual studies and ISS/ISE 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
  • Keep abreast of literature and advancements in SAS.


  • Bachelor’s or Master’s degree in biostatistics, computer science, or related fields, Master’s degree preferred;
  • At least 6 years of relevant experience 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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