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Sr. Statistical Programmer
Sr. Statistical ProgrammerRedbock - an NES Fircroft company • Boston, MA, United States
Sr. Statistical Programmer

Sr. Statistical Programmer

Redbock - an NES Fircroft company • Boston, MA, United States
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Position Summary

Our client is seeking a highly skilled Senior Statistical Programmer to join their team on a long-term contract basis. This is a hands-on role ideal for someone with experience in a small sponsor or biotech environment, where close collaboration with cross-functional teams is key. This position requires strong experience with Phase III studies, BLA submissions, and SAS Macro development.

The role will also focus on quality control (QC) of vendor-delivered programming outputs, with some in-house programming to validate and compare analysis datasets.

Key Responsibilities

  • Perform QC and validation of vendor-delivered analysis datasets, tables, listings, and figures (TLFs).
  • Develop and maintaining SAS macros to support analysis datasets (SDTM / ADaM), TFLs, and regulatory (BLA) submissions
  • Conduct limited in-house programming, primarily ADaM dataset development, to ensure vendor quality and compliance.
  • Collaborate closely with internal Biostatistics, Data Management, and Clinical teams to support ongoing clinical studies.
  • Ensure adherence to CDISC standards (ADaM and SDTM) and company programming best practices.
  • Participate in cross-functional discussions to resolve data or analysis-related issues and ensure timely delivery of submission-ready outputs.

Qualifications

  • 8-10+ years of hands-on statistical programming experience, preferably with a small biotech or pharma company
  • Proven programming experience supporting Phase III clinical trials and BLA (Biologics License Application) submissions
  • Must have advanced SAS macro development skills - experience developing and maintaining SAS macros to support analysis datasets (SDTM / ADaM), TFLs, and regulatory submissions
  • Strong working knowledge of CDISC ADaM and SDTM standards, as well as TLF programming.
  • Experience in Dermatology therapeutic area preferred.
  • Excellent communication skills and demonstrated ability to work cross-functionally in a fast-paced, collaborative environment.
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