Sr. Statistical ProgrammerRedbock - an NES Fircroft company • Boston, MA, United States
Sr. Statistical Programmer
Redbock - an NES Fircroft company • Boston, MA, United States
[job_card.variable_days_ago]
[job_preview.job_type]
- [job_card.full_time]
[job_card.job_description]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.
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
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