Senior Statistical Programmer

Location: Remote, with flexibility to accommodate urgent deliverables during PT hours, if needed

Pay rate: $75-80/hour W2; $80-88 C2C

Summary: Our small Oncology client on the West Coast is seeking a Senior Statistical Programmer to support clinical trial submissions. This role will be responsible for SAS programming for SDTM, ADaM, and TLFs, support ISS/ISE and regulatory submissions (including BIMO), and collaborate closely with statisticians, lead programmers, and external vendors. This consultant will need to be comfortable working in a small‑team environment.

Primary Responsibilities:

• Develop SAS programs to generate and/or validate SDTM, ADaM & TLFs for analyzing clinical trials, supporting registrations, and creating reports for publications and other ad‑hoc analyses.
• Develop, validate and maintain macros and tools for general use within the Biometrics group to enhance the efficiency and quality of output produced.
• Draft and/or review data specifications for SDTM, ADaM & TLFs.
• Interact with Lead Programmer & Statisticians on status updates, timelines and content of deliverables.
• Support ISS and NDA including BIMO (datasets, define, reviewers guide).
• Collaborate with external vendors on Biometrics’ deliverables and provide quality oversight.

Experience

Required:

• 10+ years of experience in statistical programming.
• Strong SAS programming skills, including expertise with CDISC (SDTM and ADaM) & TLF programming.
• Must have strong experience integrating ISS/ISE data.
• Oncology therapeutic area expertise is required.
• Regulatory submission experience (NDA/BLA, BIMO).
• Ability to QC programming work from CROs.
• Strong communication skills with the ability to interface at all levels & comfortable communicating workload to assist in managing priorities.
• Knowledge of R is a plus.

Benefits:

• Medical insurance
• Vision insurance
• 401(k)
• Disability insurance