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