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 smallโteam 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 adโhoc 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 #J-18808-Ljbffr