Senior Statistical Programmer We are partnering with an innovative, clinical-stage biotechnology organization seeking an experienced Senior Statistical Programmer to join its growing biometrics team. This is a highly visible role offering the opportunity to make a significant impact across clinical development programs while working in a collaborative, fast-paced environment. The ideal candidate will bring strong hands-on SAS programming expertise, experience working directly with clinical trial data, and a proven ability to independently drive programming deliverables from study startup through reporting and submission.

Key Responsibilities

Lead statistical programming activities across multiple clinical studies and development programs. Develop, validate, and maintain SAS programs for SDTM/ADaM datasets, tables, listings, and figures (TLFs). Transform and analyze raw clinical trial data to support statistical analyses and reporting activities. Produce high-quality outputs for data review, study reporting, and regulatory submissions. Collaborate closely with biostatistics, data management, clinical operations, and external partners to ensure timely delivery of programming milestones. Provide oversight of CRO programming activities, including review of datasets, TLFs, and other study deliverables. Ensure compliance with programming standards, industry best practices, and regulatory requirements. Support clinical study reports (CSRs), health authority submissions, and ad hoc analysis requests. Contribute to the development and enhancement of programming processes, standards, and efficiencies across the organization.

Qualifications

Required Bachelor's or Master's degree in Statistics, Biostatistics, Mathematics, Computer Science, or a related scientific field. 8+ years of statistical programming experience within biotechnology, pharmaceutical, or CRO environments. Demonstrated experience leading programming activities and serving as a key contributor within lean, fast-growing organizations. Advanced SAS programming skills with experience creating and validating analysis datasets and TLFs; experience with R is highly desirable. Strong understanding of clinical trial data structures and the ability to work directly with raw data to generate analysis-ready deliverables. Experience managing and reviewing outsourced programming work while maintaining internal ownership of deliverables and timelines. Ability to work independently, prioritize competing demands, and thrive in a collaborative environment. Availability to work Pacific Time Zone business hours. Preferred Experience supporting regulatory submissions and health authority interactions. Familiarity with CDISC standards, including SDTM and ADaM. Previous experience within a small biotech or emerging pharmaceutical company environment. Experience supporting multiple studies simultaneously across various phases of clinical development. Location: Remote (Pacific Time Zone preferred) Type: Contract/Consulting Opportunity (NO 3rd PARTY CANDIDATES WILL BE CONSIDERED FOR THIS ROLE) This is an excellent opportunity to join a growing biotech organization where you can take ownership of statistical programming activities, work cross-functionally with key stakeholders, and contribute directly to the success of clinical development programs.