Senior Principal Statistical Programmer

This is a fully remote position, open to applicants in United States.

📋 Description

• Oversee the design, development, validation, and upkeep of SAS programs that produce SDTM, ADaM, and TLFs.

• Ensure adherence to CDISC standards, regulatory guidelines from the FDA/EMA, and internal SOPs.

• Work closely with Biostatisticians, Data Managers, and Clinical Operations teams to establish programming needs and timelines.

• Conduct quality control and peer reviews of deliverables.

• Serve as the technical subject matter expert in statistical programming.

• Provide mentorship to junior programmers.

• Assist in the preparation of clinical study reports, regulatory submission packages such as eCTD and ISS/ISE, and responses to regulatory bodies.

• Develop and enhance departmental processes, templates, and tools.

• Contribute to vendor oversight and offer technical guidance for outsourced programming tasks.

• Collaborate with data science and machine learning teams to integrate clinical and AI infrastructure.

• Support statistical programming efforts for clinical trials from Phase I through to regulatory submissions.

⛳️ Requirements

• A Bachelor’s or Master’s degree in Computer Science, Statistics, Mathematics, Life Sciences, or a similar field.

• A minimum of 10 years of experience in statistical programming within the pharmaceutical, biotechnology, or CRO sectors.

• Experience in oncology is preferred.

• Proficient in SAS/Base, SAS/Macro, SAS/SQL, and SAS/Graph.

• Familiarity with Python is preferred.

• Strong background in CDISC standards (SDTM and ADaM).

• Knowledge of define.xml and Pinnacle 21.

• Experience with regulatory submissions to the FDA and/or EMA.

• Exceptional problem-solving abilities and meticulous attention to detail.

• Capability to work both independently and collaboratively within a cross-functional team.

• Exposure to cloud-based data systems or programming within a validated GxP environment is preferred.

• Must currently be authorized to work in the United States.

• Required to disclose whether visa sponsorship will be needed now or in the future.

🏝️ Benefits

• Company-paid healthcare.

• Flexible spending accounts.

• Voluntary life insurance.

• 401K matching.

• Uncapped vacation.

• Onsite gym.

• Onsite dining.

• Brand-new state-of-the-art facility.