Associate Director, SAS Programming

Required

• Detailed knowledge of clinical trial data, the drug development process, and regulatory requirements, including GCP, ICH, 21 CFR Part 11, and FDA, EMA, and PMDA electronic submission requirements.
• Experience constructing integrated datasets across multiple clinical trials to support integrated summaries of safety and efficacy.
• Experience with Pinnacle 21 or equivalent conformance tooling and resolution of conformance findings.
• Demonstrated ability to set programming strategy across multiple studies, plan resources, and guide lead programmers.
• Experience supporting NDA, BLA, or MAA submissions, including submission data packages and health authority responses, is preferred.
• Working knowledge of R is preferred.
• Practical use of generative AI tools to improve programming productivity and quality, with an understanding of their limitations and the validation expectations for AI-assisted outputs in a regulated environment.
• Excellent written and verbal communication skills, with the ability to convey technical concepts clearly and concisely to technical and non-technical stakeholders.
• Demonstrated initiative: recognizes what needs to be done, acts without waiting to be asked, follows through to results, and identifies opportunities for improvement and efficiency.
• Brings competence and care to the work: high technical standards and ownership of quality, combined with genuine care for colleagues, partners, and the patients behind the data.
• Balances competing priorities and deadlines, ensuring timely and high-quality execution.
• Willingness and ability to travel domestically and internationally as needed.