Associate Director/Director, Statistical Programming

Contact: Terra Parsons - View email address on click.appcast.io Location: Watertown, MA Work Arrangement: Onsite 3 days a week

We are seeking an experienced and strategic Associate Director or Director of Statistical Programming to lead programming efforts for a compound-level program spanning multiple clinical studies. This role will be instrumental in ensuring high-quality, timely, and compliant statistical deliverables in support of the company’s innovative degrader pipeline. The ideal candidate brings 8+ years of statistical programming experience in the pharmaceutical or biotechnology industry, a deep understanding of clinical trial conduct, data flow, and regulatory expectations, and the ability to balance strategic leadership with hands‑on programming. This individual will proactively identify risks, solve complex problems, and collaborate effectively with cross‑functional stakeholders and external partners.

Key Responsibilities:

• Lead statistical programming for a compound-level program, including programming strategy, timelines, and resource planning, to ensure timely, accurate, and regulatory‑compliant deliverables.
• Partner with Biostatistics, Clinical Development, Data Management, Clinical Operations, and other cross‑functional teams to align on timelines, priorities, and quality expectations.
• Partner with the PK/PD function to manage the blinded data process during the double‑blind period, ensuring role‑based data access in line with the blinded data management plan.
• Help coordinate the process for ongoing data review across programming, data management, and study team stakeholders, including data transfers and the delivery of required outputs.
• Oversee CROs and external vendors delivering SDTM, ADaM, and TLF outputs, with a focus on technical quality, consistency, and clear documentation.
• Manage in‑house programming projects, including setting up and maintaining the programming workflow (e.g., task assignment, validation, version control, and delivery) and overseeing in‑house programmers.
• Write SDTM and ADaM specifications, and develop, validate, and maintain datasets and TLFs to support data review, CSRs, publications, and ad hoc data requests.
• Support programming for regulatory submissions (e.g., Define‑XML, ADRG/SDRG, eCTD) and provide documentation and expertise for audits and inspections.
• Contribute to department standards, processes, and tools, including automation and AI‑enabled tools; mentor programmers as needed.
• Additional duties and responsibilities as required.

Skills and Experience:

• MS or equivalent degree in Statistics, Biostatistics, Computer Science, or a related field (BS with substantial relevant experience will be considered).
• 8+ years of statistical programming experience in the pharmaceutical or biotechnology industry, including experience supporting Phase I, II, and III clinical trials.
• Demonstrated leadership of programming activities for a compound‑level program, with proven experience influencing across functions.
• Proven experience overseeing CROs and external vendors, with accountability for quality, timelines, and deliverables.
• Deep, hands‑on expertise with CDISC standards (SDTM, ADaM, Define‑XML) and strong knowledge of regulatory submission requirements (e.g., NDA/MAA, eCTD); prior experience leading or contributing to at least one successful submission.
• Hands‑on experience writing SDTM and ADaM specifications and setting up and managing in‑house programming workflows and projects, including task allocation, validation, and quality control.
• Advanced SAS programming proficiency, with proven ability to independently produce high‑quality analysis datasets, tables, listings, and figures, including for ad hoc data requests.
• Strong expertise in programming and analyzing efficacy endpoints, with the ability to efficiently translate clinical objectives into analysis‑ready datasets and outputs.
• Experience supporting blinded data processes in double‑blind studies is strongly preferred.
• Demonstrated ability to collaborate effectively in cross‑functional settings, adapt quickly to a fast‑paced or startup environment, and manage competing timelines and priorities while maintaining quality.
• Quick learner who writes efficient, well‑organized, well‑documented code and adapts readily to changing requests.
• Proactive, solutions‑oriented mindset with excellent communication and leadership skills.
• Experience with R or Python is a plus.