Associate Director/Director, Statistical Programming

Contact: Terra Parsons -

teamnt@penfieldsearch.com

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.