Associate Director / Director, Statistical Programming

Role overview Lead statistical programming across clinical studies and development programs, combining technical delivery with operational and functional leadership. You’ll oversee accurate, traceable, timely, and submission-ready clinical data outputs, while helping build scalable standards, automation, and fit-for-purpose processes. The role also includes CRO and contractor oversight and close partnership with cross-functional teams.

Responsibilities - Direct programming deliverables for studies and regulatory submissions, including SDTM and ADaM datasets, tables, listings, figures, define.xml, and reviewer guides. - Plan and oversee integrated and exploratory analyses, clinical study report outputs, and responses to regulatory questions. - Establish and maintain programming standards, quality controls, documentation, and processes that support inspection readiness. - Oversee CROs and other vendors, manage timelines and risks, and coordinate priorities across clinical development functions. - Review validation findings, including those identified by tools such as Pinnacle 21, and ensure they are resolved and documented using a risk-based approach.

Requirements - Bachelor’s or advanced degree in a quantitative or life sciences discipline such as statistics, biostatistics, mathematics, computer science, data science, or a related field. - At least 10 years of statistical programming experience in pharma, biotechnology, or a CRO, including study or program leadership, regulatory submissions, vendor oversight, and functional or people leadership. - Advanced SAS skills, including SAS/BASE, macros, SQL, and ODS, with experience in clinical analysis and reporting. - Advanced knowledge of CDISC standards, including SDTM, ADaM, controlled terminology, define.xml, and implementation guidance. - Experience producing and overseeing clinical study report and submission deliverables; working knowledge of drug development, trials, statistics, GCP, ICH guidance, and electronic submissions. - Strong communication, judgment, attention to detail, and ability to manage competing priorities and influence across a matrixed organization.

Nice to have - Experience with global NDA, BLA, or MAA submissions, complex development areas such as rare disease or gene therapy, and regulatory inspections or post-submission analyses. - Familiarity with R, Python, XML, Git, metadata-driven reporting, reusable programming infrastructure, automated QC, or reproducible workflows. - Experience developing SOPs, work instructions, programming standards, vendor governance, or validated collaborative environments; familiarity with responsible AI-assisted programming.

Benefits and work setup - Remote work, with the US Eastern time zone preferred. - Travel of up to 10–15% depending on business needs; additional flexibility may be needed around database locks, submission milestones, or urgent regulatory responses.