Your missionThe Associate Director / Director, Statistical Programming will provide technical and operational leadership for statistical programming across clinical studies and development programs. The role is accountable for the quality, accuracy, timeliness, traceability, and regulatory readiness of programming deliverables, including SDTM and ADaM datasets, tables, listings, figures, define.xml, reviewer guides, integrated analyses, exploratory analyses, and responses to regulatory questions.
This is a hands-on leadership role suited to a growing biotechnology environment. The successful candidate will combine strong programming expertise with strategic oversight of CROs and contractors, effective cross-functional partnership, and a practical focus on scalable standards, automation, and fit-for-purpose processes.
Job Description Required Qualifications - Bachelor's or advanced degree in Statistics, Biostatistics, Mathematics, Computer Science, Data Science, Life Sciences, or a related quantitative discipline.
- At least 10 years of statistical programming experience in the pharmaceutical, biotechnology, or CRO industry, including demonstrated study or program leadership, BLA/NDA/MAA submission experience, vendor oversight, and functional or people leadership.
- Advanced SAS programming skills, including SAS/BASE, SAS Macro, SAS SQL, ODS, and programming for clinical data analysis and reporting.
- Advanced knowledge of CDISC standards, including SDTM, ADaM, controlled terminology, define.xml, and associated implementation guidance.
- Demonstrated experience producing and overseeing programming deliverables for clinical study reports and regulatory submissions.
- Working knowledge of the clinical drug-development process, clinical trial methodology, statistical concepts, GCP, ICH guidance, and electronic submission expectations.
- Experience with data and submission validation tools such as Pinnacle 21 and with resolving validation findings in a documented, risk-based manner.
- Proven ability to manage multiple priorities, anticipate risks, negotiate realistic timelines, and deliver high-quality work in a fast-paced environment.
- Excellent written and verbal communication skills, sound judgment, attention to detail, and the ability to influence effectively in a cross-functional matrix.
Preferred Qualifications - Hands-on experience with global regulatory submissions, including NDA, BLA, MAA, or equivalent submissions, integrated summaries, information requests, inspections, and post-submission analyses.
- Experience in rare disease, gene therapy, ophthalmology, or another complex clinical-development setting.
- Experience with R and relevant clinical-development ecosystems; familiarity with Python, XML, Git, or metadata-driven reporting is an advantage.
- Experience building or governing reusable programming infrastructure, macro libraries, automated QC frameworks, and reproducible reporting workflows.
- Experience authoring or implementing SOPs, work instructions, programming standards, and vendor governance processes.
- Familiarity with validated cloud or collaborative programming environments and responsible use of AI-assisted programming tools.
Core Competencies - Clinical programming and regulatory submission leadership.
- Quality, compliance, and inspection readiness.
- Strategic planning and risk management.
- CRO and vendor oversight.
- Cross-functional influence and communication.
- Technical problem-solving and innovation.
Working Conditions - Work arrangement: Remote, US eastern standard time zone preferred.
- Travel: up to 10-15%, based on business needs.
- The role may require flexibility during database locks, major submission milestones, or urgent regulatory responses.
