Senior Director, Head of Statistical Programming

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Full Time Malvern, PA, US

Uniquity Bio is seeking a highly experienced and strategic Senior Director, Head of Statistical Programming to lead and scale the Statistical Programming function within our growing Biostatistics and Data Sciences organization. This individual will provide both strategic and operational leadership across clinical development programs and will be responsible for the delivery, quality, and integrity of statistical programming outputs supporting clinical trials, regulatory submissions, publications, and internal decision-making.

The Senior Director will play a critical role in establishing programming standards, building scalable infrastructure, and driving operational excellence across all programming activities. This position requires deep technical expertise, strong leadership capabilities, and the ability to collaborate effectively within a dynamic, cross‑functional biotechnology environment.

The ideal candidate is a hands‑on leader with extensive experience supporting regulatory submissions, managing external vendors and CROs, and building high‑performing programming organizations within a fast‑paced clinical‑stage biotech setting.

• Define and lead the vision, standards, operational strategy, and long‑term scalability roadmap for the Statistical Programming function.
• Build, mentor, and develop internal statistical programming capabilities through strategic hiring, coaching, resource planning, and team leadership.
• Oversee the development, validation, review, and delivery of SDTM datasets, ADaM datasets, tables, listings, figures (TLFs), and related programming deliverables across clinical development programs.
• Ensure all programming deliverables meet internal quality standards, CDISC compliance requirements, and applicable regulatory expectations for global submissions.
• Provide technical and operational oversight for programming activities supporting clinical trials, regulatory submissions, publications, safety analyses, and ad hoc data requests.
• Drive programming strategy and readiness for regulatory interactions and submissions, including FDA, EMA, PMDA, NDA, BLA, and MAA activities.
• Establish, maintain, and optimize programming processes, standards, SOPs, macros, validation frameworks, and data governance workflows to improve consistency, efficiency, scalability, and inspection readiness.
• Lead and oversee relationships with external CROs, statistical programming vendors, and independent contractors, including scope management, quality oversight, timeline accountability, and budget management.
• Partner closely with Biostatistics, Data Management, Clinical Operations, Medical Writing, Regulatory Affairs, and Clinical Development teams to ensure alignment on study timelines, deliverables, and data quality expectations.
• Contribute to submission strategy discussions, inspection readiness activities, and responses to regulatory questions related to programming deliverables and data standards.
• Evaluate and implement innovative technologies, tools, and automation opportunities to enhance programming efficiency and reproducibility.
• Support organizational growth initiatives and contribute to broader departmental strategy and operational planning efforts.

• Bachelor’s, Master’s, or PhD in Statistics, Biostatistics, Computer Science, Mathematics, or related quantitative discipline.
• Typically, 12+ years of statistical programming experience within the biotechnology, pharmaceutical, or CRO industry, including leadership experience supporting clinical development programs.
• Demonstrated experience leading statistical programming activities across multiple phases of clinical development, including late‑stage studies and regulatory submissions.
• Deep expertise in CDISC standards, including SDTM and ADaM implementation.
• Expert‑level proficiency in SAS required; familiarity with R and/or Python strongly preferred.
• Strong understanding of clinical trial processes,…