Associate Director/Director, Statistical Programming

Emmes

10d

About The Position

Associate Director/Director, Statistical Programming Be Part of One Team, One Purpose. At Emmes Group, we’re shaping the future of clinical research— where human intelligence meets cutting-edge technology to drive meaningful advancements in healthcare. With over 47 years of scientific excellence, we’ve led groundbreaking research in cell and gene therapy, vaccines, infectious diseases, ophthalmology, rare diseases, and neuroscience. Emmes, a technology enabled full-service CRO, is modernizing clinical trials and accelerating the development of life-changing therapies. We believe that every clinical breakthrough starts with people —people who are passionate, purpose-driven, and ready to make an impact. At Emmes Group, we bring People, Science, and Technology together to collaborate with our customers and deliver global health impact. Our culture is built on integrity, collaboration, and innovation, ensuring that every challenge is met with perseverance and accountability. The Associate Director/Director, Statistical Programming is a strategic and operational leader responsible for overseeing all statistical programming activities across the biopharma clinical development programs. This role ensures high-quality, regulatory-compliant programming deliverables to support clinical trials, regulatory submissions, and post-marketing studies. The Director will lead a team of programmers, collaborate cross-functionally with Biostatistics, Data Management, and Regulatory, and drive innovation and process optimization across programming functions. This role requires deep expertise in SAS programming, CDISC standards, regulatory submissions (e.g., FDA, EMA), and a proven track record in managing global teams and complex project portfolios.

Requirements

Master's Degree Computer Science, Statistics, Mathematics, Life Sciences, or related field.
12+ Years of experience in statistical programming in the pharmaceutical, biotech, or CRO industry.
5 years in a leadership or management level role managing programming teams.
1 year Experience managing vendors and CRO partnerships.
Expert knowledge of SAS programming and deep familiarity with CDISC SDTM and ADaM standards.
Proven experience supporting NDA and BLA and MAA submissions and responding to regulatory queries.
Strong understanding of ICH guidelines, 21 CFR Part 11, and global regulatory requirements.
Exceptional communication, collaboration, and leadership skills.

Responsibilities

Lead and manage a team of statistical programmers
Establish and implement organizational structure, hiring plans, and career development frameworks for the programming function.
Provide mentorship, guidance, and performance management to senior managers, leads, and staff programmers.
Define and execute global statistical programming strategy aligned with clinical and regulatory goals.
Oversee programming support for clinical trials from Phase I IV, including integrated summaries and regulatory submissions.
Contribute to corporate level planning, budget forecasting, resource allocation, and vendor partnerships.
Ensure high quality programming deliverables including SDTM, ADaM datasets, Tables, Listings, and Figures TLFs.
Lead submission planning and execution, including eCTD packages and Define.xml generation.
Serve as a technical expert on CDISC implementation and provide governance over global standards and compliance.
Act as the primary programming representative in senior leadership forums and regulatory interactions.
Collaborate with Biostatistics, Data Management, Clinical Operations, Regulatory Affairs, and external partners.
Oversee strategic partnerships with CROs and technology vendors, ensuring delivery quality and alignment.
Champion process optimization, automation, and innovation initiatives within programming workflows.
Lead the evaluation and implementation of new tools, platforms, and technologies e.g., R, Python, cloud based analytics.
Maintain compliance with industry standards, company SOPs, and regulatory expectations.
Performs other duties as assigned
Complies with all policies and standards