Associate Director, Statistical Programming

Role Summary

As Associate Director of Statistical Programming, you will be responsible for planning, execution, and quality of SAS programming deliverables to conduct statistical analyses in support of clinical trial results. This role is also responsible for submission readiness of study data packages per CDISC standards and FDA guidance, and enhancement of the statistical programming infrastructure of the Biometrics department as applicable.

Responsibilities

• Lead all statistical programming activities for 1 or 2 assigned clinical studies, ensuring high-quality deliverables across the full study lifecycle.
• Develop programming specifications based on the Statistical Analysis Plan and oversee the creation, validation, and delivery of CDISC-compliant SDTM and ADaM datasets, TLFs, Define.xml, and reviewer’s guides.
• Provide hands-on SAS programming support for key analyses, data exploration, and internal or regulatory deliverables as needed.
• Manage study programming timelines, coordinate dependencies, and ensure alignment with cross-functional study plans and milestones.
• Collaborate closely with Biostatistics, Data Management, Clinical Operations, and Safety teams to review requirements, refine specifications, and resolve data or programming issues.
• Review Data Management Plans, case report forms, data transfer specifications, and validation plans to ensure downstream programming readiness.
• Oversee CRO statistical programming activities, review outputs for accuracy and compliance, and ensure timely, high-quality delivery of datasets and analysis results.
• Validate CRO-generated SDTM/ADaM datasets, TLFs, and submission components using industry tools (e.g., Pinnacle 21) and resolve compliance issues.
• Develop and maintain SAS macros, utilities, and programming tools that improve efficiency, consistency, and scalability across study deliverables.
• Ensure adherence to CDISC standards, regulatory expectations, departmental SOPs, and best practices for statistical programming and data traceability.
• Mentor and provide technical oversight to junior programmers or contractors supporting assigned studies.
• Contribute to departmental initiatives, process improvements, and cross-functional projects beyond assigned study responsibilities.

Qualifications

• M.S. (or higher) in Statistics, Computer Science or other closely related field to programming with a minimum 10+ years of relevant pharmaceutical/biotech industry experience.
• Requires solid knowledge of statistical programming principles, clinical trials process and regulatory requirements.
• Prior NDA submission and regulatory agency interaction experience highly desirable.
• Prior Oncology/Hematology experience highly desirable.

Skills

• Dynamic self-starter; agile learner; strategic and creative thinker.
• Demonstrated strong problem solving and risk-mitigation skills.
• Excellent verbal/written and interpersonal skills required to communicate and collaborate effectively with cross-functional teams (clinical operations, Scientists, Medical Monitors and Statisticians) in face-to-face conversation, by telephone, and by email.
• Good working knowledge of ICH, FDA, and GCP regulations and guidelines.
• Strong well-rounded technical skills (SAS, EDC systems, MS Word, Excel, PowerPoint, API based data extracts, ETL principles) and knowledge of industry standards (CDISC, SDTM, CDASH, ADaM).