Senior Statistical Programming Lead

Join Our Innovative Team: Embark on a rewarding journey with our dedicated group working alongside a leading pharmaceutical client to advance groundbreaking patient treatment solutions. In the role of Senior Statistical Programming Lead, you will have the perfect mix of autonomy and responsibility, making a significant impact on transformative programs. Position Overview: This position reports to the Director of Biostatistics and Programming within our FSP Services division. As a Senior Statistical Programming Lead, you will operate independently, offering expert technical support while effectively tracking project progress. Your vast experience will be essential for managing clinical development programs across various therapeutic areas and supervising CRO programmers to ensure excellence in data summaries. You will handle all reporting and analysis tasks for clinical trials sponsored by our client. Key Responsibilities: Generate SDTM, ADaM specifications, datasets, reviewer's guides, and define.xml files for multiple studies. Develop SAS programs to create datasets and complex listings, tables, and graphs in collaboration with statisticians. Deliver outstanding statistical programming results, including the development, validation, and maintenance of SAS or R programs focused on clinical development needs. Oversee CRO's statistical programming deliverables for various clinical studies, ensuring quality and compliance with timelines. Assist in preparing clinical study reports, regulatory submissions, publications, annual DSUR, and exploratory analyses. Ensure compliance with FDA regulations regarding clinical trial data reporting and good clinical practices. Contribute to the documentation and validation of programming standards for tools, outputs, and macros. Participate in the design of CRFs, edit check specifications, and data validation plans. Review and/or author data transfer specifications for external vendor data. Collaborate with internal and external stakeholders to meet project deadlines and goals. Review and/or author SOPs and Work Instructions related to statistical programming practices. To Succeed in This Role, You Will Need: A minimum of a bachelor's degree in computer science, data science, mathematics, or statistics. 7+ years of experience as a Statistical Programmer within a Biotech/Pharma Clinical Development Biometrics Team or similar environments. Exceptional SAS programming skills and expertise in implementing programming processes in clinical development. In-depth knowledge of CDISC standards (SDTM, ADaM, and Define.xml) and FDA/ICH regulations. Experience with regulatory submissions and interactions with FDA or global regulatory authorities. A proactive and independent work style. Strong leadership and communication skills (both written and verbal). Preferred Qualifications: Experience with pharmacokinetic data and a background in neuroscience. Proficiency in additional programming languages or tools such as R, Python, Java, Shiny, Markdown, Unix/Linux, and Git. Cytel Inc. is proud to be an Equal Employment/Affirmative Action Employer. We consider all applicants for positions without regard to race, color, religion, sex, national origin, age, veteran status, disability, sexual orientation, gender identity or expression, or any other category protected by law.

Created: 2026-03-17