Lead Statistical Programmer

Exciting Opportunity: Join our dedicated team working closely with a leading pharmaceutical client to drive groundbreaking innovations in patient treatment. As a Lead Statistical Programmer, you'll enjoy the blend of autonomy and ownership, playing a critical role in our client's transformative programs. Position Overview: This role reports to the Director of Biostatistics and Programming within our FSP Services division. As a Lead Statistical Programmer, you'll work independently, providing expert technical support while tracking project progress. Your extensive experience will be crucial in managing clinical development programs across diverse therapeutic areas and overseeing CRO programmers to ensure high-quality data summaries. You will be responsible for all reporting and analysis tasks for Sponsor clinical trials. Key Responsibilities: Generate SDTM, ADaM specifications, datasets, reviewer's guide, and define.xml files for multiple studies. Develop SAS programs to create datasets, and complex listings, tables, and graphs alongside statisticians. Deliver high-quality statistical programming outcomes, including the development, validation, and maintenance of SAS or R programs tailored to clinical development needs. Oversee CRO's statistical programming deliverables for various clinical studies, ensuring quality and adherence to 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, including 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 timelines and objectives. 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 in a Biotech/Pharma Clinical Development Biometrics Team or similar settings. Exceptional SAS programming skills and expertise in implementing programming processes in clinical development. In-depth experience with CDISC standards (SDTM, ADaM, and Define.xml) and FDA/ICH regulations. Experience supporting regulatory submissions and interacting with FDA or global regulatory authorities. Ability to work independently and proactively. Strong communication (written and verbal) and leadership abilities. 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: 2026-03-04