Lead Statistical Programmer FSP

Sponsor-dedicated: Join a forward-thinking pharmaceutical company as a Lead Statistical Programmer, where you will play a key role in innovation and patient treatment. Working embedded within a global client with the unwavering support of Cytel, you will have the autonomy and ownership to make impactful contributions in this dynamic environment. Position Overview: This role reports to the Director of Biostatistics and Programming in the FSP Services business unit at Cytel. As a Lead Statistical Programmer, you will work independently with minimal supervision, tracking progress and providing expert technical support to team members. We are seeking a highly skilled senior statistical programmer to lead clinical development programs across diverse therapeutic areas and manage CRO programmers to ensure timely and high-quality data summaries. You will oversee all reporting and analysis activities for Sponsor clinical trials. Key Responsibilities: Generate SDTM and ADaM specifications, datasets, reviewer's guides, and define.xml files for multiple studies. Develop SAS programs to create datasets, complex listings, tables (including descriptive and inferential statistics in collaboration with a Statistician), and complex graphs. Deliver high-caliber statistical programming outcomes, developing, validating, and maintaining SAS and/or R programs tailored to clinical development programs' needs. Oversee CRO's statistical programming deliverables for multiple clinical studies, ensuring high quality and adherence to timelines. Assist in preparing clinical study reports, regulatory submissions, publications, annual DSUR, and exploratory analyses. Understand and adhere to FDA regulations applicable to clinical trial data reporting, including good clinical practice and guidelines for electronic submissions. Contribute to creating, maintaining, documenting, and validating standards for programming tools, outputs, and macros. Engage in development 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 partners (CROs, software vendors, clinical development partners, etc.) to achieve project timelines and objectives. Review and/or author SOPs and Work Instructions related to statistical programming practices. Qualifications for Success: Bachelor's degree in computer science, data science, mathematics, or statistics preferred. 7+ years of experience as a Statistical Programmer on a Biotech/Pharma Clinical Development Biometrics Team or similar experience in supporting drug development, medical device development, or intervention studies. Exceptional SAS programming skills and expertise in statistical programming processes within a clinical development context. Extensive practical experience with CDISC standards (SDTM, ADaM, and Define.xml), medical terminology, clinical trial methodologies, and FDA/ICH regulations. Experience with regulatory submissions and interactions with the FDA and/or global regulatory authorities. Ability to work independently. Excellent written and verbal communication skills with strong leadership abilities. Preferred Qualifications: Experience with pharmacokinetic data and the neuroscience field. Proficiency in languages or tools other than SAS, such as R, Python, Java, Shiny, Markdown, Unix/Linux, and Git. Cytel Inc. is an Equal Employment/Affirmative Action Employer, and we welcome applicants regardless of race, color, religion, sex, national origin, age, veteran status, disability, sexual orientation, gender identity or expression, or any other protected characteristics.

Created: 2026-03-06