Cytel

www.cytel.com

1 Job

1,556 Employees

About the Company

Cytel is the world’s leading data-science CRO, driving advancements in human health through robust analytics and innovative clinical trial software. For nearly four decades, we have set the standard in adaptive trial design, leveraging extensive data insights to inform strategy throughout every phase of drug development and commercialization. Our mission is clear: accelerate drug development, enhance success rates, and deliver better patient outcomes. With a comprehensive suite of services from innovative trial design to end-to-end biometrics and real-world evidence, our specialized, multidisciplinary team ensures optimal strategies for preclinical research, trial execution, market access, and reimbursement.

Headquartered in Cambridge, Massachusetts, Cytel has a global presence with over 2,000 employees across North America, Europe, and Asia. Learn more about how Cytel is harnessing the power of data to advance human health at www.cytel.com.

Listed Jobs

Company Name: Cytel
Job Title: Senior Statistical Programmer FSP
Job Description: Job Title: Senior Statistical Programmer FSP Role Summary: Lead and develop SAS-based statistical programming for Phase I–IV clinical trials, focusing on SDTM/ADaM data sets, tables, listings, figures, and efficacy analyses. Drive data manipulation, QC/validation, and submission document preparation. Collaborate with cross-functional teams, manage multiple projects, and ensure high-quality deliverables within stringent timelines. Expectations: - Demonstrate leadership in programming and project oversight. - Communicate effectively with internal and external stakeholders. - Deliver accurate, validated outputs that meet regulatory standards. - Adapt to shifting priorities and support global, cross-cultural teams. - Mentor or support junior programmers when required. Key Responsibilities: - Perform data manipulation, analysis, and reporting of clinical trial safety and efficacy data. - Generate and validate SDTM and ADaM datasets, as well as TLFs and ad‑hoc reports. - Execute QC/validation procedures and maintain data integrity. - Create and review submission documents, including define.xml and eCRTs. - Provide complex ad‑hoc reporting using raw data. - Lead or support study programming for immunology, respiratory, or oncology projects. - Ensure adherence to CDISC SDTM/ADaM standards and regulatory guidelines. Required Skills: - Advanced SAS programming, including data manipulation, procedure programming, and macro usage. - Extensive experience with CDISC SDTM and ADaM standards. - Strong QC/validation and troubleshooting abilities. - Proficiency in efficacy statistical analyses. - Knowledge of drug development lifecycle and clinical trial data handling. - Experience with define.xml and other submission documents. - Ability to manage multiple simultaneous projects and meet deadlines. - Excellent written and verbal communication skills. - Ability to work collaboratively within a global, cross‑cultural environment. Required Education & Certifications: - Bachelor’s degree in Statistics, Computer Science, Mathematics, or related field. - Minimum of 8 years of SAS clinical programming experience; 6 years with a master’s degree or higher. - Certified or demonstrable experience in study lead roles preferred.