Senior Biostatistician - Medical Affairs

Join Our Innovative Team as a Senior Biostatistician in Medical Affairs! We are looking for a passionate and experienced Biostatistician to be a key player in our Medical Affairs department. In this exciting role, you will be responsible for vital statistical activities that enhance the generation of post-approval value evidence. Your expertise will be crucial for study design, protocol development, data analysis, and reporting, with an emphasis on delivering analysis outputs independently. Key Responsibilities Include: Lead statistical initiatives to generate post-approval value evidence and facilitate reimbursement submissions. Conduct detailed post hoc analyses to strengthen publications and presentations. Review and compose abstracts, manuscripts, and regulatory documents. Collaborate effectively with multidisciplinary teams to support observational studies. Develop detailed statistical sections of study protocols and statistical analysis plans. Partner with Data Management and Medical Research to design electronic Case Report Forms (eCRFs). Provide expert statistical guidance throughout ongoing studies. Accountable for working with Statistical Programming to execute analyses for clinical trials, registries, and observational data that support Medical Affairs objectives. Contribute to observational study reports and regulatory documents, such as Development Safety Update Reports (DSURs) and briefing documents. Summarize and support the development of scientific articles based on data from sponsor studies. Engage in various activities and meetings that bolster the Biostatistics and Medical Affairs teams as needed. Qualifications Needed: PhD in Biostatistics, Statistics, or a related field with a minimum of 3 years of pharmaceutical biostatistics experience; or a master's degree with at least 5 years of relevant experience. Outstanding written and verbal communication skills, with strong presentation abilities. Proficient in SAS programming, demonstrating a history of delivering analysis outputs independently. Extensive experience in analyzing data from clinical study databases. Essential experience with post-approval observational and clinical studies. Thorough understanding of ICH GCP and industry best practices and standards. Familiarity with R programming language and other statistical software. Experience with CDISC standards, including SDTM, ADaM, and CDASH. Cytel Inc. is proud to be an Equal Employment / Affirmative Action Employer. All applicants are considered for positions without regard to race, color, religion, sex, national origin, age, veteran status, disability, sexual orientation, gender identity or expression, or any other protected characteristics.

Created: 2026-03-10