Lead Biostatistician - Medical Affairs

Join Our Team as a Lead Biostatistician in Medical Affairs! We are seeking a dedicated and skilled Biostatistician to play a vital role in our Medical Affairs department. In this dynamic position, you will be responsible for critical statistical activities that enhance post-approval value evidence generation. Your expertise will be essential for study design, protocol development, data analysis, and reporting. This role also emphasizes your ability to deliver analysis outputs independently, without programmer support. Key Responsibilities Include: Lead statistical support for generating post-approval value evidence and reimbursement submissions. Conduct insightful post hoc analyses to bolster publications and presentations. Review and author abstracts, manuscripts, and regulatory documents. Collaborate effectively with cross-functional teams to support observational studies. Develop comprehensive statistical sections of study protocols and statistical analysis plans. Work closely with Data Management and Medical Research to design electronic Case Report Forms (eCRFs). Provide expert statistical guidance throughout the conduct of ongoing studies. Accountable for collaboration with Statistical Programming to implement analyses for clinical trials, registries, and observational data supporting Medical Affairs needs. Contribute to observational study reports and regulatory documents, including Development Safety Update Reports (DSURs) and briefing documents. Summarize and contribute to scientific articles based on data from sponsor studies. Participate in various activities and meetings to support Biostatistics and the Medical Affairs team as required. Qualifications Needed: PhD in Biostatistics, Statistics, or a related field with at least 3 years of pharmaceutical biostatistics experience; or a master's degree with a minimum of 5 years of relevant experience. Exceptional written and oral communication skills, along with strong presentation abilities. Proficient in SAS programming, with a track record of delivering analysis outputs independently. Extensive experience in data analysis with clinical study databases. Experience with post-approval observational and clinical studies is essential. Comprehensive understanding of ICH GCP and general industry practices and standards. Familiarity with the R programming language as well as 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: 2026-03-04