Principal Biostatistician – Vaccines

This is a fully remote position, open to applicants in India.

📋 Description

• Lead statistical initiatives and provide statistical expertise for clinical development plans, concept sheets, and protocols related to clinical development projects, acting as a representative of Cytel and the statistical team within the Product Development Teams of sponsors.

• Collaborate with the client’s statistical team to ensure alignment of goals and timely delivery of statistical outputs that meet project specifications, managing all statistical components across clinical trials for each designated project.

• Contribute statistical insights to study protocols, Case Report Forms, and data management plans, author statistical analysis plans, review or develop analysis dataset specifications, and conduct statistical evaluations.

• Assess and contribute to study reports and the clinical and statistical segments of regulatory submission dossiers, oversee electronic submissions of clinical data to regulatory bodies, and engage in meetings with regulatory authorities.

• Foster strong collaboration and effective communication with sponsor cross-functional teams and Biostatistics management.

⛳️ Requirements

• MS or PhD in statistics, biostatistics, or related fields, accompanied by relevant industry experience.

• A minimum of 2 years of experience in a clinical trial environment.

• Proficient in SAS; knowledge of R is advantageous.

• Experience in authoring and reviewing Statistical Analysis Plans (SAP) and Table, Listing, Figure (TLF) shells.

• Familiarity with CDISC standards and experience in reviewing SDTM/ADaM specifications.

• Proven experience in programming and validating SDTM/ADaM/TLFs.

• Experience with submissions is a plus.

• Preference for candidates with experience in vaccine studies.

• Excellent verbal and written communication skills.

🏝️ Benefits

• At Cytel, we are committed to our employees' success, which we support through ongoing training, development, and resources.