Principal Biostatistician – Vaccines

Clinical Outcomes Solutions

Biostatistician supporting Vaccines projects across drug development. Leading statistical analyses and ensuring compliance with clinical trial standards.

Posted 7/3/2026full-timeRemote • 🇮🇳 IndiaLeadWebsite

About the role

Key responsibilities & impact

Provide statistical leadership and statistical expertise into clinical development plans, concept sheets and protocols for clinical development projects, represent Cytel and the statistical team on the Product Development Teams of sponsors.
Work with client statistical team, ensuring alignment of objectives and delivery of statistical output on time and meeting project requirements, coordinating all statistical aspects across clinical trials of each assigned project.
Provide statistical input into study protocols, Case Report Forms, and data management plans, write statistical analysis plans, review or create analysis dataset specifications, and perform statistical analyses.
Review and contribute to study reports and clinical and statistical sections of regulatory submission dossiers, lead electronic submissions of clinical data to regulatory authorities, and participate to meetings with regulatory authorities.
Develop strong collaboration and communication with sponsor cross-functional teams and sponsor Biostatistics management.

Requirements

What you’ll need

MS or PhD in statistics, biostatistics, or related fields with relevant industry working experience.
2+ years experience working in clinical trial setting.
Proficient with SAS. R is nice to have.
Have experience in authoring and reviewing SAP/TLF shells.
Familiar with CDISC standards. Have experience in reviewing SDTM/ADaM specs.
Have experience in programming and validating SDTM/ADaM/TLFs.
Experience in submission is a plus
Experience with Vaccines studies is preferred.
Strong communication, both verbal and written.

Benefits

Comp & perks

Here at Cytel we want our employees to succeed and we enable this success through consistent training, development and support.

ATS Keywords

✓ Tailor your resume

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools

Statistical Analysis PlansStatistical LeadershipStatistical ExpertiseProgramming And Validating SDTM/ADaM/TLFsAuthoring And Reviewing SAP/TLF Shells

Soft Skills

Strong CommunicationCollaboration