Lead Biostatistician (Vaccines - R&D)

Function / Department : Vaccines R&D

Position Title / Role : Lead Biostatistician

Job Location : Corporate Office, Jubilee Hills, Hyderabad

Main purpose of the Job:

• Provide statistical leadership across the Vaccine R&D portfolio, supporting preclinical and clinical trials.
• Serve as the principal statistical advisor to Vaccine R&D leadership, ensuring scientifically robust study designs and data analyses for vaccine development programs.

Key Responsibilities:

• Provide statistical leadership and support across preclinical, translational and clinical development programs.
• Design statistically robust preclinical studies, assay qualification, and clinical trials.
• Develop statistical methodologies, including experimental design, sample size determination, randomization, Statistical Analysis Plans (SAPs) and data interpretation.
• Provide statistical support for immunogenicity, safety, efficacy, assay performance, integrated analyses and scientific publications.
• Oversee and review statistical deliverables from external CROs and statistical programming partners to ensure quality and regulatory compliance.
• Collaborate closely with pre-clinical, analytical development, CMC and clinical development to provide end-to-end statistical support.

Candidate desired skills

• PhD (preferred) or Master's degree in Biostatistics or a related quantitative discipline.
• 10+ years of experience in pharmaceutical or vaccine R&D.
• Experience supporting preclinical and clinical development, preferably for vaccines.
• Experience with global regulatory submissions
• Strong knowledge of statistical methods for experimental design, assay validation and clinical trials.
• Excellent communication, scientific judgment and the ability to influence multidisciplinary teams.

For more details, visit us www.biologicale.com