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

Work arrangement
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