Biological E.
Website:
biologicale.com
Job details:
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
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