Manager, Biostatistics
HybridGurgaon, State of Mahārāshtra, Republic of India
Job Summary
Direct development of statistical designs and analysis procedures for clinical protocols, ensuring alignment with project strategy and regulatory objectives. Collaborate with data sciences and programming to implement database standards and monitor data collection instruments. Propose novel statistical methodologies to improve study efficiency and sensitivity, while conducting all analyses specified in scientific protocols and analysis plans. Prepare oral and written reports to communicate results, represent statistical sciences at management reviews, and critically review regulatory submission documents. Partner with clinical and regulatory teams to create development strategies and lead communication between project teams and functional management. Train and mentor staff on statistical operations, assist in recruiting qualified personnel, and validate external statistical software to meet SOPS and regulatory requirements.
Required Qualifications
- Demonstrated good understanding of Phase I to Phase IV drug development
- Strong knowledge in the principles and techniques of statistical analysis, interpretation, and clinical relevance
- Knowledge of statistical analysis software SAS and R
- Ph.D. or M.S. in Biostatistics or Statistics
- At least 2+ years for PhD (or 5+ years for M.S.) of industry experience or equivalent in a pharmaceutical R&D environment
Desired Qualifications
- NDA/BLA experience with eCTD submission is a plus
- Dermatology or oncology drug development experience is a plus
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