Biostatistician- Lead
Location: Pune, Mumbai - Thane, Bangalore
• Experience: Senior Level
• Openings: 2
Job description
6+
years’ biostatistics experience within global pharma clinical development
(sponsor and/or CRO), with accountability for end-to-end statistical strategy
and deliverables.
Provide
statistical leadership across Phase I–IV trials, delivering protocol inputs on
study design, endpoints, estimands (ICH E9(R1)), randomization/blinding,
interim analyses, and missing-data strategy; contribute to CRF/EDC design to
ensure analyzable data capture.
Conduct
sample size and power estimation (including simulation where appropriate);
document assumptions, operating characteristics, and sensitivity analyses.
Experience
with advanced/innovative designs and methods (adaptive, Bayesian,
platform/master protocols, dose-finding, simulation)
Contribute
to clinical study reports (CSR), integrated summaries (ISS/ISE), briefing
documents, and responses to regulatory questions; support publications with
statistically sound interpretation.
Strong
familiarity with global regulatory guidance impacting statistical work (ICH
E9/E9(R1), ICH E3, ICH E6, FDA/EMA/PMDA guidance) and inspection readiness
expectations
Must have Skill Set:
Proficiency
in SAS (mandatory).
Working
knowledge of R is preferred.
Good
understanding of CDISC concepts (SDTM/ADaM) and their impact on statistical
analysis.