Senior Biostatistician
Beckman Coulter Diagnostics (company site, opens in a new tab)8+ yrsBengaluruOn-siteDirect career pageEst. 25–40 LPA
Posted 10h ago
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Job description
Structured overview of role & requirements
About This Role
- Lead statistical support for clinical study design, analysis, and reporting for IVD molecular assays across infectious disease, hematology, and oncology applications.
- Provide statistical sections for clinical protocols, analysis plans, reports, and submissions to FDA and other regulators.
- Serve as point of contact for regulatory questions on statistical analysis and support audits, training, and SOP updates.
Minimum Requirements
- Bachelor’s in Statistics/Biostatistics with 8+ years, or MS with 6-8 years, or PhD with 4+ years of relevant experience.
- Experience as lead statistician in IVD, medical devices, or imaging clinical studies within regulated environments.
- Knowledge of FDA, CE-IVDR, WHO, diagnostics industry guidelines and statistical standards (e.g., CLSI).
- Proficiency in SAS, Excel, Minitab, Python or R; excellent oral and written communication.
Ideal Candidate Profile
- Demonstrated ability to translate scientific and engineering concepts into clear statistical methodologies understandable by non-statisticians.
- Experience working in global, regulated IVD or medical device environments requiring regulatory submissions.
- Operates effectively in a remote, globally distributed team supporting clinical and regulatory functions.