Senior Biostatistician
Remote · Bengaluru, Karnataka, India
Job Summary
Senior Biostatistician responsible for providing end-to-end statistical analysis support for IVD product development through creation and verification of multiplex biomarker signatures in infectious disease, blood diagnostics, and oncology to regulatory submission. Provide statistical input in clinical study designs including sample size estimates, write statistical sections for protocols, SAPs, and clinical study reports submitted to FDA or other regulatory agencies, review SOPs, and support audits. Act as the point of contact for regulatory questions pertaining to analysis; provide expert biostatistics input for reproducibility, precision studies, LOD, exclusivity/inclusivity studies, method comparisons, accuracy, and linearity. Collaboration with the global Bioinformatics team, with likely remote work from Bengaluru, India, and travel <5%. Proficiency in SAS, Python or R, Minitab, Excel required. The role emphasizes staying current with CLSI and other regulatory guidelines and applying advanced statistical methodologies (GLM, survival analysis, multivariate classification) across the product life cycle.
Required Qualifications
- Bachelor’s Degree in Statistics or Biostatistics with 8+ years of experience OR MS in Statistics or Biostatistics with 6 to 8 years of experience OR PhD in Statistics or Biostatistics with 4+ years of experience
- Work experience as a lead statistician in analysis and reporting of IVD, medical devices, and imaging clinical studies in a regulated environment
- Knowledge of FDA, CE-IVDR, WHO and other diagnostics industry guidelines
- Relevant knowledge and usage of SAS, Excel, Minitab, Python or R with excellent oral and written communication skills
- Ability to convert business, scientific, and engineering concepts into clear mathematical/ statistical concepts and the ability to express them in ways understandable to non-statisticians
- Travel, Motor Vehicle Record & Physical/Environment Requirements: Traveling less than 5%
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