Lead Biostatistician

Job Summary

The Lead Biostatistician is responsible for providing statistical support for clinical study design, analysis, and reporting for registration/pre-market approval (CE-IVD and US-IVD) of qualitative and quantitative IVD molecular assays for blood biomarkers, hematology, infectious disease, and oncology applications across Danaher Diagnostics Op Cos. This position will be point of contact for regulatory questions pertaining to analysis.

This position reports to the Senior Director, Biostatistics and is part of the global Bioinformatics team within Danaher Clinical Center of Excellence located in Bengaluru, India.

In this role, you will have the opportunity to:

• Provide end-to-end statistical analysis support for IVD product life cycle development through creation and verification of multiplex biomarker signatures in infectious disease, blood diagnostics, and oncology to regulatory submission. This can involve the application of various statistical methodologies (general linear modeling, survival analysis, multivariate classification tools, etc.).
• Provide statistical input in clinical study designs including sample size estimates using OC and power curves while ensuring the team understands statistical risks of the study design and sampling plan used
• Author statistical section for clinical protocols, statistical analysis plans, statistical analysis reports, and clinical study reports submitted to FDA or other regulatory agencies.
• Review and update standard operating procedures for relevant functions, provide statistical training/education programs to junior statisticians as needed and support audits of clinical data.
• Provide expert biostatistics input for analytical studies such as reproducibility and precision studies, interfering substances, limit of detection (LOD), exclusivity and inclusivity studies, method comparisons, accuracy, and linearity study

Essential requirements

• Bachelor s Degree in Statistics or Biostatistics with 10+ years of experience OR MS in Statistics or Biostatistics with 8 to 10 years of experience OR PhD in Statistics or Biostatistics with 6+ 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 possibly as statistical team lead
• Knowledge of FDA, CE-IVDR, WHO and other diagnostics industry guidelines. The successful candidate will need to stay current on statistical standards (e.g. CLSI, etc.) and trends in the IVD industry as well as FDA and other regulatory agency 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 and to mentor junior statisticians

Travel and environment requirements

• Traveling less than 5%
• No physical demands

It would be a plus if you also possess previous experience in:

• IVD regulatory submissions and regulatory interactions with FDA CDRH and CE

Disclaimer: This job posting has been aggregated from external source. Role details, content, and availability are subject to change. Applicants are advised to confirm the latest information directly on the company website before applying.