Lead Biostatistician
On-siteBengaluru, Karnataka, India
Job Summary
Develop statistical analysis plans, calculate sample sizes for Alpha, Beta, CE/IVD trials, and generate final statistical analysis reports for regulatory submissions. Administer and maintain statistical software licenses including SAS, JMP, and Minitab while providing support to R&D teams and mentoring junior biostatistics teammates. Serve as the primary point of contact for FDA and other regulatory agency inquiries regarding study design and analysis. Conduct supporting analyses for precision, reproducibility, limit of detection, and method comparison studies. Requires a Master's or PhD in statistics with 6+ years of industry experience and proficiency in SAS, R, and Python. Reports to the Clinical Affairs Manager, Global QRC On-market Sustainment in an on-site role in Bengaluru, India.
Required Qualifications
- Master's or PhD in statistics, public health, or epidemiology
- Minimum of 6 years of related industry experience
- Basic and Advanced SAS certifications
- Demonstrated proficiency in statistical methodologies including DOE, regression, contingency tables, logistic regression, multivariate analysis, and ANOVA
- Programming experience in R and/or Python
- Ability to independently program in SAS, including macro development, with documented use in more than 3 major submissions or projects
- Proficiency in statistical software systems such as JMP, Minitab, or NCSS for statistical analysis and quality checks
- On-site role in Bengaluru, India
Desired Qualifications
- Certified Advanced programmer for SAS
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