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Job Description
Structured overview of role & requirementsAbout This Role
Develop Statistical Analysis Plans and calculate sample sizes for Alpha, Beta, CE/IVD clinical trials.
Oversee statistical programming and author final statistical analysis reports for regulatory submissions.
Serve as point of contact for FDA and other regulatory questions related to study design and analysis, and provide statistical support across clinical and new product development studies.
Minimum Requirements
Master's or PhD in statistics, public health, or epidemiology.
Minimum of 6 years related industry experience in biostatistics or clinical trial statistics.
Proficiency in SAS programming including macro development, with documented use in 3+ major submissions or projects.
On-site work location: Bengaluru, India.
Ideal Candidate Profile
Experienced with advanced statistical methodologies like DOE, regression, logistic regression, multivariate analysis, and ANOVA.
Capable of administering statistical software licenses (SAS, JMP, Minitab) and mentoring junior biostatistics staff.
Familiarity with regulatory submission processes and comfortable interfacing with FDA and regulatory agencies on statistical matters.