Senior Manager, Principal Statistician
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Protocol Intelligence
Data-driven signals on your job's competitivenessTier-1 pharma brand and Hyderabad metro increase candidate density, but specialized CMC statistics reduces competition.
Requires CMC manufacturing statistics and regulatory knowledge, limiting transferability across industries.
Explicit MS/PhD plus mastery of DOE, regression and JMP/SAS/R makes screening highly selective.
Job Description
Structured overview of role & requirementsAbout This Role
Provide statistical analysis, direction, and training to Global Product Development & Supply (GPS) stakeholders worldwide to address their statistical needs.
Collaborate with manufacturing, analytical, and technology teams to design studies and analyze complex data for process robustness, compliance, and improvement.
Develop and apply statistical methods to assure batch compliance, define specifications, sampling plans, and support method lifecycle including development, validation, and investigations.
Minimum Requirements
MS in Statistics, Biostatistics, or related field with 2+ years experience, or PhD with no additional experience.
Mastery of statistical methods including DOE, regression modeling, variance component analysis, multivariate analysis, process capability, and control charts.
Advanced skills in statistical software such as JMP, SAS, or R.
Work Experience Required: Minimum 2 years post-MS experience or PhD level.
Ideal Candidate Profile
Experienced in biopharmaceutical development and manufacturing, preferably with CMC statistics background.
Familiar with FDA/EMEA cGMPs and global regulatory compliance guidelines (e.g., ICH, USP) relevant to drug manufacturing and packaging.
Capable of managing multiple projects within a dynamic, cross-functional, and culturally diverse environment.