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Medium - strong pharma brand and metro location, but specialized CMC statistics expertise limits applicant pool.
High: role requires pharma CMC statistics and regulatory knowledge, reducing cross-industry transferability.
High: explicit statistical qualifications required plus domain-specific CMC, DOE, and software proficiency filters.
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Provide statistical analysis, direction, and training to Global Product development & Supply (GPS) stakeholders worldwide.
Collaborate with manufacturing and analytical teams to design studies and analyze complex datasets for process robustness, method lifecycle, and product quality compliance.
Develop and select statistical methods to assure batch compliance, prevent rejections/reworks, and support regulatory standards globally.
MS degree with 2+ years experience or PhD with no additional experience in Statistics, Biostatistics, or a highly related field.
Mastery of statistical methods including Design of Experiments, regression modeling, 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 or PhD level statistical experience.
Experience in biopharmaceutical development and manufacturing, preferably in CMC statistics.
Knowledge of FDA/EMEA cGMPs and other global regulatory compliance guidelines relevant to drug manufacturing.
Ability to manage multiple projects and communicate complex statistical concepts effectively to non-statisticians in a dynamic, technical environment.