Specialist CMC Statistician

We are seeking a highly skilled Specialist CMC Statistician to join our Global CMC Statistics (GCS) team. This role is vital for supporting the entire product lifecycle of new molecules and commercial products by applying advanced statistical tools and techniques. The ideal candidate will have a strong background in Applied or Industrial Statistics , with proven experience in the biopharma manufacturing and control environment. You will be a key partner in ensuring product quality, improving compliance, and driving continuous improvement through data-driven insights.

Responsibilities

• Statistical Support : Provide continuous statistical support to manufacturing and functional groups by designing experimental studies, performing statistical analyses, and documenting results in technical reports.
• Regulatory Compliance : Prepare written responses and perform additional analyses to support regulatory submissions and address questions from agencies.
• Tool Development : Participate in the development and maintenance of statistical tools used for product lifecycle activities, including drafting white papers, writing standardized code in R and SAS , and creating report templates.
• Continuous Improvement : Contribute to improvement efforts by promoting statistical techniques in biologics and monoclonal antibodies processes. You will also mentor and guide technical associates on statistical methods and software.
• Knowledge & Training : Stay updated on industry trends and guidance documents, participating in external conferences as appropriate. You will also administer statistical training for engineers and scientists.

Qualifications

Skills Required

Statistical Analysis, R Tool, Sas Admin, Continuous Improvement, Biopharmaceutical Manufacturing, Process Control