Statistician

Job Description

Job Summary:

• This position is responsible for providing statistical analysis, direction, and training to service clients in Global Product Development & Supply (GPS) to ensure robust processes and methods, thereby delivering product quality and compliance.
• Areas of support include development, process improvement, tech transfer, validation, PAIs, clinical supplies, manufacturing, transportation, health authority filings, and regulatory responses.
• Support and guidance in relation to study design and data analysis are provided worldwide to the Client facilities.

Duties and Responsibilities:

• Support the GPS network stakeholders globally to understand their statistical needs and determine sound statistical techniques for use.
• Collaborate with Manufacturing, Manufacturing Science &Technology, and process analytics teams to design studies and analyze complex datasets, driving process robustness and improvement.
• Support Quality Control and Analytical Sciences & Technology teams in method lifecycle management and reference standard qualification, including development, validation, and investigations.
• Develop and implement statistical approaches for study design and data analysis to ensure batch compliance and reduce risks of rejection or recall.
• This may include Specification setting, Process Capability, Sampling plans, and product shelf life (expiry/retest periods).
• Perform thorough statistical analyses, provide data-driven insights, and recommend actionable solutions aligned with business needs.
• Demonstrates strong statistical expertise while thinking in a clear, conclusive manner.
• Reaches independent, logical solutions.
• Represent Global Statistics at Product Development, product protocol, and management meetings.
• Contributes to improvement and standardization of processes, procedures, and systems in relation to Statistics while maintaining flexibility where required.
• Furthers the statistical awareness and statistical process control competency of other Client personnel; participates in their training and development, as needed.
• Enhance statistical awareness across the organization by supporting training and development in statistical methods and process control.
• Foster a shared commitment to quality and compliance at every level.
• Model and reinforce Client BioPharma Behaviors in daily responsibilities.

Requirements:

• Required MS (with 2+ years of experience) or PhD (with no additional experience) in Statistics, Biostatistics, Applied Mathematics, or other related fields.
• Mastery of statistical methods such as Design of Experiments (DoE), Analysis of Variance (ANOVA), Mixed models, and Multivariate Analysis.
• Advanced skills using one or more statistical software (e.g., JMP, SAS, R, or Python).
• Ability to analyze and interpret scenarios, and through effective study design and statistical analysis, provide answers and appropriate courses of action.
• Capable of managing multiple projects in a dynamic environment.
• Strong communication skills and the ability to explain statistical techniques to non-statisticians.
• Biopharmaceutical development and manufacturing experience, with a strong preference for CMC statistics background.
• Familiarity with FDA, EMA, and other global regulatory compliance guidelines (e.g., ICH guidelines) related to drug manufacturing, packaging, and distribution.
• Knowledge of Statistical process control, Variance component analysis, and Bayesian methodology.