Job Title: Statistician – Pre-Clinical Discovery R&D; Role Type: Full time

About the Role
We are seeking a highly skilled and analytical Statistician to join our Pre-Clinical Discovery R&D; team. This group provides vital statistical expertise across diverse drug development, manufacturing, and regulatory submission activities encompassing both small and large molecule entities. In this role, you will collaborate closely with statisticians and Science & Technology teams within Pharmaceutical Sciences, delivering robust statistical support for drug substance, drug product, analytical method development, and regulatory compliance.

Key Responsibilities
• Provide statistical expertise and deliverables for drug substance, drug product, and analytical method development.
• Design and execute statistical models to support manufacturing processes, regulatory submissions, and scientific studies .
• Apply Design of Experiments (DoE) methodologies to ensure robust and efficient experimental planning.
• Perform advanced statistical analyses, model selection, and rigorous interpretation of experimental data.
• Partner with cross-functional scientific teams to gather requirements, translate complex biological or chemical challenges into statistical solutions, and derive actionable insights.
• Support process characterization,



analytical method transfer, validation, stability studies, and shelf-life predictions. Required Skills & Experience
• Advanced academic background: Ph.
D. or M.
Sc. in Statistics.
• Minimum of 3 years of hands-on experience applying core statistical methods in a professional or research environment.
• Proficiency in R programming for advanced statistical analysis, modeling, and data manipulation.
• Hands-on expertise in Design of Experiments (DoE).
• Strong analytical capabilities with deep knowledge of model selection techniques and result interpretation.
• Excellent communication and client engagement skills, with a proven ability to translate stakeholder needs into statistical frameworks.
• Adaptable problem-solving skills with a strong track record across technical domains. Preferred Qualifications
• Coursework, background, or dual education in a scientific discipline (e.g., Chemistry, Biology, Chemical Engineering).
• Prior professional experience working within pharmaceutical research and development or life sciences.
• Proficiency with data visualization tools such as TIBCO Spotfire or Tableau.
• Experience managing, querying, and interacting with scientific and R&D; databases. •

📌 Statistician – Pre-Clinical Discovery R&D (India)
🏢 Brihati Global Edge Solutions
📍 India