Opportunity For Sr Statistician & (PBPK) Modelling Specialist

Position Title: Senior Statistician & Physiologically-Based Pharmacokinetic (PBPK) Modelling Specialist

Experience Required: 8-10 years

Key Responsibilities

PBPK Modelling & Simulation: Develop, validate, and apply PBPK models to predict drug behaviour across populations, predict, support formulation development and identify dissolution safe space for bioequivalence (IVIVC).

Statistical Analysis: Design and conduct comprehensive statistical analyses of formulation and analytical experiment design, protocol and report preparation.

Statistical analysis of bioequivalence results to identify outliers, period and results significance.

Regulatory Support: Prepare PBPK modelling reports for regulatory submissions. Deficiency response/ justifications basis of in-vitro data to support specifications etc.

Population Pharmacokinetics: Develop and validate population PK models using non-compartmental and compartmental approaches for formulation development.

Cross-functional Collaboration: Work with clinical, formulation scientists, and regulatory specialists

Quality & Documentation: Maintain comprehensive documentation and validate all models and analyses according to company standards and regulatory requirements

Literature Review & Benchmarking: Stay current with advances in PBPK modelling, statistical methods, and regulatory guidance

Shelf life predictions: Generating trend data, control charts, etc for shelf life extrapolation basis of stability results.

Quality by Design: Well versed with QbD principles used in product development, risk assessment, statistical process optimization tools to improve product quality and cost optimization.