Sanofi Recruitment Senior Biostatistician (Non-Clinical) in Hyderabad

Sanofi, a global life sciences company, is inviting applications for the position of Senior Biostatistician – Non-Clinical to join their Statistics Team in Hyderabad. This role is crucial for supporting statistical activities across various Non-Clinical efficacy, safety, and CMC (Chemistry, Manufacturing, and Controls) projects.

Main Responsibilities

The Senior Biostatistician will be accountable for statistical deliverables from target identification through process development, ensuring scientific quality and reliability.

Statistical Analysis: Perform statistical analyses of laboratory data using R (mainly), SAS, JMP, SIMCA, and other statistical software.
Study Design & Review: Review study plans (randomization, sample size, analysis) and reports (SPRs, technical reports) according to Sanofi best practices.
Methodology & Tools: Contribute to developing state-of-the-art methodologies and statistical approaches. Also, contribute to the development and support of statistical end-user tools (RShiny).
Animal Welfare: Determine optimal design and sample size for in vivo experiments, particularly regarding the Animal Welfare Committee (AWC) requirements.
Reporting: Present statistical work package results to project team members and stakeholders.
Compliance: Respect Policies, Standards, external guidelines, and processes.

Candidate Profile & Technical Skills

Category	Requirement
Essential Qualification	MS or PhD in Statistics or relevant fields.
Experience	Relevant pharmaceutical or related industry experience (expected for MS and PhD level).
Core Statistical Expertise	Proven expertise in industrial statistics (descriptive & inferential), Design of Experiments (DoE), multivariate data analysis (PCA, PLS), statistical modelling, and simulation.
Technical Software Skills	Able to perform advanced statistical analyses using SAS and R. Expertise in JMP JSL script and RShiny hosting on GitHub is desirable. Knowledge of standard commercial software like JMP, SIMCA, and MODDE.
Non-Clinical/Regulatory Knowledge	Expertise in the field of non-clinical statistics applied to biopharmaceutical development. Knowledge of CMC regulatory guidelines (EMA, FDA, ICH Quality, Pharmacopeias), QbD principles, and ability to prepare statistical analysis for regulatory dossiers.
Soft Skills	Excellent communication in English (oral and written), demonstrated strong interpersonal skills, and ability to work in a departmental computing environment.