Principal Non-Clinical Biostatistician

Sanofi; Hyderabad; On-site; INR 1,000,000 - 1,500,000; Full time

Job summary

A leading biopharmaceutical company in Hyderabad is looking for a Principal Non-Clinical Biostatistician to lead statistical activities for Non-Clinical studies. The ideal candidate will have expertise in non-clinical statistics, a strong background in statistical analysis using R and SAS, and experience in the biopharmaceutical industry. This role involves ensuring quality deliverables while collaborating cross-functionally. Strong communication skills and knowledge of regulatory guidelines are essential for success in this position.

Qualifications

• Pharmaceutical or related industry experience.
• Excellent knowledge of statistical concepts and techniques.
• Ability to prepare statistical analysis for regulatory dossiers.

Responsibilities

• Lead and support statistical activities for Non-Clinical studies.
• Perform statistical analyses of laboratory data.
• Contribute to the development of statistical end-user tools.

Skills

Non-clinical statistics expertise

Statistical analysis using R

Interpersonal and communication skills

Industrial statistics knowledge

Statistical modeling and simulation

Education

MS or PhD in Statistics or relevant fields

Tools

SAS

JMP

SIMCA

Job description

*About the job* **Main responsibilities:*** Contribute to the reliability, scientific quality and optimization of project support from target identification to process development, by providing appropriate Non-Clinical statistical support* Accountable for all assigned statistical deliverables related to one or several studies or activities in the Non-Clinical development area.* Perform statistical analyses of data from the laboratories using R and possibly other languages (SAS, …) or standard statistical software used in Sanofi (JMP, SIMCA, internal tools), to deliver statistical reports/memo* Review study plans (randomization, sample size, analysis) and reports for internal or external studies (e.g., Statistical Review of SPRs, technical reports, presentations) according to Sanofi best practices* Contribute to the development and support of statistical end-user tools (mainly RShiny)* Participate to internal working groups and contribute to develop state-of-the art methodologies and statistical approaches* Determine optimal design and sample size in particular for in vivo experiments in the scope of Animal Welfare committee (AWC)* Respect Policies, Standards, external guidelines and processes* Presentation of statistical work package results to project team members and stakeholders* Ensure productive collaborations with other functions in cross-functional teams and in communicating with senior leadership.; Promoting teamwork, quality, operational efficiency, and innovation.* Represent statistics to participate in scientific or technology working groups or cross functional initiatives *About you** **Experience**:* + (MS) or (PhD) of pharmaceutical or related industry experience + Strong expertise in the field of non-clinical statistics applied to biopharmaceutical development + Proven expertise of industrial statistics (descriptive & inferential statistics, statistical process control), design of experiments, multivariate data analysis (PCA, PLS and related methods), statistical modelling and simulation* **Soft and technical skills**:* + Demonstrated excellent interpersonal and communication skills. + Good knowledge and good understanding of statistical concepts and techniques, eg. predictive modeling, repeated measure ANOVA, multivariate analysis, dose response. + Good knowledge of pharmaceutical research and development, eg. in-vitro testing, animal models, toxicology studies + Able to work in departmental computing environment, can do advanced statistical analyses using SAS, R and other languages. + Knowledge of CMC regulatory guidelines (EMA, FDA, ICH Quality, Pharmacopeias), QbD principles and ability to prepare statistical analysis for regulatory dossiers. + Use of standard commercial software e.g. JMP, SIMCA, MODDE* **Education**: MS or PhD in Statistics or relevant fields* **Languages**: Excellent communication in English, both oral and writtenDiversity und Inklusion sind in den Grundwerten von Sanofi verankert und spiegeln sich in unserer Arbeitsweise wider. Wir respektieren die Vielfalt unserer Belegschaft in Hinsicht auf ihre Herkunft, Erfahrungen und Lebensweisen. Wir erkennen die Bereicherung, die diese Vielfalt birgt, und fördern Inklusion sowie eine Arbeitsumgebung, in der diese Unterschiede sich weiter entwickeln können, zur Stärkung des Lebens unserer Mitarbeiter, Patienten und Kunden.**Principal Non-Clinical Biostatistician** within our Non Clinical Statistics Team at Hyderabad, you’ll Lead and support statistical activities for several Non-Clinical efficacy, safety studies or CMC activities, under minimum supervision of statistical team leader.