Principal Biostatistician- Non-Clinical

2+ years

Not Disclosed

Hyderabad

10 Dec. 10, 2024

Job Description

Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Principal Non-Clinical Biostatistician
Location: Hyderabad, India

About the Job
At Sanofi, we are committed to chasing the miracles of science to improve people's lives. Our Hubs play a key role in innovation, performance improvement, and the remarkable work we do every day. As a Principal Non-Clinical Biostatistician, you will lead and support statistical activities for various Non-Clinical efficacy, safety studies, and CMC activities with minimal supervision. This is an exciting opportunity to be part of a global healthcare company and drive advancements in the biopharmaceutical field.

Main Responsibilities

Provide Non-Clinical statistical support across all stages of project development, from target identification to process development.
Take accountability for all assigned statistical deliverables for studies or activities in the Non-Clinical development area.
Perform statistical analysis using R (and other tools such as SAS, JMP, SIMCA, or internal software) to generate statistical reports and memos.
Review study plans, randomization, sample sizes, and analysis methods in compliance with Sanofi’s best practices, including for internal/external studies (e.g., Statistical Review of SPRs, technical reports, presentations).
Contribute to the development and support of statistical end-user tools, particularly RShiny.
Engage in internal working groups to develop state-of-the-art statistical methodologies and approaches.
Determine optimal design and sample sizes, especially for in vivo experiments under Animal Welfare Committee (AWC) guidelines.
Ensure compliance with policies, standards, external guidelines, and processes.
Present statistical results to project teams and stakeholders.
Collaborate with other functions in cross-functional teams, fostering teamwork, quality, operational efficiency, and innovation.
Represent statistics in scientific or technology working groups and cross-functional initiatives.

About You

Experience: Experience in the pharmaceutical or related industry with a strong background in Non-Clinical statistics applied to biopharmaceutical development.
Technical Expertise: Expertise in industrial statistics (descriptive & inferential), design of experiments, multivariate data analysis (PCA, PLS), statistical modeling, and simulation.
Skills: Demonstrated strong communication and interpersonal skills. Proficient in SAS, R, and other statistical tools; good knowledge of CMC regulatory guidelines (EMA, FDA, ICH Quality, Pharmacopeias), and QbD principles.
Education: MS or PhD in Statistics or a relevant field.
Languages: Excellent communication in English, both oral and written.

Why Choose Us?

Career Growth: Endless opportunities to grow your talent, whether through promotions or lateral moves, domestically or internationally.
Supportive Team: Join a forward-thinking team that works on cutting-edge innovations in biopharmaceuticals.
Comprehensive Rewards: Enjoy a rewards package designed to recognize and amplify your contributions.
Health & Wellbeing: Access to comprehensive health benefits, wellness programs, and at least 14 weeks of gender-neutral parental leave.

Sanofi is at the forefront of the evolution of Non-Clinical Biostatistics. Join us if you want to be part of transforming our vision into a reality.

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Principal Biostatistician- Non-Clinical

Job Description

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