Job Title: Principal Non-Clinical Biostatistician
Location: Hyderabad, India
Company: Sanofi
About Sanofi
Sanofi is an innovative global healthcare leader dedicated to improving people's lives through scientific advancements. As a Principal Non-Clinical Biostatistician, you'll have the opportunity to shape the future of pharmaceutical development while supporting cutting-edge research in non-clinical studies and activities.
Key Responsibilities
Statistical Support and Project Optimization
Provide statistical support for Non-Clinical efficacy, safety studies, and CMC activities from target identification to process development, ensuring scientific quality and reliability.
Accountable for all statistical deliverables related to assigned studies or activities within the Non-Clinical development area.
Conduct statistical analyses using R, SAS, JMP, or other statistical tools to deliver statistical reports, ensuring robust analysis and interpretation.
Study Planning and Reporting
Review and contribute to the development of study plans (randomization, sample size, and analysis) and statistical reports for both internal and external studies.
Provide statistical reviews for study reports, technical reports, presentations, and other documentation according to Sanofi’s best practices.
Development of Tools and Methodologies
Contribute to the development of statistical end-user tools, especially RShiny applications.
Participate in internal working groups, advancing statistical methodologies and tools in the Non-Clinical space.
Optimal Design and Sample Size Determination
Determine optimal designs and sample sizes, particularly for in vivo experiments, in compliance with Animal Welfare Committee (AWC) requirements.
Collaboration and Leadership
Ensure productive collaboration across functions and with senior leadership, promoting teamwork, quality, and operational efficiency.
Present statistical findings to project teams and stakeholders, contributing to decision-making and overall project success.
Represent statistics in cross-functional teams, scientific or technology working groups, and initiatives.
About You
Experience
Experience in pharmaceutical or related industry with strong expertise in non-clinical statistics applied to biopharmaceutical development.
Proven expertise in industrial statistics (descriptive & inferential statistics, statistical process control, etc.), design of experiments, multivariate data analysis (PCA, PLS), and statistical modeling.
Skills
Technical Skills:
Proficiency in statistical analysis using tools like R, SAS, JMP, SIMCA, and MODDE.
Expertise in applying QbD principles, CMC regulatory guidelines, and preparing statistical analyses for regulatory dossiers (EMA, FDA, ICH, Pharmacopeias).
Strong knowledge of pharmaceutical research and development processes.
Soft Skills:
Excellent interpersonal and communication skills, with the ability to work cross-functionally and collaborate effectively.
Strong problem-solving abilities and an analytical mindset.
Education
MS or PhD in Statistics or a relevant field.
Languages
Fluent in English, both written and spoken.
Why Join Us?
Innovation and Career Growth: Be part of an international, innovative biopharma company, with endless opportunities for career growth through promotions, lateral moves, and international exposure.
Comprehensive Rewards: Enjoy a thoughtfully designed rewards package that recognizes your contributions and enhances your impact.
Wellbeing: Take advantage of health and wellbeing benefits, including high-quality healthcare, wellness programs, and gender-neutral parental leave.
Join us to be part of a team that is transforming the future of clinical trials and making a real difference in patients' lives.
Watch the 'One day at Sanofi' video and explore our Diversity, Equity, and Inclusion initiatives here.
Gujarat :
Ahmedabad | Ankleshwar | Baroda | Bharuch | Gandhinagar | Gujarat | Halol | Jhagadia | Mehsana | Tarasadi | Vadodara | Vapi |Maharashtra :
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Pondicherry (Puducherry) |Jharkhand :
Ranchi |Sikkim :
Rangpo |India :
Siliguri |Illinois :
Abbott Park | Bloomingdale | Champaign | Chicago | Deerfield | Glenview | Lake Forest | Lombard | Naperville | Norridge | Park RIdge | Round Lake |Maryland :
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