Senior Biostatistician - Non-Clinical at Sanofi Aventis US LLC

Hyderabad, Telangana, India -

Full Time

Start Date

Immediate

Expiry Date

07 Mar, 26

Salary

0.0

Posted On

07 Dec, 25

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Biostatistics, Statistical Analysis, R, SAS, JMP, Statistical Modelling, Data Analysis, Multivariate Data Analysis, Statistical Process Control, Experimental Design, Communication Skills, Pharmaceutical Research, Regulatory Guidelines, RShiny, CMC Guidelines, Quality by Design

Industry

Pharmaceutical Manufacturing

Description

About the job Our Hubs are a crucial part of how we innovate, improving performance across every Sanofi department and providing a springboard for the amazing work we do. Build a career and you can be part of transforming our business while helping to change millions of lives. Ready? As a Non-Clinical Senior Biostatistician within our Statistics Team in Hyderabad, you’ll Support statistical activities for several Non-Clinical efficacy, safety studies or CMC activities, under supervision of statistical team leader. We are an innovative global healthcare company with one purpose: to chase the miracles of science to improve people’s lives. We’re also a company where you can flourish and grow your career, with countless opportunities to explore, make connections with people, and stretch the limits of what you thought was possible. Ready to get started? 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 About you Experience: (Master) or (PhD) of pharmaceutical or related industry experience 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: Expertise in the field of non-clinical statistics applied to biopharmaceutical development Demonstrated excellent interpersonal and communication skills. Good knowledge and good understanding of statistical concepts and techniques Good knowledge of pharmaceutical research and development Able to work in departmental computing environment, can do advanced statistical analyses using SAS, R and other languages. Expertise in JMP JSL script; RShiny hosting on GitHub 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 written Pursue progress, discover extraordinary Better is out there. Better medications, better outcomes, better science. But progress doesn’t happen without people – people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let’s be those people. At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, ability or gender identity. Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com! Global Terms & Conditions and Data Privacy Statement Sanofi is dedicated to supporting people through their health challenges. We are a global biopharmaceutical company focused on human health. We prevent illness with vaccines, provide innovative treatments to fight pain and ease suffering. We stand by the few who suffer from rare diseases and the millions with long-term chronic conditions. With more than 100,000 people in 100 countries, Sanofi is transforming scientific innovation into healthcare solutions around the globe. Discover more about us visiting www.sanofi.com or via our movie We are Sanofi As an organization, we change the practice of medicine; reinvent the way we work; and enable people to be their best versions in career and life. We are constantly moving and growing, making sure our people grow with us. Our working environment helps us build a dynamic and inclusive workplace operating on trust and respect and allows employees to live the life they want to live. All in for Diversity, Equity and Inclusion at Sanofi - YouTube

Responsibilities

The Senior Biostatistician will support statistical activities for Non-Clinical efficacy and safety studies, ensuring the reliability and scientific quality of project support. Responsibilities include performing statistical analyses, reviewing study plans, and contributing to the development of statistical tools.