Principal CMC Biostatistician (VAX)

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 CMC Biostatistician within our Hyderabad Hub, you’ll be responsible for building and developing a performing team, delivering biostatistics and programming activities throughout the R&D value chain (Pre-Clinical, Clinical, Translational, CMC) with our Vaccines Global Biostatistical Sciences team.

We are an innovative global healthcare company that helps the world stay ahead of infectious diseases by delivering more than 500 million vaccine doses a year. Across different countries, our talented teams are exploring new technologies to protect people and promote healthy communities. We chase the miracles of science every single day, pursuing progress to make a real impact on millions of patients around the world.

• Define team priorities and goals in line with Global Biostatistical Sciences leadership team towards Vaccines Global Vaccines Unit ambition;
• Manage recruitment, onboarding and development plan for the Vaccines India Biostatistical Sciences team.
• Define training plans and coordinate the continuous trainings for staff in alignment with both Statistical & Programming Hub Heads and Vaccines Global Biostatistical Sciences onboarding program.
• Direct/oversee statistical support of the team according to allocated activities:
• Responsible for site resource planning in alignment with Vaccines Global Biostatistical Sciences team;
• Create a productive work environment; Ensure team compliance with SOPs and function standards; Promote teamwork, quality, operational efficiency, and innovation.
• Plan and track project activities, timelines, and resource use; Provide justification for planned resource needs.
• Conduct performance review, ensure individual development plans and assist in problem solving and corrective measures.

Represent Vaccines biostatistics and statistical programming to participate Hub management meetings and lead key cross function initiatives. Represent the Indian Hub at the Global Vaccines Biostatistical Sciences leadership team.

Support Hub Head on transversal activities within and across Hubs, interfacing with other teams (e.g., Pharma Biostatistics, Pharma Programming, Vaccines data management,…) to enhance the synergy; participate cross-function working groups for process development and optimization)

About you
You are a passionate leader with following experience and competences who like the challenge and growing into a new environment: Experience:

5-10 years experience as Statistician in CMC (Chemical manufacturing and control) studies/ activities, applying advanced statistical concepts to the validation of analytical methods (e.g. bioasss development), the development of product (e.g. stability modelling, comparability studies) to ensure state of the art quality and productivity.

Experience in vaccines

• Experience in applying statistics for improving the process (e.g. modelling and monitoring of bio process).
• Experience in reporting and communicating plans, results, and conclusions in the form of technical documents and presentations.
• Experience in performing complex exploratory statistical analyses with minimal specifications.
• Experience in supporting analyses for regulatory filings and addressing Health Authorities questions

Skills:

• Experience with statistical sciences applications, such as linear/non-linear models, design of experiments (DOE), multivariate analysis, control charts, modelling,
• Statistical and programming software, including SAS, R, JMP,…
• Excellent understanding of processes associated with CMC, GMP quality concepts (including ObD) used in pharmaceutical development and production
• Demonstrate interpersonal skills necessary for effective teamwork
• Demonstrate ability to organize multiple work assignments and establish priorities
• Eager to learn and explore new territories

Education:

Masters or PhD (preferred) degree in Statistics, Mathematics, Computer Science or related health sciences or equivalent experience