Principal Biostatistician

About the job

Our Team:

Sanofi Business Operations is an internal Sanofi resource organization based in India and is setup to centralize processes and activities to support Specialty Care, Vaccines, General Medicines, CHC, CMO, and R&D, Data & Digital functions. Sanofi Business Operations strives to be a strategic and functional partner for tactical deliveries to Medical, HEVA, and Commercial organizations in Sanofi, globally.

Main responsibilities:

The Principal Biostatistician will work with Medical Affairs biostatisticians and/or programmers and Sanofi Business Operations biostatistics and programming personnel to implement statistical analysis plans (SAP), programming specifications for analysis datasets and provide QC done data packages including tables, figures, and listings for use in publications (i.e., abstracts, posters, oral, presentations, manuscripts and ad-hoc data analysis requests) and to investigate the natural history of a TA diseases and long-term treatment outcomes of observational data using clinical trials and / or Registries as applicable; The Principal Biostatistician will ensure SOPs are followed, communications, timelines and quality metrics are met.; Collaboration of Local biostatistics and programming teams, Global Medical Affairs biostatisticians and / or programmers, and Global Medical Affairs Scientific Communications personnel.

People:

1) Develop and maintain effective relationships and collaborations with the end stakeholders (Medical community) and local biostatistics and programming team members within the allocated Global business unit and product – with an objective to develop statistical data outputs.

2) Support Sanofi Business Operations Leadership Team in understanding of stakeholders needs & expectations and provide end to end solutions for TAs/indications.

3) Coach/mentor new team members to support efficient and quick onboarding.

4) Support graduate hiring program as needed.

Performance / Process:  

1) Conduct appropriate post-hoc or ad-hoc statistical analyses of clinical trial data and / or registry (i.e., Observational) data.  

2) Design, develop, test, implement, and document statistical programming in high-level software packages e.g. SAS.

3) Produce well documented data packages that include tables, listings, and figures.

4) Work closely with the Team Lead Biostatistician and/or Team Lead Programmer to develop and implement project QC plans, timelines and KPIs.

5) Learn, implement, and share through lecture series at least one indication of disease and product (Immunology, Multiple Sclerosis and Neurology, Rare Diseases, Rare Blood Disorders and Oncology) expertise.

6) Review appropriate biomedical and clinical research literature related to assigned project(s).

7) Active participation and Effective contributing in project governance meeting to proactively discuss risks, issues related to timelines and quality of deliverables.

8) Present your selected / assigned topic in lecture series internal and / or across line functions thereby improving the statistical knowledge and presentation skills.

9) Use Advanced analytical methods & tools to provide dashboards to the stakeholders.

Customer:

Work closely with Global Medical Affairs biostatisticians and/or programmers to identify statistical analysis needs and assist in developing assigned deliverables  

About you

Experience: Master's degree 8 years (M.Sc.) of experience required /Ph.D. in biostatistics or statistics or epidemiology (preferred) and 4 years.

Soft skills: Stakeholder management, Ability to manage timelines and Ability to work independently and within a team environment, High proficiency in statistical methods used in the pharmaceutical industry, Autonomy in the management of activities; ability to manage multiple conflicting high priority deadlines.

Technical skills: Advance SAS programming skills, SDTM & ADaM (CDISC) and other statistical computing software skills in a clinical data environment across multiple therapeutic areas.

Education: Master of Science degree or equivalent in Statistics/ Ph.D. in biostatistics or statistics or epidemiology

Languages: Excellent English language knowledge – written and spoken

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, disability, or gender identity.

Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com!

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!