About the job

Our Team:

Sanofi Global Hub 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 Global Hub strives to be a strategic and functional partner for tactical deliveries to Medical, HEVA, and Commercial organizations in Sanofi, globally.

Main responsibilities:

The Senior Biostatistician will work with Medical Affairs biostatisticians and/or programmers and Sanofi Global Hub biostatistics and programming personnel to implement (Develop and/or QC) statistical analysis plans(SAP), programming specifications for analysis datasets and provide QC'd data packages including tables, figures, and listings for use in publications (i.e. abstracts, posters, oral, presentations, and 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 Senior Biostatistician will ensure SOPs are followed and timelines and quality metrics are met

• 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.

• 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 Lead Biostatistician and Lead Programmer to develop and implement project QC plans and timelines. 5) Review appropriate biomedical and clinical research literature related to assigned project(s).

• Customer: 1) Work closely with Global Medical Affairs biostatisticians to identify statistical analysis needs and assist in developing assigned deliverables

• Experience: Master's degree 6 years (M.Sc.) of experience required /Ph.D. in biostatistics or statistics or epidemiology and 3 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.