Clinical Statistics Team Lead

Job title: Clinical Statistics Team Lead

• Location:IN / Hyderabad
  

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 Clinical Statistics Team Lead within our Statistics Team, you’ll Directly/oversee statistical support of a team of senior and principal biostatisticians. Accountable for statistical aspects and deliverables of the team. Responsible for appropriate resource planning and allocation.

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?

Major Responsibilities:

• Support the clinical development plan (CDP), the clinical study design (including protocol development), study setup and conduct.

• Oversee the execution of the statistical analyses according to the SAP and ISAP, prepare statistical methods & provide statistical insight into interpretation and discussion of results sections for the clinical study report (CSR) and/or publications to ensure the statistical integrity of the content according to internal standards and regulatory guidelines and in compliance with SOPs.

• Accountable for all assigned statistical deliverables related to one study or specific domain: statistical sections in protocol including sample size calculation, randomization specifications, and statistical methodology etc., SAP, data surveillance, statistical analysis results for CSR and its appendices (TLGs and in-text tables) …

• Propose, prepare and perform exploratory data analyses, ad-hoc analyses as relevant for the study or project objectives. Contribute to define and review the specific deliverables related to Transparency and Disclosure. Oversee the study data specifications, the production of the statistical analyses and the quality control coordinating with the programming team lead.

• Plan and track project/study activities and timelines. Contribute to operation process optimization and provide inputs to statistics and quality standards. Define team priorities and goals, conduct performance review and assist in problem solving. Define the development plan and conduct the continuous trainings for junior staff.

• Ensure productive collaborations with other functions in the aligned study team and/or safety monitoring team and in communicating with senior leadership.; Promoting teamwork, quality, operational efficiency, and innovation. Represent statistics to participate in scientific or technology working groups or cross function initiatives

About you

• Experience: Solid pharmaceutical industry experiences.

• Soft skills: Experience of project/with people management and development preferred.

• Demonstrated strong project/study management, interpersonal and communication skills.

• Broad knowledge and good understanding of advanced statistical concepts and techniques

• Good knowledge of pharmaceutical clinical development, together with early, late phase and post-marketing experiences

• Knowledge or experience with Artificial intelligence or Generative AI is a plus

• Technical skills: Extensive ability to apply advanced statistical analyses using SAS and R languages.

• Education: MS or PhD degree in Statistics or relevant fields

• Languages: Highly effective communication in English, both oral and written.

Why choose us?

• Bring the miracles of science to life alongside a supportive, future-focused team.

• Discover endless opportunities to grow your talent and drive your career, whether it’s through a promotion or lateral move, at home or internationally.

• Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact.

• Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs and at least 14 weeks’ gender-neutral parental leave.

• Build, develop and manage a statistics team support multiple TAs and different clinical phases

• Develop a career of being an influential statistician

• Gain international clinical trial experiences and communicate with Health Authorities worldwide