At Shire, we are proud and grateful to employ military veterans and thank them for their contributions to our company and our country. See where your military experience can play a role at Shire by using our military skills translator job search tool below:
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
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 (https://www.youtube.com/watch?v=SkpDBZ-CJKw&t=67s) and check out our Diversity Equity and Inclusion actions at sanofi.com (https://www.sanofi.com/en/our-responsibility/equality-and-inclusiveness) !
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 (https://youtu.be/96EwNjb1TLo)
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 (http://www.youtube.com/watch?v=SkpDBZ-CJKw&t=2s)