Associate Statistical Project Leader, Biostatistics (all genders)

About the job

Our Team:

At Sanofi, we have a shared commitment to bring innovation and rigor to oncology clinical development. As Associate Statistical Project Leader, you will lead several oncology early phase projects or late phase studies under minimum supervision of statistical project leader and/or team leader. You will be supported by a Biostatistics Department that invests in the development of all our team members, offering compelling career opportunities that value diversity of thought and abilities, to optimize overall success and have a meaningful impact on patients’ lives.

Main responsibilities:

Provide support to the clinical trial study and/or project team on all relevant statistical matters under the supervision of senior statistical project leader or team leader:

• Provide high quality input into the design of the clinical study (including protocol development), the setup and conduct of the study to make sure data are adequately captured and collected to answer the study objectives and to support the planned statistical analyses.
• Accountable for all statistical deliverables related to the study: statistical sections in protocol including sample size calculation, randomization specifications, and statistical methodology, etc., Statistical Analysis plan, data surveillance, statistical analysis results for CSR and its appendices (TLGs and in-text tables).
• Accountable for statistical aspects of clinical development plan.
• Effectively utilize external groups, e.g. CROs or data monitoring committees (DMC).
• Work with the programming team to provide definitions, documentation and review of derived variables, as well as the quality control plan.
• Perform and/or coordinate with study programmer the production of statistical analyses. Review and examine statistical data distributions/properties.
• Oversee execution of the statistical analyses according to the SAP, 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.
• Propose, prepare and perform exploratory data analyses, ad-hoc analyses as relevant for the study or project objectives.
• Review submission documents, such as IND, NDA, BLA, CTE or CTD to ensure statistical validity and accuracy.
• Contribute to define and review the specific deliverables related to Transparency and Disclosure.
• Provide technical guidance to junior staff.
• Plan and track study/project activities and timelines.
• Ensure productive collaborations with other functions in the aligned study team, promoting teamwork, quality, operational efficiency, and innovation.
• Represent statistics to participate in scientific or technology working groups or cross function initiatives; Contribute to operation process optimization and provide inputs to statistics standards.

About you

• PhD/MS in statistics or related discipline with proven hands-on experience of generating (not only review and comment on) statistical deliverables in pharmaceutical industry of several clinical studies in early or late phase of development (3-5 clinical studies or 3-years of experience).
• Good knowledge of pharmaceutical clinical development, together with late phase and/or early phase experience.
• Broad knowledge and good understanding of advanced statistical concepts and techniques.
• Able to work in departmental computing environment, can do advanced statistical analyses using SAS and possibly other languages (e.g., R).
• Demonstrated strong interpersonal and communication skills.
• Working experience in clinical development such as clinical plan development, strategic discussion of regulatory path, interactions with regulatory agencies or other external stakeholders

Why choose us?

• Are you ready to shape the future of medicine? The race is on to speed up drug discovery and development to find answers for patients and their families. Your skills could be critical in helping our teams accelerate progress. Join our Oncology Biostatistics team and you’ll assure the state-of-the-art clinical study design and analysis of Sanofi components and products, while enjoying lots of opportunities to broaden your experience and hone your skills.
• 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.
• Benefit from a well-thought-out benefits package that rewards your contribution and commitment.
• We take care of you and your family with a wide range of health and social such as high-quality healthcare, numerous prevention programs and coverage for long-term illness. Our 14-week paid family leave for both parents is outstanding as well as a wide range of childcare benefits.
• Start your career at an attractive location in the center or in the capital of Germany and experience our modern working environment and benefit from hybrid, flexible working time models.

Pursue Progress. Discover Extraordinary.

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. You can be one of those people. Chasing change, embracing new ideas and exploring all the opportunities we have to offer. Let’s pursue progress. And let’s discover extraordinary together.

At Sanofi, we provide equal opportunities to all regardless of race, color, 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!

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