Clinical Statistics Team Lead

Sanofi

Barcelona, Spain

As a Clinical Statistics Team Lead within our R&D Statistics Team at Barcelona, you’ll direct/oversee statistical support of a team of senior and principal biostatisticians, be accountable for statistical aspects and deliverables of the team and responsible for appropriate resource planning and allocation.

Main 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:
- 7+ years (MS) or 5+ years (PhD) of solid pharmaceutical industry experiences;
- Experience of project/with people management and development preferred.
Soft and technical skills:
- Broad knowledge and good understanding of advanced statistical concepts and techniques;
- Demonstrated strong project/study management, interpersonal and communication skills;
- Good knowledge of pharmaceutical clinical development, together with early, late phase and post-marketing experiences;
- Extensive ability to apply advanced statistical analyses using SAS and R languages;
- Knowledge or experience with Artificial intelligence or Generative AI is a plus.
Education: MS or PhD degree in Statistics or relevant fields;
Languages: Highly effective communication in English, both oral and written.