Senior Principal Biostatistician

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** Senior Principal Biostatistician**#
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* Location:

Barcelona*## ##
** About the job
**** Senior*
* ** Principal Biostatistician
** within our Clinical Statistics Team at Barcelona, you’ll lead several complex clinical studies (from phase I to IV)  or observational studies under minimum supervision of statistical project leader and/or team leader. ### ###
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* Main responsibilities:

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* * Support the clinical development plan (CDP), clinical study design (including protocol development and review), the study setup and conduct.
* Lead or Support submission activities such as ISS/ISE and CTD preparation & post-marketing commitment.
* Conduct / Oversee the execution of the statistical analyses according to the Statistical Analysis Plan, 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.
* Serve as a biostatistical consultant for other members of the department and staff members from other statistics department within the organization.
* Maintain knowledge and awareness of development in biostatistics and clinical trial methodology and regulatory requirements that impact on analysis.
* Accountable for all assigned statistical deliverables related to multiple complex studies or specific domains: statistical sections in protocol including sample size calculation, randomization specifications, and statistical methodology, Estimands 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.
* Coordinate with study programmer the production and Qc of statistical analyses.
* Contribute to operation process optimization and provide inputs to statistics and quality standards.
* Represent statistics team 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 experience in complex drug development
* Experience of project management and development preferred###
** Soft and technical skills**:
* Broad knowledge and excellent 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. 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.  “Shape the future of healthcare, empower clinical advancements as a visionary leader in a leading multinational pharmaceutical company”
** Pursue*
* * Progress*.
** Discover*
* * Extraordinary*.Join Sanofi and step into a new era of science - where your growth can be just as…