Principal Biostatistician - Clinical Statistics

About the job

As a Principal Biostatistician, youll Lead or support one or several early/late phase studies, under minimum supervision of statistical team leader.We are an innovative global healthcare company with one purpose: to chase the miracles of science to improve peoples lives. Were 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.

Main responsibilities:

• Support the clinical study design (including protocol development), the study setup and conduct.
• Conduct 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.
• 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
• 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
• 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: Experience in pharmaceutical or related industry experience with clinical trials
• Soft and technical skills: Demonstrated interpersonal and communicationskills
• Good knowledge and good understanding of statistical concepts and techniques
• Good knowledge of pharmaceutical clinical development
• Able to work in departmental computing environment, can do advanced statistical analyses using SAS, R and other languages.
• Education: MS or PhD in Statistics or relevant fields
• Languages: Excellent 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 its through a promotion or lateral move, at home or internationally.Enjoy a thought
• 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.