Senior Principal Biostatistician – 6764 URA
Our client is headquartered in Switzerland – a Innovation-hub of Europe – is a high-potential biopharmaceutical company, specialized in the discovery, development and commercialization of innovative small molecules, with the aim of transforming the horizon of therapeutic options is looking a Senior Principal Biostatistician for a initial 2 year contract based in Basel.
Main Responsibilities
* Provide strategic and scientific leadership and statistical solutions with a high degree of autonomy.
* Provide statistical input to regulatory submissions, responses to authorities, and briefing documents.
* Serve as statistical lead and strategic partner for one or more therapeutic areas, ensuring statistical integrity and consistency across studies.
* Provide statistical leadership and input to the development of protocols, SAPs, and CSRs.
* Lead the design, analysis, and interpretation of clinical trials along with mentorning statisticians
* Own the quality and timeliness of statistical and programming deliverables.
* Ensure compliance with regulatory standards.
* Stay current on evolving regulatory guidance and methodological advances.
* Collaborate closely with clinical science, data management, medical writing, programming and regulatory teams to drive quantitative decision making in drug development.
* Influence decisions at program level.
* Defend statistical positions in internal and external meetings, including regulatory interactions.
Qualifications and Experience
* Relevant Swiss working/residency permit and/or Swiss/EU-Citizenship required;
* Bachelors, Masters degree of Phd in mathematics, statistics, data science, or related quantitative discipline.
* Atleast 10 years of extensive knowledge and expertise gained as a statistician or data scientist within the pharmaceutical industry
* 3 years of experience in a leadership or supervisory role
* Lead or key contributor to major regulatory submissions and successful interactions with FDA, EMA, or other health authorities
* Knowledge of international clinical research regulations and requirements, pharmaceutical industry and of the scientific, clinical, and regulatory components in the drug development process
* Proficiency in R
* Strong interpersonal skills and the ability to develop good working relationships with internal colleagues and external collaborators
* Ability to independently deal with complex and difficult situations, work under pressure, and prioritize tasks
* Active participation in industry working groups, standards bodies, or peer-reviewed publications/presentations
* Excellent communication and organizational skills
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