Biostatisticien Ps2 H / F

Servier; Saclay; Sur place; EUR 55 000 - 75 000; Plein temps

Résumé du poste

A leading pharmaceutical company in France seeks an experienced Senior Biostatistician to drive and oversee projects related to clinical studies. The ideal candidate will have a Master's or Doctorate in Biostatistics, 5 years of experience in clinical statistics, and be proficient in SAS and R. Responsibilities include ensuring state-of-the-art methodologies, developing statistical plans, and collaborating with various teams. This role offers an opportunity to impact therapeutic progress positively.

Qualifications

• 5 years experience as clinical statistician supporting clinical trials.
• Strong experience in innovative statistical concepts.
• Mastery of regulatory guidelines (FDA, EMEA, ICH).
• Ability to communicate effectively with project teams.

Responsabilités

• Collaborate in preparing the clinical study protocol.
• Support clinical trial objectives using modeling and simulation.
• Develop and implement new statistical methodologies.
• Ensure validation of statistical results and reports.

Connaissances

Clinical trial support

Innovative statistical concepts

Regulatory guidelines mastery

SAS expertise

R expertise

Interpersonal communication

Detail-oriented

Team collaboration

Fluent in English

Formation

Master or Doctoral degree in Biostatistics or Statistics

Description du poste

As a senior biostatistician you join an international and committed team, in charge of methodological and statistical approaches serving our clinical studies and supporting related development plans.

You drive the projects and studies you are assigned, ensuring state-of-the-art methodologies and deliverables, in compliance with regulatory guidelines as well as all Servier policies and procedures.

Missions

• Collaborates in the preparation of the clinical study protocol : methodological choices (experimental design, randomisation, etc.), statistical estimation of the number of patients and statistical analysis strategy.
• Support clinical trial objectives to optimize the study design using modelling and simulation.
• Develop, implement or advise on appropriate new statistical methodologies and keep abreast of current issues and developments in statistical theory and applications.
• Ensures study data statistical analysis :
• Writes the Statistical Analysis Plan (SAP), the table / listings / graph document (TLG) and the summary for the clinical report,
• Manage the development of statistical outputs and documents with programming team
• Ensures validation of the results produced and their validity and robustness,
• Participates in internal communication of results,
• Validates the draft clinical report and ensures proper statistical interpretation of the results within the scope of the clinical report and scientific publications.
• Contribute to productive collaborations with other stakeholders, promoting teamwork, quality, operational efficiency and innovation
• Statistical support to regulatory filing documents, as well as to the responses to the agencies, in collaboration with the development and regulatory teams, and potential external experts.
• Lead or participate in working groups on methodological and statistical issues, as well as in transversal and multidisciplinary projects
• Contribute to the internal and external visibility of the department and promote the development of internal scientific knowledge.

Profile

Master or Doctoral degree or equivalents in Biostatistics, Statistics or closely related fileds.

You demonstrate :

• 5 years experience as clinical statistician supporting clincial trials
• Strong experience and in-depth knowledge of innovative statistical concepts and methods
• Mastery of regulatory guidelines (FDA, EMEA, ICH)
• SAS and R expertise
• Ability to effectively communicate with others on the project team and in the department; strong interpersonal communication skills
• Detail oriented, well organized with the ability to work on several projects simultaneously
• Excellent team player, collaborative and maintains a positive, results-orientated work environment
• English fluency is required

Nous sommes engagés pour l'égalité des chances et le développement des talents dans toute leur diversité. Nous accordons autant de valeur à l'expérience qu'à l'envie de s'engager au quotidien pour être utile au progrès thérapeutique au bénéfice des patients. Si vous vous reconnaissez dans cette offre et ces quelques lignes, saisissez cette opportunité de nous rencontrer.