Principal Biostatistician, Belgium
3 dagen geleden

Description :

Principal Statistician

Location : Belgium, Beerse

Schedule : Permanent - Full Time - Office based

TalentSource Life Sciences, the division of CROMSOURCE dedicated to flexible staffing solutions, is currently seeking an experienced Principal Statistician for one of our clients, a leading international pharmaceutical company.

Responsibilities :

  • The Principal Statistician supports the design, execution, analysis, interpretation, and reporting or communication of data evidence for Pre / Early / Late Clinical Development, Research & Discovery, Medical Affairs, Real World Evidence, or Manufacturing Sciences programs for research, development, and / or marketed product needs, with minimal supervision.
  • This position supports statistical aspects of business-critical and / or regulatory commitments, provides input to program plans with limited supervision, and represents Statistics & Decision Sciences (SDS) for cross-functional and intra-departmental teams or working groups.

  • Demonstrates advanced data analytic expertise based on a foundation of statistical principles and a strong track record of applied experience leading to successful program support.
  • Is effective in the use of relevant computational tools for study, experiment, or trial research objectives. Applies high quality statistical methodology in assigned projects with demonstrated understanding of the disease / scientific / functional area and health authority acceptability.

  • Complies with organization and company standard operating procedures in timely fashion, such as training and project time accounting.
  • Understands and aligns with relevant regulatory guidance's. Contributes high quality and timely deliverables as assessed by stakeholders such as the project team, the clinical trial team, and the Statistics Area Head.

    Ensures that documents, specifications, programs, and macros are consistent and comply with project and company standards.

    Follows best practices for Data Integrity.

  • Demonstrates thorough knowledge of pharmaceutical research and development strategies and execution. Takes a lead in providing SDS support to experimental design, modeling, analysis planning, analysis execution, interpretation, and statistical communications.
  • Is accountable for execution of individual project responsibilities, including : meetings with necessary project team members, reporting activities, exploratory analyses / graphics, and additional analyses to support publications for individual clinical trials / studies / projects.

    Is an evolving leader for providing input to team in terms of optimizing study or trial designs in line with study or indication level objectives, and supports scenario simulations and sample size calculations based on relevant technical and disease / scientific / functional area knowledge.

    Requirements :

    PhD in Statistics or related field with minimum of 8-10 years of experienceBasic knowledge of SAS programming and at least some other significant statistical software (e.

    g., S-Plus, PASS) Excellent interpersonal skills, great understanding of team-culture. Demonstrate a nature of proactivity, enthusiasm, independent drive, and energetic outlook to tasks Exceptional organizational skills, work towards and meets deadlines Ability to collaborate, build strong partnerships / relationships with all stakeholders

    Our benefits when working in Belgium :

    Competitive SalaryGroup and hospitalization insuranceElectronic meal vouchersInternet reimbursementCompany Car with fuel card depending on the functionDedicated Line ManagerRegular face-to-face or phone meetings with line managerFull annual performance review processAd-hoc team events and end of year partyCareer opportunities within both our CRO departments and our TalentSource Life Sciences Unit, locally and internationallyEmployee satisfaction survey - your feedback is important for continuous improvement

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