Priya Mukherjee at CK Clinical is currently recruiting for a Project Biostatistician for an global pharmaceutical company based in the EU.
As Project Biostatistician you will take on the role of an independent Clinical Development Program Statistician for the assigned trial worldwide. In addition, you will be responsible for the supervision of other Statisticians involved with the project.
Further responsibilities of this Project Biostatistician role include:
- Provides consultation and advice in quantitative/statistical, experimental design, and data management issues. Works with the clinical monitor and international teams to develop clinical protocols, analysis plans and final study reports for clinical development projects. You will also plan, coordinate, and produce statistical analyses and summaries in support of product development.
- Member of core clinical cluster team, attend meetings as and coordinates activities with internal data management and programming staff, medical writing and regulatory affairs.
- Be the statistical leader and project manager for all deliverables globally for a clinical development program
- Ensure that clinical development program (or parts assigned) meets scientific, regulatory, quality, and commercialization requirements.
- Perform matrix management of project team, and mentor staff as required.
- Plan and track project level activities, including resources.
- Establish and maintain project standards (master analysis plan, full development project specifications).
- Plan and manage submission activities.
- Interact with Clinical Data Management as appropriate.
- Interact with Health Authorities and external consultants as appropriate. Support and defend analyses and their interpretation at Health Authority Meetings. Represent Biostatistics at FDA Advisory Committee meetings.
- Coach and mentor statisticians
The ideal candidate for this Project Biostatistician will have the following skills, experience and qualifications:
- An MSc or PhD in Statistics, Biostatistics or Mathematics with proven industrial experience (pharmaceutical industry preferred).
- Sound knowledge of statistical applications to clinical trials.
- An awareness of appropriate regulations and guidance documents.
- Good SAS programming knowledge.
- Strong problem solving skills and sound statistical judgment. Technical capability to address common statistical problems arising in work.
- Attentiveness to detail.
- Strong interpersonal skills. Effective oral & written communication skills.
- Ability to effectively represent Biostatistics and Clinical Data Management in multidisciplinary meetings.
- Ability to complete complex tasks on a timely basis with minimal supervision; well organized.
- Excellent project management skills/leadership skills.
How to apply: