Principal Biostatistician (M/F)
- Galderma Pharma S.A.
- Date de publication
Principal Biostatistician (M/F)( Job Number: 170009UC) Description Nestlé Skin Health is a global leader in improving the quality of life by delivering innovative medical solutions for the health of skin, hair and nails throughout people's lives. Nestle Skin Health aims to meet the needs of healthcare professionals and consumers through constant innovation in technology and products to protect and improve the health of the skin and treat skin diseases. Nestlé Skin Health is a subsidiary of Nestlé. For our Global SIG Rx organisation, we are currently looking for: Principal Biostatistician (M/F) Based in the Lausanne region of Switzerland, in an innovative and dynamic environment, you will be attached to the Head of Statistics: Responsible for providing statistical input and support to ensure statistical components are accurately specified and conducted; and to ensure achievement of statistical deliverables with high efficiency and quality prepared on time for Rx SIG projects. Activities and responsibilities : - Serve as biostatistics leader for a particular therapeutic indication of a project. - Provide statistical oversight of all study protocols within the same therapeutic indication to ensure consistency in statistical methods applied and to adopt flexibility in regional specific studies within the same indication. - Be the first point of contact for the statistics department within the same therapeutic indication. - Provide exhaustive review of historical data to set appropriate assumptions for efficacy. - Provide sample size and design proposals for Clinical Trial Outline (CTO) to Statistics management. - Attend Outline Review Committee (ORC) meetings as needed. - Oversee protocol development within the same therapeutic indication including but not limited to statistical aspects in the design and analysis of clinical trials. - Participate in PRC (Protocol Review Committee meeting) meetings as needed. - Biostatistics project management including but not limited to vendor management, directing statistical programming, mentoring study level statisticians, update statistics management of project status on a regular basis, and escalate issues in a timely manner. - May function as study level statistician if needed. - Ensure high quality, timely delivery of tables/listings and statistical reports. - Execute quality assurance procedures on work produced by others, ensuring statistical analysis is being done according to specifications. - Provide support for publication. - Interact with Regulatory Agencies on statistical issues and provide solutions to the best interest of Galderma. - Author or review statistical SOPs and Working Instructions. - Keep up-to-date with the latest statistical methods development related to clinical trials. - Attend statistical workshops or seminars. - Give statistical presentations. Specific technical competencies of the position: - Must be able to perform sample size estimation, statistical analysis section for the protocol, SAP, statistical programming independently. - Must be able to develop ISS and ISE to support NDA. - Must have basic knowledge of database system. Specific duties and responsibilities of the position: - All phase 2 and 3 studies initiated and sponsored by Galderma. - Phase 1 or 4 studies initiated and sponsored by Galderma as needed. Expected qualifications : - PH.D or Master’s degree in Biostatistics or applied mathematics. - Proficiency in statistical programming using SAS and other statistical softwares. - Experience in providing vendor oversight. - Good presentation skills. - Ability to present to management or a group to clearly communicate statistical thinking and ideas. - Ability to persuade or convince your position in study design strategy. - Minimum of 10+ years of industry experience as a Biostatistician in clinical trials. - Minimum of 6 years of SAS programming experience. - Regulatory interaction experience (pre-NDA , End-of-Phase 2, SPA, Adcom, Audit). - Minimum of 3 years of documented regulatory submission support experience (ISE/ISS SAP, submission dossier review, briefing package review, responses to inquiries, etc). Location: Lausanne Region, Switzerland. Date: As of Q2 2018 Primary Location : Switzerland-VD-Lausanne Job : Research/Development Organization : Galderma Schedule : Full-time Job Posting : Mar 28, 2018, 9:32:54 AM