수평: Mid-Senior level

직업 종류: Full-time

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작업 내용

Debiopharmis an independent biopharmaceutical company based in Switzerland with an ongoing commitment to research in oncology and infectious diseases in order to improve patient outcomes and quality of life. Our main activities include drug development, drug manufacturing and digital health investment. Debiopharm International SA aims to develop innovative therapies that target high unmet medical needs. Our unique "development only" business model allows us to act as a bridge between disruptive discovery products and patient access in international markets. We first identify high-potential compounds for in-licensing, clinically demonstrate their safety and efficacy and then select large pharmaceutical commercialization partners to maximize patient access globally.

At Debiopharm you will be at the forefront of the fight against cancer and infectious diseases, and you will have the opportunity to work on new innovative medicines for patients. Efficiency is our mode of action, saving lives our collective target.

Here:https://apply.workable.com/debiopharm-group-sa/



Debiopharm’s Biostatistics and Data Management embraces innovative statistical science and digital solutions to bring effective drugs for unmet medical need to patients faster. We focus on innovative statistical designs to support faster PoC and maximize probability of success.

For our Biostatistics and Data Management Department (around 20 people), we are seeking a highly motivated, and collaborative

Senior/Principal Biostatistician, Clinical Development

As Global Senior/Principal Clinical Development Biostatistician, you provide expert statistical input and contributes to development plans, clinical trials design, protocol writing, statistical analysis, and interpretation of results. Your are accountable for timely availability of high-quality analysis results to support decision making. Your provide statistical oversight and guidance to study teams and outsourcing partners, and are a key member of clinical study teams and project sub-teams.

Your responsibilities will be but not limited to:

  • Provide expert statistical input to the design, analysis and interpretation of clinical studies, and development plans, primarily within Oncology
  • Ensure provision of quality and timely statistical analyses results that support quality and timely decision making
  • Lead statistical and programming study teams and perform statistical analyses
  • Provide statistical oversight and guidance to study teams and outsourcing CRO partners, ensuring CROs’ accountability for the quality of their deliverables
  • Represent statistics within cross functional study teams and project sub-teams and provide statistical support and solutions
  • Provide statistical support for briefing books, submissions, health authorities’ requests, publications, and other relevant documents, as assigned
  • Participate in interactions with health Authorities
  • Maintain current scientific and regulatory knowledge
  • Provide input/lead internal process improvement and/or new statistical capability


Requirements

  • MSc. or PhD in statistics or related field
  • At least 5 years’ experience as project/study statistician in Clinical Development in the pharmaceutical industry
  • Experience of development program design and data analysis working on Oncology studies
  • Strong statistical methodology knowledge and implementation. Experience using Bayesian designs is a plus.
  • Proven experience and programming skill in SAS or R
  • Up to date knowledge of regulatory requirements related to statistics
  • Continuous improvement mindset and looking to bring best practices
  • Effective communication and ability to build positive relationships with internal and external stakeholders
  • Team player, looking to be part and contribute to the team success


Benefits

  • International, highly dynamic environment with a long term vision.
  • Cross-functional collaboration at the forefront of the most advanced scientific developments in oncology and anti-bacterial industry
  • Exposure to a wide variety of areas and functions within clinical development and the pharmaceutical industry
  • Participation in a company where innovation, people and entrepreneurship are the fundamental keys to success.





The use of external staffing agencies or recruiters requires prior approval from our Human Resources Department. The Human Resources Department at Debiopharm requests external staffing agencies or recruiters not to contact Debiopharm employees or members of the Board of Directors directly in an attempt to present candidates.

Submission of unsolicited resumes in advance of an agreement between the Human Resources Department and the external staffing agency or recruiter does not create any implied obligation on the part of Debiopharm.

Debiopharm will not accept unsolicited resumes from any source other than candidates themselves for either current or future positions.

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마감 시간: 08-04-2024

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