Clinical Development, Global Senior Biostatistician (100%)

  • Debiopharm
  • Lausanne, VD, Switzerland
  • 05/06/2021
Full time Data Science Data Analytics Big Data Data Management Statistics Biostatistician

Job Description

Debiopharm is an independent biopharmaceutical company based in Switzerland with an ongoing commitment to research in oncology and bacterial infections in order to improving 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. Bridging the gap between disruptive discovery products and real-world patient reach, we 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.

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

Debiopharm International S.A. identifies high-potential compounds for in-licensing, conducts clinical development and then selects large pharmaceutical commercialization partners to maximize patient access across the globe.

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

Clinical Development, Global Senior Biostatistician (100%)

The Senior Clinical Development Biostatistician provides statistical input to the design and analysis of Global clinical studies and development plans. She/he is accountable for the quality and timelines of all statistical and programming deliverables for assigned clinical studies, including studies for which statistical activities are outsourced to CRO partners. He/she ensures timely availability of complete, accurate and consistent analysis results to support decision making. He/she is a key member of the clinical study team.

Your responsibilities will be but not limited to:

  • Provide expert statistical input to the design, analysis and interpretation of clinical studies within Oncology and/or immunology
  • Author statistical sections of protocols and statistical analysis plans
  • 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
  • Coordinate and provide statistical oversight for outsourced studies, ensuring CROs accountability for the quality of their deliverables
  • Represent statistics within cross functional project teams and provide statistical support and solutions
  • Participate in interactions with health Authorities
  • Provide mentoring and support to other statisticians
  • Maintain current scientific and regulatory knowledge
  • Provide input/lead internal process improvement
  • Ensure adherence to GCP, regulatory guidelines, standard processes and SOPs

Requirements

  • MSc. or PhD in statistics or related field
  • Minimum of 7 years’ experience as project/study statistician in Clinical Development in the pharmaceutical industry
  • Experience working on Oncology studies
  • Strong statistical methodology knowledge and implementation. Experience using Bayesian designs is a plus.
  • Proven experience in programming skill in SAS and R
  • Up to date knowledge of regulatory requirements related to statistics
  • Continuous improvement mindset and looking to bring best practices
  • Strong communication kills and the ability to build positive relationships with internal stakeholders and external vendors
  • Team player, looking to be part and contribute to the team success
  • Ability and willingness to handle special projects.
  • Demonstrate excellent written and verbal communication skills in English and French;

Benefits

  • An international and highly dynamic environment, with a long term vision.
  • The opportunity to join a successful company, at the forefront of the most advanced scientific developments in the industry and be exposed to many areas within clinical development and the pharmaceutical industry.
  • The possibility to be in a company in which innovation, people and entrepreneurship are the fundamentals of its 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