Isomorphic Labs
Team Leader / Research Leader (Computational Drug Design)(m/w/x)
Full-timeOn-siteSenior
Lausanne
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DEDebiopharm
Head of Biostatistics & Data Management(m/w/x)
Lausanne
Full-timeOn-siteSenior
Nejo AI Summary
Leading biostatistics and data management for oncology and infectious disease treatments. 8+ years leading teams and clinical trial expertise required. Equal-pay certified, inclusive workplace.
Requirements
- Ph.D. in Statistics, Biostatistics, Mathematics, or related field
- Minimum 12 years biotech/pharmaceutical industry experience
- At least 8 years leading Biostatistics, Statistical Programming, Data Management
- Expertise in clinical/pharmaceutical trial planning and conduct
- Early phase clinical development oncology studies experience preferred
- Expertise in statistical design, planning, analysis, reporting
- Extensive knowledge of GCP, ICH guidelines, FDA/EMA regulations
- Proven experience with eCTD NDA submissions
- Hands-on knowledge of R, SAS necessary
- Strong appetite for Innovation, Digitalization, AI
- Hands-on experience with Innovation, Digitalization, AI an asset
- Exceptional leadership, communication, interpersonal skills
- Ability to thrive in cross-functional, matrix environment
- High motivation and results-oriented mindset
- Ability to work in quickly changing environment
- Excellent verbal and written English communication skills
- Doctorate education
- Director level experience
Tasks
- Lead and motivate the Biostatistics and Data Management team
- Mentor statisticians, data managers, and statistical programmers
- Oversee collaborations with CROs and external vendors
- Drive organizational and talent development
- Plan and secure resources for short and long-term goals
- Guide statistical design methodology across programs
- Contribute to clinical development plans, trial protocols, SAPs, and CSRs
- Develop and implement innovative statistical models and methods
- Stay current with state-of-the-art practices and global regulatory guidance
- Perform project statistician duties when required
- Provide input on study design, endpoints, and sample size calculation
- Review Case Report Forms
- Ensure statistical components of Clinical Trial Reports for regulatory submissions
- Supervise and contribute to regulatory strategy and submission documents
- Prepare Briefing Books, NDA/CTD, and responses to regulatory agencies
- Ensure compliance with FDA, EMA, ICH, and CDISC guidelines
- Partner with Clinical Development, Clinical Operations, Regulatory Affairs, and Translational Medicine
- Shape study protocols and ensure data integrity
- Prepare oral and written reports to communicate clinical trial results
- Collaborate with Digital & IT to evolve and maintain digital platforms
Work Experience
- 12 years
Education
- Doctoral / PhD
Languages
- English – Business Fluent
Tools & Technologies
- R
- SAS
Benefits
Other Benefits
- Equal-Pay certified workplace
Informal Culture
- Inclusive and respectful workplace
Purpose-Driven Work
- Culture that values people, purpose, and performance
Startup Environment
- Chance to grow, share, and shape the future of healthcare
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of Debiopharm and processed the information on Nejo with the help of AI for you. Despite careful analysis, some information may be incomplete or inaccurate. Please always verify all details in the original posting! Content and copyrights of the original posting belong to the advertising company.
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DEDebiopharm
Head of Biostatistics & Data Management(m/w/x)
Lausanne
Full-timeOn-siteSenior
Nejo AI Summary
Leading biostatistics and data management for oncology and infectious disease treatments. 8+ years leading teams and clinical trial expertise required. Equal-pay certified, inclusive workplace.
Requirements
- Ph.D. in Statistics, Biostatistics, Mathematics, or related field
- Minimum 12 years biotech/pharmaceutical industry experience
- At least 8 years leading Biostatistics, Statistical Programming, Data Management
- Expertise in clinical/pharmaceutical trial planning and conduct
- Early phase clinical development oncology studies experience preferred
- Expertise in statistical design, planning, analysis, reporting
- Extensive knowledge of GCP, ICH guidelines, FDA/EMA regulations
- Proven experience with eCTD NDA submissions
- Hands-on knowledge of R, SAS necessary
- Strong appetite for Innovation, Digitalization, AI
- Hands-on experience with Innovation, Digitalization, AI an asset
- Exceptional leadership, communication, interpersonal skills
- Ability to thrive in cross-functional, matrix environment
- High motivation and results-oriented mindset
- Ability to work in quickly changing environment
- Excellent verbal and written English communication skills
- Doctorate education
- Director level experience
Tasks
- Lead and motivate the Biostatistics and Data Management team
- Mentor statisticians, data managers, and statistical programmers
- Oversee collaborations with CROs and external vendors
- Drive organizational and talent development
- Plan and secure resources for short and long-term goals
- Guide statistical design methodology across programs
- Contribute to clinical development plans, trial protocols, SAPs, and CSRs
- Develop and implement innovative statistical models and methods
- Stay current with state-of-the-art practices and global regulatory guidance
- Perform project statistician duties when required
- Provide input on study design, endpoints, and sample size calculation
- Review Case Report Forms
- Ensure statistical components of Clinical Trial Reports for regulatory submissions
- Supervise and contribute to regulatory strategy and submission documents
- Prepare Briefing Books, NDA/CTD, and responses to regulatory agencies
- Ensure compliance with FDA, EMA, ICH, and CDISC guidelines
- Partner with Clinical Development, Clinical Operations, Regulatory Affairs, and Translational Medicine
- Shape study protocols and ensure data integrity
- Prepare oral and written reports to communicate clinical trial results
- Collaborate with Digital & IT to evolve and maintain digital platforms
Work Experience
- 12 years
Education
- Doctoral / PhD
Languages
- English – Business Fluent
Tools & Technologies
- R
- SAS
Benefits
Other Benefits
- Equal-Pay certified workplace
Informal Culture
- Inclusive and respectful workplace
Purpose-Driven Work
- Culture that values people, purpose, and performance
Startup Environment
- Chance to grow, share, and shape the future of healthcare
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of Debiopharm and processed the information on Nejo with the help of AI for you. Despite careful analysis, some information may be incomplete or inaccurate. Please always verify all details in the original posting! Content and copyrights of the original posting belong to the advertising company.
About the Company
Debiopharm
Industry
Pharmaceuticals
Description
Debiopharm is a privately-owned Swiss biopharmaceutical company committed to research in oncology and infectious diseases to improve patient outcomes and quality of life.
Not a perfect match?
- Isomorphic Labs
Team Leader / Research Leader (Computational Drug Design)(m/w/x)
Full-timeOn-siteSeniorLausanne - Adaptyv
Head of QC & Analytics(m/w/x)
Full-timeOn-siteSeniorLausanne - Debiopharm International SA
Medical Director, Oncology(m/w/x)
Full-timeOn-siteExperiencedLausanne - Debiopharm
Associate Safety Physician(m/w/x)
Full-timeOn-siteExperiencedLausanne - Société des Produits Nestlé S.A.
Sr Specialist Scientific Data Engineering(m/w/x)
Full-timeOn-siteSeniorLausanne