Isomorphic Labs
Team Leader / Research Leader (Computational Drug Design)(m/w/x)
Vollzeitnur vor OrtSenior
Lausanne
Neuer Job?Nejo!
Dein persönlicher KI-Karriere-Agent
DEDebiopharm
Head of Biostatistics & Data Management(m/w/x)
Lausanne
VollzeitVor OrtSenior
Nejo KI-Zusammenfassung
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.
Anforderungen
- 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
Aufgaben
- 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
Berufserfahrung
- 12 Jahre
Ausbildung
- Doktor / Ph.D.
Sprachen
- Englisch – verhandlungssicher
Tools & Technologien
- R
- SAS
Benefits
Sonstige Vorteile
- Equal-Pay certified workplace
Lockere Unternehmenskultur
- Inclusive and respectful workplace
Sinnstiftende Arbeit
- Culture that values people, purpose, and performance
Startup-Atmosphäre
- Chance to grow, share, and shape the future of healthcare
Die Originalanzeige dieses Stellenangebotes in der aktuellsten Version findest du hier. Nejo hat diesen Job automatisch von der Website des Unternehmens Debiopharm erfasst und die Informationen auf Nejo mit Hilfe von KI für dich aufbereitet. Trotz sorgfältiger Analyse können einzelne Informationen unvollständig oder ungenau sein. Bitte prüfe immer alle Angaben in der Originalanzeige! Inhalte und Urheberrechte der Originalanzeige liegen beim ausschreibenden Unternehmen.
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DEDebiopharm
Head of Biostatistics & Data Management(m/w/x)
Lausanne
VollzeitVor OrtSenior
Nejo KI-Zusammenfassung
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.
Anforderungen
- 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
Aufgaben
- 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
Berufserfahrung
- 12 Jahre
Ausbildung
- Doktor / Ph.D.
Sprachen
- Englisch – verhandlungssicher
Tools & Technologien
- R
- SAS
Benefits
Sonstige Vorteile
- Equal-Pay certified workplace
Lockere Unternehmenskultur
- Inclusive and respectful workplace
Sinnstiftende Arbeit
- Culture that values people, purpose, and performance
Startup-Atmosphäre
- Chance to grow, share, and shape the future of healthcare
Die Originalanzeige dieses Stellenangebotes in der aktuellsten Version findest du hier. Nejo hat diesen Job automatisch von der Website des Unternehmens Debiopharm erfasst und die Informationen auf Nejo mit Hilfe von KI für dich aufbereitet. Trotz sorgfältiger Analyse können einzelne Informationen unvollständig oder ungenau sein. Bitte prüfe immer alle Angaben in der Originalanzeige! Inhalte und Urheberrechte der Originalanzeige liegen beim ausschreibenden Unternehmen.
Gefällt dir diese Stelle?
BetaDein Career Agent findet täglich ähnliche Jobs für dich.
Über das Unternehmen
Debiopharm
Branche
Pharmaceuticals
Beschreibung
Debiopharm is a privately-owned Swiss biopharmaceutical company committed to research in oncology and infectious diseases to improve patient outcomes and quality of life.
Noch nicht perfekt?
- Isomorphic Labs
Team Leader / Research Leader (Computational Drug Design)(m/w/x)
Vollzeitnur vor OrtSeniorLausanne - Debiopharm International SA
Medical Director, Oncology(m/w/x)
Vollzeitnur vor OrtBerufserfahrenLausanne - Adaptyv
Head of QC & Analytics(m/w/x)
Vollzeitnur vor OrtSeniorLausanne - Debiopharm
Senior Trial Master File (TMF) Specialist(m/w/x)
Vollzeitnur vor OrtSeniorLausanne - Debiopharm
Associate Safety Physician(m/w/x)
Vollzeitnur vor OrtBerufserfahrenLausanne