Associate Director Biostatistics Biosimilar

Associate Director Biostatistics Biosimilar

Sandoz

Holzkirchen, Germany

Your responsibilities:

  • Act as Program statistician for several biosimilar development programs within cross-functional global development teams;
  • Provide scientific, strategic and statistical input to clinical development strategies and trial designs for biosimilar development programs (including Biomarker, PK, PK/PD and efficacy/safety studies);
  • Champion, drive and implement innovative efficient trial designs and novel statistical methods within programs;
  • Independently lead interactions with Health Authorities (e.g. EMA, FDA, PMDA, NMPA) and key opinion leaders;
  • Lead planning and execution of innovative statistical analyses and eCTD preparation for regulatory submission and post-marketing activities including publications;
  • Be responsible for Sponsor oversight of trial-related activities performed by CROs/external partners;
  • Establish and maintain collaborative working relationships and effective communication within Biostatistics department, Sandoz BCD, Global Program Teams, as well as with Novartis Advanced Methodology, Novartis CD&A;
  • Explain statistical concepts in an easily understandable way to non-statisticians and provide relevant statistical interpretation and justification of analysis results;
  • Contribute to Due Diligence assessments for new product candidates;
  • Represent Sandoz in statistical forums/presentations/discussions at external congresses, conferences or scientific meetings.

Minimum requirements:

What you’ll bring to the role:

  • PhD, PharmD or MS with honors in biometrics, statistics, mathematics, pharmacometrics, clinical pharmacology, or other quantitative discipline preferred;
  • PhD with 6+ years’ experience preferred OR MS with 10+ years’ experience;
  • Extensive knowledge and evidence of hands-on experience in at least 3 of the following key areas in industry and/or academia:
    • Design of clinical development programs (including Biomarker, PK, PK/PD and efficacy/safety studies);
    • Clinical efficacy equivalence trials;
    • Adaptive designs and clinical trial simulation;
    • Application of clinical pharmacology and/or pharmacometrics methods;
    • Bayesian trial design and analysis;
    • Advanced statistical modelling (e.g. evaluation of separate treatment effects in combination treatment regimens);
    • Application of Real World Evidence and machine learning in clinical trials.
  • Proficiency in use of statistical software packages (e.g. SAS, R);
  • Clinical, pharmacological and therapeutic knowledge;
  • Good interpersonal and communication skills (verbal and writing) to bridge scientific and business needs, integrating quantitative sciences.

Apply Now

Don't forget to mention EuroPharmaJobs when applying.

Share this Job

More Job Searches

Germany     Bioinformatics     Data, Programming and Statistics     Manager and Executive     Programming     Statistics     Sandoz    

© EuroJobsites 2021

EuroJobsites is a registered company number: 4694396 VAT number: GB 880 9055 04

Registered address: EuroJobsites Ltd, Unit 8, Kingsmill Business Park, Kingston Upon Thames, London, KT1 3GZ, United Kingdom

Newsletter | Recruit | Advertise | Privacy | Contact Us

© EuroJobsites 2021

EuroJobsites is a registered company number: 4694396 VAT number: GB 880 9055 04

Registered address: EuroJobsites Ltd, Unit 8, Kingsmill Business Park, Kingston Upon Thames, London, KT1 3GZ, United Kingdom

This website uses cookies to make your experience better. Continued use of this website means you accept our cookie policy.  Accept Cookies