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Current Experience

  • Head Clinical & Scientific Affairs
    Since April 2016

Past Experience

  • Global Head Biostatistics & Clinical Submission Management
    March 2013 --- March 2016
    Defining the strategic statistical direction of all Sandoz Biopharmaceuticals development programs. Leading a team that provides biostatistics contributions to all programs as well as planning and coordination of regulatory submissions. Influencing the environment by attending Health Authority meetings and workshops to identify opportunities to foster and drive the full integration of modern aspects of drug development including model-based approaches and innovative statistical methodologies.

  • Head Clinical Operations & Biostatistics
    May 2011 --- February 2013
    Supervision of all clinical operations, data management, statistics, and medical writing activities within the Biopharmaceuticals Clinical Development Department, covering all aspects from pre-clinical studies to late phase programs Strategic input into development plans, Health Authority interactions, and development of biosimilar guidelines Oversight of outsourcing activities and coordination of CRO governance structures Line management of 30 internal associates as well as of third-party personnel

  • Head Biostatistics & Medical Science
    January 2010 --- April 2011

  • Head Biostatistics
    April 2006 --- December 2009
    Statistical management of all pre-clinical and clinical trials (Phase I, III, IV, post-marketing) conducted by the company for the development of biosimilars, including design, sample size calculation, data cleaning process, analysis and reporting Support of analytical lab for assay validation and review of lab results Coordination und supervision of the data management and statistics tasks conducted by the CRO Additional exploratory analyses, including meta-analyses, and compilation of the data and of the results for international authorities Participation in Scientific Advice meetings with EMA and FDA as well as interactions with the WHO for the development of biosimilar guidelines Development of data management and biostatistics SOPs

  • Biostatistician and Project Manager
    November 2002 --- March 2006
    Complete project management of two large Phase III trials for the development of a biosimilar epoetin as well as of various bioequivalence trials with a large variety of substances Statistical management of all Phase I / Phase III clinical trials conducted by the company, including design, sample size calculation, data cleaning process, analysis and reporting Writing the statistical parts of the study protocol and the statistical analysis plan Coordination und supervision of the data management and statistics activities conducted by CROs Additional exploratory analyses, including meta-analyses, and compilation of data and results for international authorities Development of SOPs for data management and statistics Programming of various Access databases for the management of clinical trials, budget planning within the department, and for investigator payments

  • Head Biometrics & Data Management
    August 2001 --- September 2002
    (Statistical) Design and planning of clinical trials (Phase I – III) Composition or review of the statistical part of the study protocol as well as of the statistical analysis plan, and the integrated study report Organization and review of the data management and the statistical analyses and reports provided by the CROs Additional exploratory analyses and compilation of the data and of the results for international authorities Composition of draft publications for journals and conferences

  • Biostatistician and Project Manager
    January 2000 --- July 2001
    Project manager for various clinical trials and post-marketing surveillance studies Supervision and coordination of data entry, data management, and statistics Statistical Analysis of phase III/IV clinical trials and post-marketing surveillance studies including statistical input to the study design, sample size calculations, CRF design, and compilation of the statistical analysis plan Presentation of the results at the sponsor’s site Budgeting and preparation of offers to sponsors

  • BioStatistician
    July 1998 --- December 1999


Self Assessment :
Analytical thinkingCreative thinkingInterest in knowledgeOptimismProactivityProblem solvingResult OrientedStrategic thinking


Self Assessment :
BiostatisticsBiopharmaceuticalsCDISCClinical Data Management (CDM)Clinical DevelopmentClinical trialsCross-functional team leadershipFDAGood Clinical Practice (GCP)ICH guidelinesMedical writingpeople managementPharmacodynamicsPharmacokineticsRegulatory affairsRegulatory submissionsSASBiosimilarsEMAPMDA

Skills and Expertise

Self Assessment :
Develop clinical trial protocols Interpret dataCoach and provide guidance to clinical staff.Communicate effectively on different company levelsConduct limited data and/or statistical analysis.Successful presentation and negotiation with Health AuthoritiesExtensive expertise in Biosimilar development


  • PhD in Mathematik/Statistik from University of Wisconsin-Milwaukee in 1998
  • Diploma in Business Mathematics from University Ulm, Germany in 1994


BrightOwl Assessment:
Self Assessment:
Full Proficiency
Elementary Proficiency

Work Preferences

  • Notice Period:
    12 weeks
  • Positions I am interested in:
    Head Clinical Development Head Regulatory Affairs Head Scientific Affairs
  • Locations I am interested in:
    Austria Bavaria, Germany Switzerland USA
  • Work From Home:
  • Work Regime:
    Permanent position :    80 - 100% FTE
  • International:


    Expert has 8 publications (Will be avalible with full profile)

Area / Region

Bavaria, Germany


Driving License
  • Yes