Experience

University of Lucerne

• Higher Education
• 200 - 300 Employee

• Head Biostatistics and Methodology, Clinical Trial Unit – Central Switzerland

  • Apr 2017 - Present

  Head Biostatistics and Methodology Clinical Trial Unit – Central Switzerland University of Lucerne Department of Health Sciences and Medicine The Clinical Trial Unit Central Switzerland has been implemented as a cooperation of the Swiss Paraplegic Centre (in Nottwil), the Lucerne Cantonal Hospital and the University of Lucerne to establish and further develop a common institution in order to support and strengthen their existing clinical research capabilities. Consulting and… Show more Head Biostatistics and Methodology Clinical Trial Unit – Central Switzerland University of Lucerne Department of Health Sciences and Medicine The Clinical Trial Unit Central Switzerland has been implemented as a cooperation of the Swiss Paraplegic Centre (in Nottwil), the Lucerne Cantonal Hospital and the University of Lucerne to establish and further develop a common institution in order to support and strengthen their existing clinical research capabilities. Consulting and resources of the Clinical Trial Unit Central Switzerland will be available for research initiatives driven by present and future network partners as well as for externally sponsored projects. https://www.unilu.ch/en/faculties/department-of-health-sciences-and-medicine/departement-governance/dr-dirk-lehnick/ Show less Head Biostatistics and Methodology Clinical Trial Unit – Central Switzerland University of Lucerne Department of Health Sciences and Medicine The Clinical Trial Unit Central Switzerland has been implemented as a cooperation of the Swiss Paraplegic Centre (in Nottwil), the Lucerne Cantonal Hospital and the University of Lucerne to establish and further develop a common institution in order to support and strengthen their existing clinical research capabilities. Consulting and… Show more Head Biostatistics and Methodology Clinical Trial Unit – Central Switzerland University of Lucerne Department of Health Sciences and Medicine The Clinical Trial Unit Central Switzerland has been implemented as a cooperation of the Swiss Paraplegic Centre (in Nottwil), the Lucerne Cantonal Hospital and the University of Lucerne to establish and further develop a common institution in order to support and strengthen their existing clinical research capabilities. Consulting and resources of the Clinical Trial Unit Central Switzerland will be available for research initiatives driven by present and future network partners as well as for externally sponsored projects. https://www.unilu.ch/en/faculties/department-of-health-sciences-and-medicine/departement-governance/dr-dirk-lehnick/ Show less



NUVISAN The Science CRO

• Germany
• Pharmaceutical Manufacturing
• 300 - 400 Employee

• Head of Data Science / Director Biostatistics

  • May 2010 - Mar 2017

  Directing and supervising all biostatistical, pharmacokinetical and data-related operations Managing teams in Neu-Ulm (NUVISAN) and Neuss (FOCUS CDD, part of NUVISAN until DEC 2012) as well as several external service providers Project responsibility across all relevant phases (Phase I-IV) and therapeutic areas Contribution to development programmes for originators/innovators, biosimilars (special interest), generics and medical devices Evolving strategies how to… Show more Directing and supervising all biostatistical, pharmacokinetical and data-related operations Managing teams in Neu-Ulm (NUVISAN) and Neuss (FOCUS CDD, part of NUVISAN until DEC 2012) as well as several external service providers Project responsibility across all relevant phases (Phase I-IV) and therapeutic areas Contribution to development programmes for originators/innovators, biosimilars (special interest), generics and medical devices Evolving strategies how to develop the departments incl. implementation of state-of-the art processes (eClinical, EDC etc.), services (pharmacometrics, modelling and simulation, health economics etc.) and standards (CDISC, statistical programming, reporting etc.) Conducting policy training and ensure employees are working in compliance with SOPs and GCP guidelines Recognizing major departmental successes and failures and resolve accordingly Evaluating departmental capacity needs on an ongoing basis and coordinate/delegate workload efficiently and in accordance with given timelines Process control / Process improvement (Six Sigma) Representing department/functional area in Business Development, including reviewing proposals and participating in general capabilities and bid defense meetings Consulting for clients regarding development programmes, study design (incl. adaptive designs), health authorities Participation in / contribution to Scientific Advice, Steering Committee, Medical Boards, DSMB meetings Clients located in Europe, US/Canada, Japan, India, and Latin America Show less Directing and supervising all biostatistical, pharmacokinetical and data-related operations Managing teams in Neu-Ulm (NUVISAN) and Neuss (FOCUS CDD, part of NUVISAN until DEC 2012) as well as several external service providers Project responsibility across all relevant phases (Phase I-IV) and therapeutic areas Contribution to development programmes for originators/innovators, biosimilars (special interest), generics and medical devices Evolving strategies how to… Show more Directing and supervising all biostatistical, pharmacokinetical and data-related operations Managing teams in Neu-Ulm (NUVISAN) and Neuss (FOCUS CDD, part of NUVISAN until DEC 2012) as well as several external service providers Project responsibility across all relevant phases (Phase I-IV) and therapeutic areas Contribution to development programmes for originators/innovators, biosimilars (special interest), generics and medical devices Evolving strategies how to develop the departments incl. implementation of state-of-the art processes (eClinical, EDC etc.), services (pharmacometrics, modelling and simulation, health economics etc.) and standards (CDISC, statistical programming, reporting etc.) Conducting policy training and ensure employees are working in compliance with SOPs and GCP guidelines Recognizing major departmental successes and failures and resolve accordingly Evaluating departmental capacity needs on an ongoing basis and coordinate/delegate workload efficiently and in accordance with given timelines Process control / Process improvement (Six Sigma) Representing department/functional area in Business Development, including reviewing proposals and participating in general capabilities and bid defense meetings Consulting for clients regarding development programmes, study design (incl. adaptive designs), health authorities Participation in / contribution to Scientific Advice, Steering Committee, Medical Boards, DSMB meetings Clients located in Europe, US/Canada, Japan, India, and Latin America Show less



STATPROC (self-employed), Hohentengen / Germany

• Statistical Processing, Analysis and Consulting

  • Jan 2010 - Apr 2010

  Freelance / Consulting / Interim Management projects Clients in several European countries Statistical consulting and teaching Supervising and performing biostatistical and data-related activities Consulting for clients regarding development programmes, study design (incl. adaptive designs), health authorities Developing strategies and standards regarding Data Management, Analysis and Reporting, and cross-functional processes Process management, policy… Show more Freelance / Consulting / Interim Management projects Clients in several European countries Statistical consulting and teaching Supervising and performing biostatistical and data-related activities Consulting for clients regarding development programmes, study design (incl. adaptive designs), health authorities Developing strategies and standards regarding Data Management, Analysis and Reporting, and cross-functional processes Process management, policy training, auditing Steering committees, Monitoring boards Show less Freelance / Consulting / Interim Management projects Clients in several European countries Statistical consulting and teaching Supervising and performing biostatistical and data-related activities Consulting for clients regarding development programmes, study design (incl. adaptive designs), health authorities Developing strategies and standards regarding Data Management, Analysis and Reporting, and cross-functional processes Process management, policy… Show more Freelance / Consulting / Interim Management projects Clients in several European countries Statistical consulting and teaching Supervising and performing biostatistical and data-related activities Consulting for clients regarding development programmes, study design (incl. adaptive designs), health authorities Developing strategies and standards regarding Data Management, Analysis and Reporting, and cross-functional processes Process management, policy training, auditing Steering committees, Monitoring boards Show less



Medpace

• United States
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Director of Biostatistics

  • Jun 2009 - Dec 2009

  Directing all operations of designated functional area, department, geographic region, or group of employees Statistical consulting and teaching (clients and internal) Supervising for all biostatistical and data-related activities Coordinating functions and activities between departments to ensure contracts/projects awarded to Medpace are successfully completed Overseeing hiring, training, and evaluation of associates Conducting policy training and ensure… Show more Directing all operations of designated functional area, department, geographic region, or group of employees Statistical consulting and teaching (clients and internal) Supervising for all biostatistical and data-related activities Coordinating functions and activities between departments to ensure contracts/projects awarded to Medpace are successfully completed Overseeing hiring, training, and evaluation of associates Conducting policy training and ensure employees are working in compliance with SOPs and GCP guidelines Recognizing major departmental successes and failures and resolve accordingly Evaluating departmental capacity needs on an ongoing basis and coordinate/delegate workload efficiently and in accordance with given timelines Representing department/functional area in Business Development, including reviewing proposals and participating in general capabilities and bid defense meetings Maintaining Medpace departmental SOPs to ensure they are present and appropriate Since Medpace was, at this stage, no longer able to commit to its intended European growth strategy, the Zurich office has been closed by end of 2009 Show less Directing all operations of designated functional area, department, geographic region, or group of employees Statistical consulting and teaching (clients and internal) Supervising for all biostatistical and data-related activities Coordinating functions and activities between departments to ensure contracts/projects awarded to Medpace are successfully completed Overseeing hiring, training, and evaluation of associates Conducting policy training and ensure… Show more Directing all operations of designated functional area, department, geographic region, or group of employees Statistical consulting and teaching (clients and internal) Supervising for all biostatistical and data-related activities Coordinating functions and activities between departments to ensure contracts/projects awarded to Medpace are successfully completed Overseeing hiring, training, and evaluation of associates Conducting policy training and ensure employees are working in compliance with SOPs and GCP guidelines Recognizing major departmental successes and failures and resolve accordingly Evaluating departmental capacity needs on an ongoing basis and coordinate/delegate workload efficiently and in accordance with given timelines Representing department/functional area in Business Development, including reviewing proposals and participating in general capabilities and bid defense meetings Maintaining Medpace departmental SOPs to ensure they are present and appropriate Since Medpace was, at this stage, no longer able to commit to its intended European growth strategy, the Zurich office has been closed by end of 2009 Show less



AAIPharma Services Corp./ Cambridge Major Laboratories Inc (Now Part of Alcami)

• United States
• Pharmaceutical Manufacturing
• 100 - 200 Employee

• Director Biostatistics / Pharmacokinetics / Data Analysis

  • Apr 2006 - May 2009

  Global international clinical Phase II-IV trials as well as local Phase I/IIa trials (also toxicokinetic evaluation of pre-clinical trials) All major therapeutic areas incl. cardiology, CNS, oncology, diabetes, endocrinology, women’s health, gastroenterology, dermatology, medical devices Heading teams in Neu-Ulm (European HQ, Germany) and Edinburgh (Scotland / UK) Global international clinical Phase II-IV trials as well as local Phase I/IIa trials (also toxicokinetic evaluation of pre-clinical trials) All major therapeutic areas incl. cardiology, CNS, oncology, diabetes, endocrinology, women’s health, gastroenterology, dermatology, medical devices Heading teams in Neu-Ulm (European HQ, Germany) and Edinburgh (Scotland / UK)



IMFORM GmbH

• Germany
• Pharmaceutical Manufacturing

• Director Biostatistics

  • 2003 - 2006

  International clinical Phase I-IV trials across more than 20 European countries All major therapeutic areas incl. cardiology, CNS, oncology, diabetes, respiratory, rheumatology, gastroenterology, dermatology Heading teams in Darmstadt (HQ, Germany) und Prague (Czech Republic) International clinical Phase I-IV trials across more than 20 European countries All major therapeutic areas incl. cardiology, CNS, oncology, diabetes, respiratory, rheumatology, gastroenterology, dermatology Heading teams in Darmstadt (HQ, Germany) und Prague (Czech Republic)



Institute for Statistics and Econometrics, University of Goettingen

• Senior Fellow (Assistant Professor)

  • 1997 - 2003

  Lectures in various fields of Statistics, Econometrics and Mathematics Research on a huge variety of topics in Statistics, Medicine, Finance, Economics, Logistics, Quality Management (Six Sigma) and Criminology

• Scientific Asscociate

  • 1991 - 1997



University of Cooperative Education, Welfenakademie Vienenburg/Woeltingerode

• Lecturer for Statistics

  • 1997 - 2003



Prof. Dr. P. G. Lankisch, Municipal Clinic of Lueneburg

• Statistical Co-Researcher and Statistical Consulting

  • 1992 - 2003



Private University of Applied Sciences, Goettingen

• Lecturer for Statistics

  • 1997 - 1997