Experience

Novaremed AG

• Switzerland
• Biotechnology
• 1 - 100 Employee

• Head of Biometry

  • Jan 2018 - Present



AbaNovus

• Italy
• Pharmaceutical Manufacturing

• CEO and Expert Consultant

  • Dec 2010 - Present

  Maurizio Rainisio’s domains of competence:Methodology and statistics for clinical studies and clinical surveys His experience spans through multiple therapeutic areas and includes all phases of clinical development. He has contributed to the planning, development, approval, and post-marketing of successful projects for methodological and statistical aspects including extensive interactions with health authorities at all levels. Although only from the side of the sponsoring company, he has extensive experience of Data Monitoring Committees (DMC/DSMB) rationale and operations, including the statistical/data management support services.Clinical Data Management Innovative clinical data management systems for Hoffmann La Roche and Actelion, which have been in production for very long periods of time, have been implemented under his supervision. He has extended experience in WEB-based Endpoint Assessment Committees (EAC); one of the first implementations having been developed under his supervision in the late 90’s.Management and organization.He has successfully led very cohesive teams of statisticians, programmers and data managers, who have always delivered proven outstanding performance.He supervised the development of full quality management systems for the functions under his supervision and for their interactions with other clinical development functions.



Actelion

• Switzerland
• Research Services

• VP, Head of Global Biometry

  • Jan 2001 - Nov 2010

  Globally responsible of Biostatistics, Clinical Datamanagement (including Systems Development). Member of the Clinical Development Management Team. Globally responsible of Biostatistics, Clinical Datamanagement (including Systems Development). Member of the Clinical Development Management Team.



Statistics for Research Ltd

• Partner

  • Jul 1984 - Jan 2001

  Responsible of a group of professionals providing expert advise and services in the fields of Medical Statistics and Clinical Data Management Responsible of a group of professionals providing expert advise and services in the fields of Medical Statistics and Clinical Data Management



ASC Srl

• Partner

  • Jan 1983 - Jun 1984

  Providing expert advise and services in the fields of Medical Statistics and Clinical Data Management Providing expert advise and services in the fields of Medical Statistics and Clinical Data Management



Ciba-Geigy Ltd

• Statistician

  • Dec 1978 - Dec 1982

  Project statistician.Leader of the Mathematical Statistics group Project statistician.Leader of the Mathematical Statistics group



University of Milan

• Medical Practices
• 1 - 100 Employee

• Grant

  • Jan 1975 - Dec 1978

  Research work at 'Istituto di Biometria' on a CNR grant Research work at 'Istituto di Biometria' on a CNR grant