Principal Statistician

Reference Number: 896065-W
Type of placement: Contract, 12 months

Introduction:

The Principal Statistician will enable optimum statistical and data management support for all clinical trials through definition of appropriate processes and supervision of external statistics and statistical programming services, and ensure timely and qualitatively excellent preparation and delivery of statistical analysis results.

Main Responsibilities:

  • Develops and maintains timely, scientifically sound, innovative and business-oriented plan for the statistical analysis and data management of clinical studies;
  • Develops, executes or supervises appropriate statistical analyses of clinical trial data;
  • Participates in the design and analysis of clinical studies;
  • Interacts on a scientific level with partners in Medical Affairs with regards to study design and analysis to ensure that all studies are fit for purpose;
  • Ensures that members of the project teams and management have a sufficient understanding of the methods applied and the results observed and/or inference drawn;
  • Responsible for the statistical components of publications and presentations;
  • Manages consultants and external collaborators that provide statistical and data management expertise for individual tasks or entire studies;
  • Acts as liaison between external contractor and team;
  • Ensures that statistical activities performed within the study are executed in a timely manner and to the required high statistical and other reporting standards;
  • Builds an exemplary reputation for Statistics expertise both internally and externally;
  • Establishes, promotes and maintains effective working relationships with other stakeholders, departments and functions as required;
  • Provides advice and support to Statistical Programmers, Junior Statisticians and other Medical Affairs members;
  • Keeps abreast of statistical methodological developments through literature and attendance at meetings;
  • Keeps abreast of regulatory authority guidelines relating to biostatistics and with medical issues in own project areas;
  • Is responsible for acting in line with legal, regulatory and company standards and codes of practice;
  • Completes all required training modules as a priority;

Qualifications and Experience:

  • PhD or at least MSc (Diploma) in statistics or mathematics;
  • At least 5 years experience working as a Statistician in the pharmaceutical industry or in CRO’s;
  • Relevant technical experience in statistics and statistical programming;
  • Good knowledge of international regulatory and ICH GCP guidelines;
  • Possess excellent planning and organizational skills;
  • Highly flexible with a systematic and goal-oriented working style;
  • Highly effective team work and interpersonal skills (globally, internal and externally);
  • Highly effective verbal and written communication/ presentation skills;
  • Good knowledge of the drug development process, GCP and regulatory guidelines, statistical methods for Health Outcome studies, and  the CRO business with a special focus on statistics and data management services provided;
  • Good knowledge of SAS and R;
  • Successful statistical project management and leadership skills acquired within the pharmaceutical industry or in CRO’s;
  • Broad knowledge of statistical analysis techniques and statistical processes for analysis and reporting of clinical trials;
  • Implementation and improvement of processes related to Statistics, Statistical Programming and Data Managements in Medical Affairs;
  • Fluency in written and spoken English;
  • Relevant working/residency permit or Swiss/EU-Citizenship required;

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