Senior Statistician/Biostatistician Pharma
To enable optimum statistical and data management support (Umbrella only) for all clinical trials performed in or under supervision of the Medical Product Development Affairs organization, through definition of appropriate processes and supervision of external statistics and statistical programming services. Ensure timely and qualitatively excellent preparation and delivery of statistical analysis results.
- 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 (Global International Medical Directors or International Medical Directors or International Scientific Directors) 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 outside collaborators that provide statistical and data management (Umbrella only) 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 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 (e.g. Code of Conduct, applicable directives, guidelines and SOPs)
- Completes all required training modules as a priority
Qualifications and Experience:
- PhD or at least MSc (Diploma) in statistics or mathematics
- Relevant technical experience in statistics and statistical programming
- At least 5 years experience working as a Statistician in the pharmaceutical industry or in CRO’s
- Successful statistical project management and leadership skills acquired within the pharmaceutical industry or in CRO’s
- Good knowledge of international regulatory and ICH GCP guidelines
- Broad knowledge of statistical analysis techniques and statistical processes for analysis and reporting of clinical trials
- Good knowledge of the drug development process, GCP and regulatory guidelines, statistical methods for Health Outcome studies
- Sound knowledge of the CRO business with a special focus on statistics and data management services provided
- Knowledge of SAS and other statistical software packages
- Optimum statistical support for all clinical trials, publications and presentations performed in or under supervision of the Medical Affairs organization
- Implementation and improvement of processes related to Statistics, Statistical Programming and Data Managements (Umbrella only) in PDMA.
- Highly flexible with a systematic and goal-oriented working style, team work and interpersonal skills (globally, internal and externally)
- Relevant working/residency permit or Swiss/EU-Citizenship required