For our Swiss customer located in Basel we are currently looking for (m/f) a Senior Statistician/Biostatistician PHARMA.
• Type of placement: 11 months, external contract with possible long term extension
• Company: major Pharma company in Basel area
• Salary: level , please ask us for the exact rate range
(monthly gross salary levels in CHF, level1= 5-10k , level2=10-15k, level3= >15k) -PHARMA
Summary of Main Responsibilities:
- Develops and maintains timely, scientifically sound, innovative and business-oriented plan for the statistical analysis and data management of clinical studies (data management for Umbrella only).
- 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 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
- 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.
Context and responsibilities
- Responsible to Medical Affairs for statistical support for all clinical trials, publications and presentations performed in or under supervision or sponsorships of the Medical Affairs organization
Objectives and Scope of Position:
- To enable optimum statistical and data management support (Umbrella only) for all clinical trials performed in or under supervision of the Medica Product Development l 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
Professional and Technical Requirements:
- PhD or at least MSc (Diploma) in statistics or mathematics.
- Relevant technical experience in statistics and statistical programming
- Good knowledge of international regulatory and ICH GCP guidelines
- Shows high level of initiative, can-do attitude and customer approach
- 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
Experience, Skills, Knowledge
- Good knowledge of the drug development process
- Good knowledge of GCP and regulatory guidelines
- Good knowledge of statistical methods for Health Outcome studies
- Good knowledge of the CRO business with a special focus on statistics and data management services provided
- Good knowledge of SAS and other statistical software packages
- Fluency in written and spoken English
- 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
- Broad knowledge of statistical analysis techniques and statistical processes for analysis and reporting of clinical trials
The candidate should have
- experience interacting directly with medics (medical directors / medical science directors) to understand or influence accurate interpretation of results / evidence?
- experience designing phase III (b) or IV clinical trials?
- experience actually writing medical publications (ie., did they write or substantially influence the writing of the statistical section of a manuscript / poster)?