Principal Biostatistician
Responsibilities;
- Provide statistical consultancy on general or trial related aspects, internally and externally
- Cooperate closely with study team members such as data managers, programmers and project managers
- Statistical planning of clinical trials: provide statistical input to trial designs and perform sample size calculations
- Writing or peer review of the statistical sections of clinical trial protocols
- Ensure appropriate randomisation procedures as applied
- Writing or peer review of statistical analysis plans
- Coordinate small teams of programmers, perform quality control of programs
- Perform statistical analyses using SASยฎ (or other appropriate software)
- Provide statistical contributions to clinical trial reports
- Provide statistical support for publications
- Interpretation and visualization of trial data
- Provide input to Risk Based Quality Management (RBQM) including risk assessment and risk controls
- Support maintenance and further development of internal standards and of Standard Operating Procedures
- Ad-hoc tasks within the department
- Act as the primary contact person for clients concerning statistical aspects
- Act as mentor for other biostatisticians
- Work with no or only minimal supervision
Requirements;
- Diploma or master in (bio-)statistics, mathematics or comparable degree
- At least 1-4 years professional experience with planning, analysis and reporting of clinical trials in the pharmaceutical or biotech industry, in a CRO or in an academic environment
- Knowledge of relevant regulatory guidelines
- Profound knowledge of SASยฎ
- Good knowledge of MicrosoftยฎOffice
- Good verbal and written communication skills
- Fluent in English (spoken and written)
- Proven knowledge of tasks and deliverables within biostatistics
- The ideal candidate is a dedicated and collaborative team player
Benefits;
- Work within different therapeutic areas and with tasks of varying complexity
- Work with a heterogeneous client pool (pharmaceutical companies, established biotech, inexperienced biotech, investigators/academia)
- Use - and elaborate - your competences and experience
- A team of experienced colleagues
- Work in an interactive, flexible and positive working environment