KLIFO is looking for a talented and committed Biometrician/Biostatistician
KLIFO A/S is expanding and just established its first subsidiary outside Denmark in Munich, Germany. KLIFO GmbH now wants to appoint a Biometrician/Biostatistician for the planning, analysis and reporting of clinical trials into a dynamic and experienced team within Clinical Operations Solutions in either its office in Munich or near Copenhagen (Denmark). The people we want to engage have a positive, proactive, flexible, self-driven and selfconfident personality. We can offer a highly flexible, free and trustful working climate with exciting customers and projects among competent colleagues where your knowledge, experience and contribution are valuable and highly appreciated.
KLIFO is a service provider of drug development competences and operational services to the pharmaceutical, biotech and med-tech companies in Europe, US and Asia. The areas covered by KLIFO include Clinical Trial Supply Solutions, Clinical Operations Solutions, Pharmacovigilance Solutions, Regulatory Affairs Solutions, CMC Development Solutions and Drug Development Counselling.
The position as Biometrician/Biostatistician within Clinical Operations Solutions:
Responsibilities of the Biometrician/Biostatistician include:
- Act as the primary contact person for our customers concerning trial-related statistical aspects
- Provide statistical consultancy on general or trial-related aspects, internally and externally
- Cooperate closely with data managers, SAS® programmers and project managers
- Coordinate small teams of SAS® programmers, perform quality control of SAS® programs
- 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
- Writing or peer review of statistical analysis plans
- Perform statistical analyses using SAS®
- Provide statistical contributions to clinical trial reports
- Provide statistical support for publications
- Support maintenance and further development of internal standards and of Standard Operating Procedures.
The qualifications of the Biometrician/Biostatistician:
The Biometrician/Biostatistician should possess the following qualifications and skills:
- Diploma or master in (bio-)statistics, mathematics or comparable degree
- 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 SAS® and Microsoft® Office
- Familiarity with CDISC standards
- Quality orientation, efficiency, and reliability
- Customer orientation and flexibility
- Willingness to travel occasionally
- Excellent verbal and written communication skills
- Fluent in English (spoken and written), and in either German or Danish. In addition to the above-mentioned qualifications the ideal candidate is a dedicated and collaborative team player.
- 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 a European-based company with global reach
- Work in an interactive, flexible and positive working environment
As KLIFO is a smaller service provider, you will experience a high level of transparency, influence and a good possibility for individual planning. KLIFO Denmark is located in Glostrup and KLIFO GmbH (formerly medicomp GmbH) is located in 80339 Munich, Heimeranstr. 35, Germany. Further information about KLIFO can be found at www.klifo.com.
Applications including salary expectations should be sent to: firstname.lastname@example.org, marked “Biometrician/Biostatistician”