Our Client, a NASDAQ-traded Drug Discovery company, develops antibody-based therapeutics for the treatment of cancer, autoimmune- and inflammatory diseases. The company employs more than 120 professionals in its Munich and Bethesda locations where it combines excellent science with a highly, integrated development organization. It complements in-house competence with a network of academic and industrial partners. The Client is currently seeking for its Munich location a

Statistician / Clinical Data Manager

as Senior Director / Vice President

to manage and analyze clinical data and provide statistical support for clinical development programs. This position reports directly to the Chief Medical Officer and requires excellent verbal fluency and advanced written proficiency in English. Knowledge of German is helpful but not essential.

Key Responsibilities

• Statistical support of clinical development programs
• Management and analysis of clinical and research data including close interaction with external providers of statistical and data management services
• Preparation of data packages for internal and external review meetings including regulatory filings
• Statistical support for writing meeting abstracts, publications, and development of presentations for internal and external use
• Statistical support for writing of clinical protocols and other clinical development/regulatory documents
• Close interaction across the whole clinical development team, clinical operations team and external data management to support initiation and completion of clinical trials and subsequent clinical study reports and regulatory filings
• Close interaction with Research, Preclinical Development, Regulatory Affairs and other Departments to assure timely and proper Drug Development

Profile

The ideal Candidate for this position will be an expert in statistics and data management, with at least 5 years experience:

• managing contacts with external database holders (with ongoing clinical trials)
• working on medical reviews of important/pivotal clinical trials
• supporting investigator meetings, DMCs/DRCs/IDMCs and advisory board meetings
• supporting filing(s) of NDA(s) and/or MAA(s)
• working within a global setting (e.g., globally active pharmaceutical company) in the context of hematology and/or oncology

In addition to the above experience, the Candidate should have statistical qualifications (Master’s degree or equivalent) or a scientific background (PhD, or comparable), with at least 5 years of experience in data management and statistical assessments in the pharmaceutical/biotech industry. Integrity with regard to data assessment is essential, combined with willingness to travel and strong personal and presentation skills.

If you have the above qualifications and are interested in working for a dynamic company in one of the most popular and beautiful areas in Germany, please let us know!

hier bewerben! please apply here