Biostatistician (m/f/x) - Cologne, Deutschland - SciPro

Beschreibung

(Senior) Biostatistician (m/f/x) | fully remote from Germany | Pharma

In this position you will play a key role in conducting and overseeing biostatistical activities in development programs and clinical trials with medicinal products and medical devices. Main tasks include optimizing processes in biostatistics to support the team growth, statistical planning, data collection and validation as well as CRO oversight and cross-functional interactions with other R&D functions and Medical Affairs.

What will your tasks as "(Senior) Biostatistician (m/f/x)" be?

• You provide statistical input to clinical development programs and clinical trials / investigations, including Clinical Development Plans, CTDs, etc.
• You define statistical aspects of a clinical trial in the Clinical Trial Protocol including writing the Statistical Analysis Section
• You review and provide input to Clinical Trial Protocols, Clinical Study Reports, etc.
• You deliver input to data collection instruments (e.g. CRF, diary), data management and data validation processes (e.g. data validation checks), definiton of risk-based monitoring procedures (e.g. signal detection process) and other aspects of data collection and validation
• You specify, coordinate or conduct and quality control the statistical analysis activities for individual studies and integrated analyses (e.g. ISE, ISS).
• You define randomization process details; initiate, coordinate and conduct unblinding process
• You oversee statistical activities outsourced to CRO
• You coordinate and discuss all statistical aspects in interaction with regulatory bodies such as Scientific Advice Meetings
• You review and provide input to scientific publications and present study results
• You interact with other R&D functions and Medical Affairs including consultation on statistical topics (e.g. in preclinical projects, publications, etc.)
• You optimize and update biostatistics processes to reflect possible changes in regulatory and organizational requirements

Your requirements as "(Senior) Biostatistician (m/f/x)"?

• University degree in Statistics or Mathematics
• 3+ years' experience in Biostatistics
• Familiarity with ICH, GCP, FDA guidelines
• Experience with EDC systems and SAS, ideally experience with CDISC data standards
• Strategic and analytical thinking
• Excellent communicating and team player skills
• High sense of responsibility and quality awareness
• Analytical and highly structured way of working
• Conversational German skills (B1/B2)
• Business fluent in English (written and spoken); any other language would be a plus

Information about our client:

Our client is a leading pharmaceuticals & medical devices companies in Europe. The company is more than 100 years old and it's more than 3000 employees are operating in 50+ countries. The company is very active in research, development, and distribution of further innovative products.

Application process:

• CV to my email:
• Call with a presentation of the company
• I am your contact person for the entire application process (interviews to contract negotiations) i.e. You don't have to apply yourself
• Discuss other exclusive positions that are tailored to your profile

My contact details:

• Email:
• Tel: / direct dial)

I look forward to your application