Senior Biostatistician - Frankfurt

Company
AL2S3 LTD
Location
Frankfurt am Main, Hessen
Salary
Up to €95,000 (D.O.E)
Posted
12 May 2021
Closes
11 Jun 2021
Ref
JZFFSRBS
Hours
Full Time
Contract Type
Permanent
Experience Level
Experienced (non-manager)

Senior Biostatistician – Frankfurt, DE

Office-based/ Homebased

Up to €95,000 (Salary D.O.E)

Experience: 3+ Years Required

Josh Zarembski is pleased to offer a fantastic opportunity to an experienced Biostatistician, with a leading Pharmaceutical organisation focused in the global market areas of Aesthetics &Therapeutics.

The innovative spirit of this company and the commitment to their staff make them an ideal organisation to take the next steps in your career. They have a highly attractive portfolio, a strong strategic focus, and a dynamic team which is leading to long-term growth and success.

This position can mainly be worked remotely with 1 day a week office based in Frankfurt to maintain social interaction of the team. Teamed with a strong compensation package, you will have the option of flexible working hours, personal & professional development plans.

Responsibilities

  • 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

Requirements

  • Graduate studies in Statistics, Mathematics, Natural Sciences or similar
  • At least 3 years experience in Biostatistics
  • Business fluent in English (written and spoken)
  • 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 awarenessess
  • Analytical and highly structured way of working

Apply

  • AL Solutions are a niche Life Science recruitment consultancy. We place professionals across the UK/EU for a variety of biotechnology, pharmaceutical and CRO companies ranging from small start-ups to large global organisations.
  • If you’re interested, please apply below. If this position doesn’t interest you, please visit our website for a list of more vacancies – www.alsolutions.co.uk or reach out to us via:

Josh Zarembski

AL Solutions