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Senior Statistician - Germany

  • TFS
  • Full time
  • Germany
  • 04/09/2021

TFS HealthScience is currently looking for a Senior Statistician with a minimum of 3 years experience to join our TFS Family! This role can be home based anywhere in the UK, Spain, Sweden or Germany. We look forward to receiving your application!

The Senior Statistician is part of the Global Biometrics Department within Clinical Development and will work operationally on preparing, conducting and completing Statistical tasks in assigned Study Teams, according to company policies, SOP’s and regulatory requirements.

The Senior Statistician should take the full statistical responsibility for all essential job functions and support other Statisticians in their role.

Key Responsibilities:

  • Responsible for the planning, performance, report and documentation of statistical tasks during the study process.
  • Assist in the development of Study Protocols, CRFs and reports/manuscripts by providing statistical input
  • Contact health/regulatory authorities regarding statistical issues when needed
  • Write the statistical sections in the Study Protocol
  • Review the Study Protocol
  • Review the CRF to ensure that the design and structure of the CRF meets the specific statistical requirements defined in the study protocol
  • Perform/review sample size calculations
  • Define randomization procedures and producing randomizations lists
  • Define appropriate methods for statistical analysis
  • Write/review the Statistical Analysis Plan
  • Design/review the Data Presentation Plan
  • Plan and perform statistical analysis (interim and/or final) in accordance with the Study Protocol and the statistical analysis plan
  • Support the programmers work and/or perform programming of statistical analyses and study output
  • Coordinate ADaM mapping with the senior programmer when needed
  • Validation of the defined statistical methods.
  • Document and validate programs and files for analysis
  • Manage clinical data to ensure security and confidentiality
  • Produce/review statistical reports
  • Write/review the statistical sections in the Study Report
  • Review the Study Report
  • Contact with clients in questions regarding statistical issues in projects
  • Represent TFS Biometrics in sponsor and investigator meetings
  • Responsible to escalate any issues on projects or the need for potential SOP deviations
  • Actively contribute to the organization and development of routines to enhance the work at TFS
  • Coach, support and mentor of (new) employees
  • May provide input into proposals which include Statistics and attend Bid Defense meetings face-to-face or via webex
  • File/archive essential documents
  • Requirements

  • A Master's Degree in Biostatistics, Statistics or equivalent
  • Minimum 3 years relevant statistical experience in pharmaceutical or CRO industry
  • Experience with the use of statistical methology applied to clinical trials
  • Proficiency in SAS programming
  • Excellent verbal and communication skills in English
  • Ability to deal effectively with sponsors and internal customers
  • Ability and willingness to travel on occasion
  • PLEASE SUBMIT YOUR CV IN ENGLISH

    Benefits

    What can we offer you?

    A great place to work where you will get the chance to push your career to the next level, global environment with global opportunities. You will also get the opportunity to be part of a team with highly intelligent, passionate experts from all over the world. TFS is a place for inspiration where we focus on the patients, saving lives and aiming to increase their quality of life by supporting our clients.

    Germany benefits include:

    • Entrusted work time
    • Corporate Pension Plan
    • Global General Liability Insurance
    • Global Travel Insurance

    About TFS

    We believe that a company with ethical and transparent values has a better chance of attracting skilled employees and building long-term relationships.

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