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Biostatistician

  • TFS
  • Full time
  • United States
  • 10/02/2021

TFS is a Global CRO headquartered in Sweden. We genuinely believe that “Global in mind and local at heart” is the core of our success; we operate in a global environment while retaining an in-depth knowledge of regulatory requirements in every country where we operate. At TFS, you will be offered the possibility to develop in a global organization with a company culture distinguished by passion, innovation and talent.


The Senior Biostatistician 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, SOPs and regulatory requirements.

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


Key responsibilities:

  • Responsible for 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
  • Contract 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 the 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 analysis and study output
  • Coordinate ADam mapping with Sr. 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
  • Represent TFS Biometrics in sponsor and investigator meetings
  • Coach support and mentor new employees
  • Attend bid defense meetings face-to face or via webex
  • Requirements

    • A Bachelor of Science or Master's Degree in Statistics, Biostatistics or equivalent
    • Minimum of 5 years relevant statistical experience in pharmaceutical or CRO industry
    • Proficiency in SAS programming
    • Excellent verbal and communication skills
    • Ability to deal effectively with sponsors and internal customers
    • Ability and willingness to travel on occasion

    Benefits

    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

    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.