Principal Biostatistician

  • Clinipace
  • Frankfurt am Main, Germany
  • 24/11/2021
Full time Data Engineering Data Analytics Artificial Intelligence Statistics Biostatistics

Job Description

Job Title: Principal Biostatistician

Job Location: Frankfurt, Germany (Remote, Homebased position, any location in Germany considered)

Job Overview:

Provides all biostatistical services to meet the requirements of all Clinipace clients, including full-service, Global Clinical Analytics (GCA), and other type studies.

Job Duties and Responsibilities:

A Principal Biostatistician is expected to be a very successful Senior Biostatistician who establishes excellence in one or more areas providing some unique leadership to Clinipace. Examples of areas of excellence include but are not limited to:

  • Proven written and oral communications with regulatory agencies.
  • Special expertise in more complex statistical analytical methods not well known to all biostatisticians.
  • Established expertise in a medical therapeutic area.
  • Established a long-term high-level relationship with a Clinipace sponsor.
  • Overall high-quality work and a strong reputation for statistical knowledge.
  • Exhibited leadership and organizational skills to plan, supervise, implement, and monitor the statistical processes for multiple clinical trials.
  • Demonstrated ability to adapt and adjust to changing priorities and deal with uncertainty and risks.
  • May be given some supervisory responsibilities for junior staff or department areas.

Supervisory Responsibilities:

No supervisory responsibilities.

Job Requirements:

Education

  • PhD or Master’s in statistics or related area, or equivalent degree globally

Experience

  • PhD + 7-10 years (or MS + 10 years) experience in pharmaceutical, CRO, or related environment.
  • Skills/Competencies
    • Interpersonal and communication skills: Excellent written and oral communication skills including technical writing of all statistical results.
    • Ability to develop professional presentations for presenting statistical issues and solutions to clients internally.
    • Ability to effectively learn and handle new or unfamiliar statistical methods.
    • Ability to find needed written resources and interact with other Biostat staff with the needed familiarity.
    • Willingness to share expertise with junior staff members.
  • Capabilities
    • Excellent broad ranging understanding of statistical methods and issues. Demonstrates leadership in several areas of statistics.
    • Has a developed expertise in 1-2 therapeutic areas.
    • Ensures statistical quality: Reviews and monitors quality of statistical tasks and project deliverables provided by statistical project team.
    • Deep working knowledge of clinical drug development process: In-depth understanding of phases of clinical trials and relevant statistical considerations that apply to Phase I-IV studies and non-inferiority concepts.
    • Has strong knowledge of GCP and ICH guidelines and other regulatory guidelines related to statistics.
    • Develops capability for interacting with regulatory agencies on behalf of sponsor matters. Such capability would include ability to write statistical reports and/or present oral arguments to such agencies.
    • Ability to serve as a Project Manager for GCA studies. Coordinate keeping tasks and project activities in line with agreed timelines and budget.
    • Excellent training and presentation skills: Has the ability to clearly communicate statistical concepts and successfully train and develop staff through coaching and presentations.
    • Strong understanding of departmental and company procedures which relate to tasks that are performed routinely: Strong understanding of all departmental SOPs and good understanding of all required company SOPs.
    • Familiarity with Clinipace Functional Areas that Biostatistics interacts with on a regular basis (Proposals, Finance, Clinical Operations, Data Management, Medical Writing), and updates appropriate personnel regarding project scope changes which may impact their areas.
    • Support the Business Development process through RFP process, bid defenses, attendance at scientific meetings, etc.

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