Principal Biostatistician (Remote)

Company: Ascent Services Group
Location: Philadelphia
Posted on: February 25, 2021

Job Description:

Job Location:Philadelphia, PA(Remote) or Any US Remote Location Job Overview: Provides all biostatistical services to meet the requirements of all clients, including full-service, Bioinformatics, and other type studies. Meets all the job duties, responsibilities, and requirements of a Senior Biostatistician in addition to those listed here. 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. 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 sponsor.
• Overall high quality work and a strong reputation for statistical knowledge.
• In general, Principal Biostatisticians would be expected to contribute more in billable areas. Supervisory Responsibilities:May be given some supervisory responsibilities for staff or departmental areas. 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.
      • 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 younger 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 completed GCP training and has strong knowledge of 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 Bioinformatics 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 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. Job Type: Direct Placement
          Location: Morrisville, NC
          Job ID: 20-08568
          Date Updated: January 5, 2021 Alicia Licht is recruiting for this position. Corporate Office
          1001 Galaxy Way, Suite 405
          Concord, CA 94520
          925-627-4900
          info@ascentsg.com Employment Verifications
          Via The Work Number, employer code 105779 Additional office locations in Chico, CA; Chicago, IL; Los Angeles, CA.

Keywords: Ascent Services Group, Philadelphia , Principal Biostatistician (Remote), Other , Philadelphia, Pennsylvania