Director Biostatistics, Therapeutic Area Lead

Salary depends on experience
Posted on 02/18/18
King Of Prussia, PA
8 - 10 years experience
Medical Devices & Diagnostics
Salary depends on experience
Posted on 02/18/18

Job Description

RESPONSIBILITIES AND ACCOUNTABILITIES

  • Lead full scope of Biostatistics contributions to the responsible areas.  Coordinate with internal and external stakeholders through the Stage Gate process.
  • Partner with TA Head and other functional leads within the areas.  Influence and contribute to clinical development plans (CDPs/TPPs).  Ensure full integration of statistical strategy and quantitative evaluation to clinical trials, regulatory submissions, and related documents.
  • Ensure sound statistical foundation underpinning program strategy within the responsible area.  Be accountable for the quality of statistical strategy and analysis planning for clinical trials and regulatory submissions. 
  • Represent Biostatistics in interactions with authorities, including FDA, EMA, PMDA, etc.
  • Provide statistical leadership dealing with concepts and complexity comfortably.  Interact effectively with senior management and external KOL.
  • Coordinate priorities and monitor outsourcing operations within the responsible areas.  Ensure timeliness and quality of deliverables by CRO.
  • Manage the Biostatistics team to achieve corporate and department goals.  Provide technical statistical expertise, leadership and serve as a role model and mentor to staff.  Mentor staff and cultivate professional growth. 
  • Extend influence and leadership across functions.  Identify and lead opportunities for infrastructure / process / scientific consulting improvement initiatives and related standards

REPORTING RELATIONSHIP

Reports To: Head of Global Biostatistics and Statistical Programming

Direct Reports: Statisticians and/or statistical programmers

JOB SPECIFICATIONS

Education

PhD or MS in Biostatistics, Statistics, or related fields

Experience

  • 10 years of experience in Clinical Development in a Pharmaceutical or Biotechnology setting
  • Demonstrated statistical expertise and leadership in facilitating and optimizing the (pre/early/full-) clinical development strategy
  • Significant experience in interactions with major regulatory authorities and regulatory submissions
  • Experience managing people preferred
  • Experience managing CRO preferred
  • Track record of innovation desired

Competencies

  • Broad knowledge of statistical theories and applications of advanced statistical methodologies
  • Broad knowledge of clinical development and processes
  • Strong interpersonal and communication skills (verbal and written in English), comfortable around senior management
  • Ability to collaboratively work and provide leadership in matrix environment
  • Strong problem solving skills
  • Expertise in
    • Statistical methodologies
    • CDISC, statistical programming, and/or data standards
    • Biostatistics and Statistical Programming Operations

Travel Requirements

  • As needed
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