Director Biostatistics

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POST DATE 8/10/2016
END DATE 11/9/2016

PAREXEL Durham, NC

Company
PAREXEL
Job Classification
Full Time
Company Ref #
pare-10054063
AJE Ref #
575837630
Location
Durham, NC
Experience
Mid-Career (2 - 15 years)
Job Type
Regular
Education
Doctoral Degree

JOB DESCRIPTION

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The Director Biostatistics contributes to and leads strategic initiatives for the structure and development of the Biostatistics department in order to achieve the overall goals and mission of PAREXEL. The Director is responsible for managing a team of Statisticians or Managers who themselves manage teams of statisticians involved in the production of clinical trial reports and in the provision of statistical services. This position requires experience in regulatory submissions.Key Accountabilities Identify strategic needs within the Biostatistics department Develop and successfully implement a plan for strategic initiatives Represent the Biostatistics department in high-level internal PAREXEL initiatives Represent PAREXEL at client marketing and technical meetings Business development and the identification of new business opportunities Maintain and monitor budgets for non-billable spending Manage the recruitment process for new Biostatistics team members Resources Planning Evaluate and resolve complex personnel issues Implement disciplinary procedures if required Coordinate development of client proposal documents Resolve client problems when and as they arise Consult with clients on technical, statistical or regulatory issues, as appropriate Provide support to Functional Lead in terms of changes in scope and contractual issues Provide internal technical support to the Biostatistics department Develop agendas and chair departmental meetings Lead the development of new SOPs and guidelines as needed Identify the need for process and quality improvement initiativesQualifications Financial knowledge, able to read a Profit and Loss (P&L) summary and present financial information Strategic awareness of our business environment Detailed awareness of the activities of other groups within PAREXEL Advanced people management and leadership skills Able to work with senior managers on strategic initiatives Highly professional attitude Attention to detail Excellent analytical skills Able to work under pressure and motivate others Thorough understanding of statistical issues in clinical trials Excellent knowledge of all statistical and reporting processes within the Biostatistics department. Thorough understanding of e-submissions, eCTD, 21CFR parts 11, 54, 56, 312, and 314 Thorough understanding of ICH guidelines Thorough understanding of regulatory guidance pertaining to specific indications and also to electronic submissions Thorough understanding of issues related to adaptive trials 10+ years relevant work in industry or CRO setting & PhD or 12+ years relevant work at MS-level educationEEO DisclaimerPAREXEL complies with all applicable federal, state, and local laws prohibiting discrimination in employment. All qualified applicants will receive consideration for employment without regard to gender, age, race, color, religious creed, marital status, sexual orientation, national origin, ethnicity, ancestry, citizenship, genetic information, disability, protected veteran status or any other characteristic protected by applicable federal, state or local law.
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