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Associate Director, Biostatistics

Date: Jun 1, 2019

Location: Stamford, CT, US, 06901

Company: Purdue Pharma L.P. & Affiliates

Working at Purdue

Purdue Pharma is a privately held pharmaceutical company.  Purdue develops and provides prescription medicines that meet the evolving needs of healthcare professionals, patients, and caregivers.  The Company was founded by physicians and is currently led by physicians.  Beyond efforts to provide quality medications, Purdue is committed to supporting national, regional, and local collaborations to drive innovations in patient care.  In addition, Purdue is pursuing a pipeline of new medications and technologies through internal research and development and strategic industry partnerships.

Job Summary

The Associate Director, Biostatistics will provide leadership and guidance as the lead statistician on a project team and additionally be accountable for all statistical aspects of clinical studies and projects, including quality, relevance to regulatory perspective, and scientific validity.  Act as key statistical function representative within the company. 

Primary Responsibilities

  • Provide statistical support to multiple project teams.  Collaborate with clinical and regulatory leads in defining general strategic approach, creating clinical development plans (CDP), and individual protocols. Work independently, or with alternative resources (i.e., consultants, CROs) to satisfy needs of assigned projects, develop effective statistical approaches applicable to project. 
  • Provide statistical expertise to support Due Diligence projects. Collaborate with clinical and other function leads (e.g., commercial, regulatory) to evaluate new potential drug candidates and identify potential gaps/risks.
  • Oversee design and execution of statistical methods (SAP), statistical analyses, and results (e.g., summary sections for clinical study reports (CSR)).  Review and approve key results and statistical conclusions.  Provide guidance to the clinical and regulatory teams regarding conclusions and inferences from the data package.  Statistical deliverables consistently compliant, in timing and quality, with SOPs and departmental standards.
  • Interact with relevant stakeholders to ensure that appropriate statistical methods are adequately and consistently applied in all scientific and regulatory documents, presentations, and publications. Provide scientific/statistical insight in addressing questions from clients, and propose novel solutions to technical issues.
  • Independently pursue analyses suggested by the data, including the pursuit of statistical knowledge needed to address the scientific issue. In collaboration with Statistical Programming, ensure that all internal and external statistical software used in the performance of analyses defined in SAPs or scientific research plans are efficient, validated, and meet internal SOPs and external regulatory requirements.
  • Provide general guidance on definition and documentation of key derived variables needed to support production of tables, listings, and figures (TLF).  Ensure consistency of data collection and analysis across studies within a project. Ensure analysis datasets are quality controlled, sufficient to produce TLF for reports.  General compliance with Industry data standards, e.g. CIDSC and company standards.
  • Plan and track project activities, timelines across projects.  Provide justification to the outsourcing teams for planned resource needs.  Seek to optimize resource utilization and capacity.  Effectively plan and manage statistical resources to meet assigned project priorities.
  • Maintain awareness of industry standards, regulatory requirements, and departmental guidelines and SOP. Within area of control, update procedures or practices as needed to remain in compliance.  Procedures and practices meet industry standards and are consistent with internal SOP.  

Education and Experience

  • PH.D. or Master’s degree in Bio-Statistics or closely related discipline from accredited college or university.
  • Minimum 5 years of hands on Bio-statistics experience in the Pharmaceutical or Biotech industry
  • Minimum 3 years’ experience managing and overseeing external agencies, such as CRO or consultant groups
  • Minimum of 3 years of SAS programming experience. 

Necessary Knowledge, Skills, and Abilities

  • Demonstrated leadership, project management, and interpersonal skills
  • Excellent written and verbal communication skills
  • Excellent presentation skills to groups of varied size and make up.
  • Demonstrated broad knowledge and superior understanding of advanced statistical concepts and techniques
  • Proven ability to innovatively apply technical principles, theories, and concepts to pharmaceutical clinical development and life cycle management
  • Proven ability to effectively represent Biostatistics and Programming in multidisciplinary or cross-functional meetings
  • Proven ability to work in a fully self-directed manner
  • Proven ability to independently write SAS programs in adherence to clinical and statistical objectives

Supervisory Responsibilities (if Applicable)

Additional Information

An Equal Opportunity Employer M/F/D/V

Req Id19642

Nearest Major Market: Bridgeport
Nearest Secondary Market: Danbury

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