Sr Manager Statistical Programming

Teva Pharmaceutical Industries-posted 2 months ago
Full-time • Senior
West Chester, PA
5,001-10,000 employees
Chemical Manufacturing
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The Senior Manager, Statistical Programming, provides comprehensive programming leadership for programming deliverables within a product/program. This role is responsible for managing the timely and accurate execution of programming components of clinical trials and supports the development, regulatory approval and market acceptance of Teva Products. The Senior Manager leads and manages projects that involve global tasks, cross functional teams, or outsourcing resources. The role requires providing inputs to design and analysis, and reporting the results of clinical trials, including programming rules and mocked T/L/G. In addition, the Senior Manager of statistical programming supports improvement initiatives, support change management through communication, training, and stakeholder engagement, and proactively address risks with remediation strategies.

  • Primarily works at the product / program level
  • Possible to have direct reports; likely to oversee contingent workers and/or vendors; likely to provide training to others; analyzes needs to manage resources.
  • Mentor Jr Level programmers on the use of department standardization tools/processes.
  • Manages and delivers assignments with quality and within timelines and provides input for budget planning.
  • Independently develops, validates, and maintains complex programs and utilities in accordance with predefined specifications and standards.
  • Provides strong programming support to CDISC based e-submission.
  • Develop, review, and/or perform validation of generic macros.
  • Develop, debug, and enhance SAS (or any other Statistical software) programs to support quality control of safety or efficacy derived datasets.
  • Reviews key planning documents (e.g, Protocol, statistical analysis plan) to ensure alignment with project objectives.
  • Contributes to development of data presentation plan (DPP), programming specifications (e.g. SDTM, ADaM specs), regulatory reviewers guide documents.
  • Ensures clarity and completeness of programming requirements, and robustness of assumptions.
  • Implement programming standards and comply with regulatory requirements among project team members and across all projects.
  • Communicate to management on project status and resource issues.
  • Responsible for the standardization of GSD deliverables across study projects within an indication/therapeutic area.
  • Contributes to the overall definition of programming rules and standardization across therapeutic areas and/or indication.
  • Identifies, supports process and technology improvement initiatives.
  • Communicates proactively and effectively around issues and risks and contributes to remediation strategies.
  • Leads global projects with cross-functional involvement; demonstrates project management and leadership capabilities.
  • Contributes to departmental policies, standards, and best practices.
  • Education Required: Bachelor's Degree OR Master's Degree in Science, Statistics, Information Technology or equivalent combination of education and related work experience.
  • Experience Required: Bachelors + 7 years, Masters + 6 years in a pharmaceutical or clinical research setting as a programmer.
  • Functional Knowledge: Expert level of programming skills and problem resolution in SAS or other Statistical programming software.
  • Company/Industry Related Knowledge: Advanced knowledge of government regulations pertaining to drug development in multiple therapeutic areas.
  • Strong understanding of clinical data structures (e.g. CDISC).
  • Comprehensive Health Insurance: Medical, Dental, Vision, and Prescription coverage starting on the first day of employment, providing the employee enrolls.
  • Retirement Savings: 401(k) with employer match, up to 6% and an annual 3.75% Defined Contribution to the 401k plan.
  • Time Off: Paid Time Off including vacation, sick/safe time, caretaker time and holidays.
  • Life and Disability Protection: Company paid Life and Disability insurance.
  • Additional benefits include Employee Assistance Program, Employee Stock Purchase Plan, Tuition Assistance, Flexible Spending Accounts, Health Savings Account, Life Style Spending Account, Volunteer Time Off, Paid Parental Leave, Family Building Benefits, Virtual Physical Therapy, Accident, Critical Illness and Hospital Indemnity Insurances, Identity Theft Protection, Legal Plan, Voluntary Life Insurance and Long Term Disability.
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