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Associate Director, Statistical Programming

Company: Ascendis Pharma
Location: Palo Alto
Posted on: January 25, 2023

Job Description:

The Associate Director, Statistical Programming, will manage internal and external resources to lead or support assigned project statistical programming activities. Provide programming supports to statisticians in production of summary tables, data listings and graphs required for clinical trials, and CDISC datasets for regulatory submission. This position requires a comprehensive knowledge of SAS and CDISC standards, project and resource management, regulatory filing experience, and a broad understanding of the pharmaceutical drug development process. The Associate Director may provide statistical programming expertise on departmental and cross-functional process improvement initiatives. Other responsibilities include but not limit to: managing projects with partner and functional service providers (FSP). The position will be based in Palo Alto and will report directly to the Sr. Director, Statistical Programming. Key Responsibilities

  • Represent the Statistical Programming team as study lead, focusing on data integrity, collaboration and on-time deliverables.
  • Manage and provide oversight of Statistical Programming FTEs, contractors, and CROs.
  • Process clinical data required for statistical analysis. Develop SAS code and table templates for preparing, processing and analyzing clinical data.
  • Interact with members of project teams, statistician and data management personnel to establish project timelines and perform statistical analyses.
  • Provide support in production of summary tables, data listings and graphs required for trial report and clinical development, and CDISC data sets for regulatory submission.
  • Manage assigned project programming activities to ensure timely delivery of tables and data listings. Provide guidance and QC/QA standards to ensure quality of deliverables.
    • A bachelor's degree required in statistics, mathematics or equivalent with at least 12 years experience in pharmaceutical or bio-pharmaceutical industry or a master's degree with at least 10 years in statistics or computer science is preferred.
    • At least 3 years of experience in managing FTEs, FSPs, and CRO.
    • A minimum of 2 years experience working with CRO.
    • Prior experience in participation of NDA/BLA submissions.
    • Demonstrated leadership and excellent interpersonal skills.
    • Exceptional communication skills, with an ability to discuss programming topics with individuals ranging in programming understanding.
    • Self-motivated, with initiative and the ability to take ownership of, and follow through with, specific tasks.
    • Ability to multi-task and shift priorities quickly while working under tight deadlines.
    • New hires based in the US will be required to demonstrate that they have been fully vaccinated for COVID-19 or qualify for a medical or religious exemption or accommodation to this vaccination requirement, subject to applicable law
      • Medical insurance
      • Vision insurance
      • Dental insurance
      • 401(k)
      • Paid maternity leave
      • Paid paternity leave
      • Commuter benefits
      • Disability insurance

Keywords: Ascendis Pharma, Palo Alto , Associate Director, Statistical Programming, Executive , Palo Alto, California

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