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Ultragenyx Pharmaceutical logo
Ultragenyx Pharmaceutical

Ultragenyx Pharmaceutical, founded in 2010, is a biotechnology company that specializes in bringing products to market to treat rare, ultra-rare, and serious ge

Director, Statistical Programming

Location

United States

Posted

77 days ago

Salary

$206.6K - $255.2K / year

Seniority

Lead

Postgraduate Degree10 yrs expEnglish

Job Description

Director, Statistical Programming

Ultragenyx Pharmaceutical

• Manage all programming activities on one or multiple projects/studies across all therapeutic areas, both internally and externally by CROs • Provide leadership in balancing conflicting priorities, promoting communication and adequate information flow to motivate, encourage, and align people with the company's strategic objectives • Work collaboratively with Clinical Operation, Data Management, Global Drug Safety, Regulatory, Project Management, and other functions/staff to meet project deliverables and timelines for statistical data analysis and reporting • Provide technical input into documents produced by other functions (e.g. biostatisticians, data managers, medical writers) • Works with other functions for the development and maintenance of the data review and reporting tools, and any other statistical applications as appropriate • Participate in the statistical programming training as appropriate • Ensure proper implementation of company data standards and industry submission data standards • Implement standards and project management • Act as programming representative in a multidisciplinary study team to ensure timely and quality support for analysis and reporting of clinical trials up to regulatory approval, product launch, and annual reports • Ensure project milestones are met to facilitate decision-making and address business needs

Job Requirements

  • Master’s Degree in Statistics, Computer Science, Mathematics, Engineering, or related discipline preferred
  • Minimum of 10 years of clinical trial programming experience in the biotechnology, pharmaceutical, or health-related industry
  • Advanced SAS programming skills and experience in other statistical software, such as R and S-Plus
  • Experience and in-depth knowledge of CDISC including SDTM, ADaM, and controlled terminologies
  • Direct experience with eCTD submissions (FDA/EMA/PMDA) and creating Define.xml and Reviewer’s Guide.
  • Self-directed, technically strong, and a recognized leader maintaining a strategic perspective regarding statistical programming processes, management of statistical programmers, and customer management
  • Vendor management experience

Benefits

  • Generous vacation time and public holidays observed by the company
  • Volunteer days
  • Long term incentive and Employee stock purchase plans or equivalent offerings
  • Employee wellbeing benefits
  • Fitness reimbursement
  • Tuition sponsoring
  • Professional development plans

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