Senior Statistical Programmer

6 days ago


Plano, Texas, United States Orano Med, LLC. Full time
Job Summary

The Senior Statistical Programmer will be responsible for providing statistical programming support for clinical trials and programs, including submissions to Health Authorities. This role will also support in-house ad hoc programming requests.

Key Responsibilities
  • Collaborate with biostatisticians, data managers, and clinical study teams to ensure accurate and timely delivery of data and analysis results.
  • Serve as the primary point of contact for statistical programming and coordinate outsourced programming activities.
  • Oversee outsourced statistical analysis and reporting deliverables to ensure compliance with industry standards and regulatory guidelines.
  • Ensure data packages for health authority submissions comply with applicable submission requirements.
  • Maintain statistical datasets that support clinical development and safety.
  • Provide statistical programming support for ad-hoc requests.
Requirements
  • Bachelor's or Master's degree in Statistics, Computer Science, Mathematics, Life Sciences, or a related field.
  • Minimum of 5-7 years of experience in statistical programming in the pharmaceutical or biotechnology industry.
  • Proven experience in supporting NDA submissions to the FDA.
  • Experience with regulatory agency interactions and audits is preferred.
Preferred Qualifications
  • Extensive experience with SAS and clinical trial programming.
  • Strong understanding of dataset submission requirements.
  • In-depth knowledge of CDISC standards.
  • Ability to comprehend analysis plans and statistical terminology.
Benefits
  • Competitive compensation.
  • Health, Dental, and Vision insurance.
  • 401(k) with employer matching and contribution amounts.
  • Life insurance and Short- and Long-Term Disability insurance.
  • Generous Paid Time Off and holiday schedules.
  • Numerous Training and Development opportunities.


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