Director / Senior Director, Statistical Programming
Position Overview:
- Job Titling: Associate Director, Director, or Senior Director (Titling will be determined based on years of experience and previous leadership experience).
- Prepare and/or review CDISC (SDTM and AdAM) data specifications to ensure regulatory acceptability.
- Create programming specifications by interpreting Statistical Analysis Plans, ensuring they can be utilized by both internal teams and external CRO partners to develop validated programming in support of R&D objectives.
- Collaborate with cross-functional teams to interpret the clinical trial data, develop efficient procedures for clinical data review, and other data-quality initiatives.
Qualifications:
- A minimum of 8 years of relevant experience in the pharmaceutical or biotechnology industry
- Education: Master's degree in Statistics or Biostatistics (Preferred)
- Demonstrated experience in leading a clinical asset through all phases of development
- Proven expertise in regulatory submissions, including leading and managing submission processes
- Must have leadership (People/Asset/Submission) experience; participation-only experience is not suitable for this role
Location:
- Report onsite 3 days a week in the Greater Philadelphia area.
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