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.