Director, Statistical Programming

📋 Description

• Provide leadership and programming support to Clinical Development across one or more indications.
• Collaborate with statisticians, data managers, CROs on deliverables.
• Lead programming deliverables from study start-up to regulatory submission.
• Lead design, development, and validation of CDISC submission packages.
• Review CRO deliverables for SAP adherence, CDISC standards, and submission readiness.
• Mentor junior staff and contribute to recruitment of programmers.

🎯 Requirements

• MS in Statistics/CS/Math/Engineering/Life Science; 10–12 yrs pharma programming; BS with 12+ yrs.
• Advanced SAS programming skills in a clinical data environment.
• Extensive knowledge of CDISC, ICH, GCP, and 21 CFR Part 11.
• Leverage AI and automation to enhance programming efficiency.
• Experience in AML oncology and regulatory submissions globally (preferred).
• Strong communication and cross-functional collaboration.

🎁 Benefits

• Career advancement and development opportunities.
• Competitive compensation package with equity and bonus.
• 401K with employer contributions.
• Generous stock options and ESPP plan.
• Paid time off: 20 days and holidays.
• Commuter stipend (Boston Office) and lunch perks.