Associate Director - Statistical Programming (Hybrid)

The Associate Director provides statistical programming support for multiple clinical projects across multiple therapeutic areas, both through individual contribution and through the work of staff. Provides training and performance management for staff. Demonstrates leadership competencies, builds relationships, and promotes teamwork within Statistical Programming and across functions. Accountable for ensuring statistical programming support is delivered across multiple therapeutic areas. Makes key recommendations and decisions related to processes, standards, and resource management. Responsible for staff management and development.

Responsibilities:
- SAS Programming: Strong understanding of SAS programming concepts and techniques used in the pharmaceutical industry; resolve non-routine problems.
- Standards: Oversee global standards for output design and programming conventions; monitor regulatory guidance and industry best practices.
- CRFs and Database Definitions: Provide strategic guidance on CRF and database design; review global standards.
- Derivation Programming, Submission Data Sets, and Programs: Interpret statistical analysis plans; develop analysis data set specifications; oversee global standards for derived data sets and submission programs.
- Cross-Functional Collaboration: Manage priorities and resources across therapeutic areas; anticipate risks; develop contingency/escalation plans.
- Communication: Present concepts, risk assessments, and recommendations clearly to scientific and non-scientific audiences; lead meetings and presentations.
- Training and Mentoring: Guide, train, and mentor staff to support development and ensure compliance with training requirements.
- Staff Management: Assign responsibilities, define scope, review progress; allocate resources; set expectations and promote open communication; provide performance management for 4–10 statistical programmers.

Qualifications
Minimum Qualifications:
- Degree in Statistics, Computer Science, or a related field.
- 10+ years statistical programming experience (with MS) OR 12+ years (with BS).
- Strong technical competence in SAS programming and macro development.
- Experience in pharmaceutical clinical trials.
- Experience with regulatory filings (NDA, BLA, or other submissions), including ISS and ISE.

Preferred Qualifications:
- Experience interacting with regulatory agencies (especially FDA and EMEA).
- Previous management experience.

Other Required Skills:
- Working knowledge of ICH guidelines and relevant regulatory requirements.
- Strong oral and written communication skills.

Benefits:
- Paid time off (vacation, holidays, sick), medical/dental/vision insurance, and 401(k) to eligible employees.
- Eligible to participate in long-term incentive programs.