Associate Director - Statistical Programming (Hybrid)
AbbVie
6 months ago
Remote friendly (Irvine, CA)
United States
Clinical Research and Development
The Associate Director provides statistical programming support for multiple clinical projects across multiple therapeutic areas, including through individual contribution and staff work. Provides training and performance management for staff, demonstrates leadership competencies, builds relationships, promotes teamwork across functions, ensures delivery of statistical programming support across therapeutic areas, makes key recommendations and decisions on processes/standards/resource management, and is responsible for staff management and development.
Responsibilities:
- SAS Programming: Apply SAS programming concepts/techniques used in pharma to 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 datasets and submission programs.
- Cross-Functional Collaboration: Manage priorities/resources across therapeutic areas; anticipate risks; develop contingency/escalation plans; contribute to cross-functional initiatives.
- Communication: Present concepts, risk assessments, and recommendations clearly; lead meetings and presentations.
- Training and Mentoring: Guide, train, and mentor staff; ensure compliance with training requirements.
- Staff Management: Assign responsibilities, define scope, review progress; allocate resources; collaborate on staffing needs; set expectations and drive organizational goals; provide performance management for 4–10 statistical programmers.
Qualifications:
Minimum
- Degree in Statistics, Computer Science, or related field
- 10+ years statistical programming experience (with MS) OR 12+ years (with BS)
- Strong SAS programming and macro development competence
- Experience in pharmaceutical clinical trials
- Experience with regulatory filings (e.g., NDA/BLA or other submissions), including ISS and ISE
Preferred
- Experience interacting with regulatory agencies (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; 401(k) to eligible employees
- Eligible for long-term incentive programs
Responsibilities:
- SAS Programming: Apply SAS programming concepts/techniques used in pharma to 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 datasets and submission programs.
- Cross-Functional Collaboration: Manage priorities/resources across therapeutic areas; anticipate risks; develop contingency/escalation plans; contribute to cross-functional initiatives.
- Communication: Present concepts, risk assessments, and recommendations clearly; lead meetings and presentations.
- Training and Mentoring: Guide, train, and mentor staff; ensure compliance with training requirements.
- Staff Management: Assign responsibilities, define scope, review progress; allocate resources; collaborate on staffing needs; set expectations and drive organizational goals; provide performance management for 4–10 statistical programmers.
Qualifications:
Minimum
- Degree in Statistics, Computer Science, or related field
- 10+ years statistical programming experience (with MS) OR 12+ years (with BS)
- Strong SAS programming and macro development competence
- Experience in pharmaceutical clinical trials
- Experience with regulatory filings (e.g., NDA/BLA or other submissions), including ISS and ISE
Preferred
- Experience interacting with regulatory agencies (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; 401(k) to eligible employees
- Eligible for long-term incentive programs