Associate Director - Statistical Programming (Hybrid)
AbbVie
6 months ago
Remote friendly (South San Francisco, 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 and is accountable for delivering statistical programming support across therapeutic areas. Makes key recommendations and decisions related to processes, standards, and resource management.
Responsibilities:
- SAS Programming: Apply SAS programming concepts/techniques 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 standards for derived data sets and submission programs.
- Cross-Functional Collaboration: Manage priorities/resources across therapeutic areas; anticipate risks; develop contingency/escalation plans.
- 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; provide performance management for 4–10 statistical programmers.
Qualifications:
Minimum:
- Degree in Statistics, Computer Science, or related field.
- 10+ years statistical programming (with MS) OR 12+ years (with BS).
- Strong SAS programming and macro development.
- Pharmaceutical clinical trials experience.
- Regulatory filings experience (NDA/BLA/other), including ISS and ISE.
Preferred:
- Experience interacting with regulatory agencies (FDA, 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).
- Eligible for long-term incentive programs.
Responsibilities:
- SAS Programming: Apply SAS programming concepts/techniques 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 standards for derived data sets and submission programs.
- Cross-Functional Collaboration: Manage priorities/resources across therapeutic areas; anticipate risks; develop contingency/escalation plans.
- 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; provide performance management for 4–10 statistical programmers.
Qualifications:
Minimum:
- Degree in Statistics, Computer Science, or related field.
- 10+ years statistical programming (with MS) OR 12+ years (with BS).
- Strong SAS programming and macro development.
- Pharmaceutical clinical trials experience.
- Regulatory filings experience (NDA/BLA/other), including ISS and ISE.
Preferred:
- Experience interacting with regulatory agencies (FDA, 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).
- Eligible for long-term incentive programs.