Associate Director - Statistical Programming (Hybrid)
AbbVie
6 months ago
Remote friendly (Florham Park, NJ)
United States
Clinical Research and Development
The Associate Director provides statistical programming support for multiple clinical projects across multiple therapeutic areas, through individual contribution and through the work of staff. Provides training and performance management for staff. 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: Resolve non-routine problems using pharmaceutical industry SAS programming concepts and techniques.
- Standards: Oversee development/implementation of global 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/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/presentations.
- Training and Mentoring: Guide/train/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/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/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 (explicitly mentioned): Paid time off; medical/dental/vision insurance; 401(k) (eligible employees); eligible for long-term incentive programs.
Responsibilities:
- SAS Programming: Resolve non-routine problems using pharmaceutical industry SAS programming concepts and techniques.
- Standards: Oversee development/implementation of global 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/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/presentations.
- Training and Mentoring: Guide/train/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/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/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 (explicitly mentioned): Paid time off; medical/dental/vision insurance; 401(k) (eligible employees); eligible for long-term incentive programs.