Associate Director - Statistical Programming (Hybrid)
AbbVie, Irvine, CA, United States
Associate Director - Statistical Programming (Hybrid)
Full-time
Salary Min: 141500
Salary Max: 268500
Workday Global Grade: 20
Compensation: USD 141,500 - USD 268,500 - yearly
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. The Associate Director provides training and performance management for staff. The Associate Director demonstrates leadership competencies, builds relationships, and promotes teamwork within the Statistical Programming organization and across functions. The Associate Director is accountable for ensuring statistical programming support is delivered across multiple therapeutic areas. The Associate Director makes key recommendations and decisions related to processes, standards, and resource management. The Associate Director is also responsible for staff management and development.
Responsibilities
SAS Programming:
Demonstrates a strong understanding of SAS programming concepts and techniques used in the pharmaceutical industry and applies that knowledge to resolve non-routine problems.
Standards:
Oversees the development and implementation of global company standards for output design and programming conventions and monitors regulatory guidance and industry best practices.
CRFs and Database Definitions:
Provides strategic guidance on CRF and database design and reviews global standards related to these deliverables.
Derivation Programming, Submission Data Sets, and Programs:
Interprets statistical analysis plans, develops analysis data set specifications, and oversees the development and implementation of global standards for derived data sets and submission programs.
Cross-Functional Collaboration:
Works collaboratively with stakeholders to manage priorities and resources across therapeutic areas. Demonstrates a solid understanding of drug development principles, anticipates risks, develops contingency and escalation plans, and contributes to cross-functional initiatives.
Communication:
Presents statistical programming concepts, risk assessments, and recommendations clearly and persuasively to statisticians, scientists, programmers, and non-scientists. Effectively leads meetings and presentations.
Training and Mentoring:
Provides guidance, training, and mentoring to staff to support development and ensure compliance with training requirements.
Staff Management : Assigns responsibilities, defines scope, and reviews progress to ensure projects are delivered on time and with appropriate quality. Allocates resources to maintain the right balance of expertise across projects and collaborates with management to assess staffing needs. Sets high expectations, promotes open communication, and leads staff to meet organizational goals. Provides performance management for 4–10 statistical programmers.
Minimum Qualifications
Degree in Statistics, Computer Science, or a related field
10+ years of statistical programming experience (with MS) OR 12+ years of statistical programming experience (with BS)
Strong technical competence in SAS programming and macro development.
Experience in pharmaceutical clinical trials.
Experience with regulatory filings such as NDA, BLA, or other submissions, including ISS and ISE experience.
Preferred Qualifications
Experience interacting with regulatory agencies, especially FDA and EMEA.
Other Required Skills
Working knowledge of ICH guidelines and relevant regulatory requirements.
Strong oral and written communication skills.
We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.
This job is eligible to participate in our long-term incentive programs.
AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled.
US & Puerto Rico applicants seeking a reasonable accommodation.
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Full-time
Salary Min: 141500
Salary Max: 268500
Workday Global Grade: 20
Compensation: USD 141,500 - USD 268,500 - yearly
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. The Associate Director provides training and performance management for staff. The Associate Director demonstrates leadership competencies, builds relationships, and promotes teamwork within the Statistical Programming organization and across functions. The Associate Director is accountable for ensuring statistical programming support is delivered across multiple therapeutic areas. The Associate Director makes key recommendations and decisions related to processes, standards, and resource management. The Associate Director is also responsible for staff management and development.
Responsibilities
SAS Programming:
Demonstrates a strong understanding of SAS programming concepts and techniques used in the pharmaceutical industry and applies that knowledge to resolve non-routine problems.
Standards:
Oversees the development and implementation of global company standards for output design and programming conventions and monitors regulatory guidance and industry best practices.
CRFs and Database Definitions:
Provides strategic guidance on CRF and database design and reviews global standards related to these deliverables.
Derivation Programming, Submission Data Sets, and Programs:
Interprets statistical analysis plans, develops analysis data set specifications, and oversees the development and implementation of global standards for derived data sets and submission programs.
Cross-Functional Collaboration:
Works collaboratively with stakeholders to manage priorities and resources across therapeutic areas. Demonstrates a solid understanding of drug development principles, anticipates risks, develops contingency and escalation plans, and contributes to cross-functional initiatives.
Communication:
Presents statistical programming concepts, risk assessments, and recommendations clearly and persuasively to statisticians, scientists, programmers, and non-scientists. Effectively leads meetings and presentations.
Training and Mentoring:
Provides guidance, training, and mentoring to staff to support development and ensure compliance with training requirements.
Staff Management : Assigns responsibilities, defines scope, and reviews progress to ensure projects are delivered on time and with appropriate quality. Allocates resources to maintain the right balance of expertise across projects and collaborates with management to assess staffing needs. Sets high expectations, promotes open communication, and leads staff to meet organizational goals. Provides performance management for 4–10 statistical programmers.
Minimum Qualifications
Degree in Statistics, Computer Science, or a related field
10+ years of statistical programming experience (with MS) OR 12+ years of statistical programming experience (with BS)
Strong technical competence in SAS programming and macro development.
Experience in pharmaceutical clinical trials.
Experience with regulatory filings such as NDA, BLA, or other submissions, including ISS and ISE experience.
Preferred Qualifications
Experience interacting with regulatory agencies, especially FDA and EMEA.
Other Required Skills
Working knowledge of ICH guidelines and relevant regulatory requirements.
Strong oral and written communication skills.
We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.
This job is eligible to participate in our long-term incentive programs.
AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled.
US & Puerto Rico applicants seeking a reasonable accommodation.
#J-18808-Ljbffr