Associate Director - Statistical Programming (Hybrid)

AbbVie•North Chicago, CA

3d•Hybrid

About The Position

About AbbVie AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com . Follow @abbvie on LinkedIn, Facebook , Instagram , X and YouTube. Job Description 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.

Requirements

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.
Working knowledge of ICH guidelines and relevant regulatory requirements.
Strong oral and written communication skills.

Nice To Haves

Experience interacting with regulatory agencies, especially FDA and EMEA.
Previous management experience.

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.