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AbbVie’s mission is to discover and deliver innovative medicines 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: immunology, oncology, neuroscience, eye care, virology, women’s health and gastroenterology, in addition to products and services across its Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn.

Associate Director, Statistics

Irvine, California Req ID 2205494 Category Research and Development Division AbbVie

Job Title: Associate Director, Statistics
Job Grade: 20
Job Code: F1297
Purpose
The Associate Director, Statistics provides statitical leadership for clinical development and life-cycle management
strategies for assigned projects. Specific areas of work may include clinical trials, patient safety, and global medical
affairs. The Associate Diector works in partnership with experts in multiple disciplines to advance medicines to our
patients.
Major Job Responsibilities
• Provide expertise/lead regulatory submission and product life-cycle management strategy planning and
implementation for assigned projects. Provide statistical leadership for design, analysis and reporting for clinical
or other scientific research programs. Independently develop protocols and statistical analysis plans (or product
safety analysis plans/integrated summary of safety analysis plans/analysis plans for GMA evidence generation).
• Represent function/department on project team(s) to provide statistical input to compound/drug development
and drive alignment with functional management. Partner with other functions (Clinical, Regulatory, Patient
Safety, or GMA) to create development strategies for assigned projects.
• Demonstrate extensive understanding of statistical concepts and methodology. Propose novel statistical
methodological approaches to design of scientific studies. Provide sufficient detail to allow programming
implementation. Ensure that all statistical analyses specified in scientific protocols and analysis plans are
conducted appropriately.
• Train and mentor staff on statistical methodology and operations. May supervise contract statisticians or junior
statisticians. Gain expertise in innovative statistical methods. Assist functional leaders in recruiting qualified
personnel and arranging training opportunities for professional development of staff.
• Develop strategy for data presentation and inference. Ensure appropriate interpretation of statistical
deliverables in collaboration with other functions. Collaborate in publication of scientific research. Ensure
accuracy and internal consistency of reports and publications, including tables, listings, and figures.
• Act as the liaison for statistical issues on AbbVie collaborative studies with CROs, academic institutions,
government agencies, steering and/or data monitoring committees, joint ventures or licensing collaborators.
Build external scientific connections which foster professional development and promote the reputation of the
Statistics department.
• (Clin Stat) Ensure that all applicable regulatory requirements for work processes are met. Critically review
regulatory submission documents. Participate in discussions with regulatory agencies as needed. Validate
external statistical software to ensure compliance with SOPs and regulatory requirements.
• (SSG) Lead statistical support for benefit-risk planning and assessment. Provide leadership to the development,
delivery and interpretation of safety outputs, including graphics. Partner with cross-functional team to develop
output specifications to address both pre-planned safety analyses and ad hoc requests.
• (SSG) Lead within the Safety Statistics Group to implement strategic initiatives that address processes related to
interpreting, monitoring, assessing, and reporting safety data to better characterize the safety profile of AbbVie
products, improve efficiencies, and provide greater consistency across therapeutic areas.
• (GMA Stat) Support or lead GMA Statistics group in partnership with GMA, Clinical Research and Clinical Statistics
to develop scientifically appropriate strategies for evidence generation, including GMA studies, presentations,
and publications in assigned therapeutic area(s). Support or lead GMA Statistics to provide functional area input
for life-cycle management of products. Support or lead communications between assigned product team(s) and
functional management. Build/drive cross-functional relationship and collaboration.

Qualifications:

Qualifications
• MS (with 10+ years of experience) or PhD (with 6+ years of experience) in Statistics, Biostatistics, or a highly
related field.
• High degree of technical competence and excellent communication skills, both oral and written
• Able to identify data or analytical issues, and assist with providing solutions by either applying own skills and
knowledge or seeking help from others
• Able to manage project timeline and quality of deliverables
• Able to build strong relationship with peers and cross-functional partners to achieve higher performance.
Highly motivated to drive innovation by raising the bar and challenging the status quo
• Have strong leadership skills and experience in working/managing cross-cultural or oversea teams
• Pharmaceutical or related industry knowledge required, including experience and understanding of drug
development and life-cycle management in the regulated environment.
• (SSG) Experience leading safety-related projects (eg, ISS, benefit-risk assessment, signal detection)
• (GMA Stat) Competence in experimental and RWE study design, descriptive statistics, inferential statistics,
statistical modeling, and statistical programming. Knowledge of methodologies for confounding control and
bias minimization in observational studies preferred.
Key Stakeholders
• Clinical development experts
• Statistical programmers
• Data science experts
• (SSG) Patient safety experts
• (GMA Stat) Global Medical Afairs experts
Additional Information
• This Job description applies to Clinical Statistics (including Phase I statistics in DIVES), Safety Statistics
Group (SSG), and Global Medical Affairs (GMA) Statistics.

Significant Work Activities: N/A
Travel: Yes, 5 % of the Time
Job Type: Experienced
Schedule: Full-time
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