AbbVie

We strive to have a remarkable impact on people's lives across several key therapeutic areas – immunology, oncology, neuroscience, and eye care – and products and services in our Allergan Aesthetics portfolio.. The Associate Director, Statistics provides statistical leadership for clinical development and life-cycle management. Specific areas of work may include clinical trials, patient safety, and global medical. Represent function/department on project team(s) to provide statistical input to compound/drug development. MS (with 10+ years of experience) or PhD (with 6+ years of experience) in Statistics, Biostatistics, or a highly

associate director

Company Description

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 – immunology, oncology, neuroscience, and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn.

Job Description

Purpose:

The Associate Director, Statistics provides statistical 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 Director works in partnership with experts in multiple disciplines to advance medicines to our
patients.

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.
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.

Significant Work Activities -Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)

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.

Additional Information

AbbVie is committed to operating with integrity, driving innovation, transforming lives, serving our community and embracing diversity and inclusion. It is AbbVie’s policy to employ qualified persons of the greatest ability without discrimination against any employee or applicant for employment because of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information, gender identity or expression, sexual orientation, marital status, status as a protected veteran, or any other legally protected group status.

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