Job Description

About AbbVie
AbbVies 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 peoples lives across several key therapeutic areas: immunology, oncology, neuroscience, eye care, virology, womens 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.

Introduction:

The Director, Statistics provides scientific and statistical leadership for assigned clinical development projects. A highly empowered, visible and collaborative role, the Diector works in partnership with clinical and regulatory experts to advance medicines to our patients. This role will support multiple GI Programs.

Responsibilities:

* Lead the statistical support for one or more clinical development projects through own efforts or those of a team. Lead statistical strategy for project development and regulatory submission.
* Direct and review the development of design, analysis and reporting for clinical or other scientific research programs. Review protocols, statistical analysis plans, and statistical programing plans.
* 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. Represent DSS on data monitoring committees. Build interdepartmental relationships.
* 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.
* Lead strategy and direct development and implementation of project-specific database-related activities in collaboration with Data Sciences, Statistical Programming and other stakeholders.
* Train and mentor staff on statistical methodology and operations. May supervise a group of statisticians as a people manager. 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 activities. 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. Represent DSS in discussions with regulatory agencies and on Advisory Committees.
Develop an external presence within the statistics community and represent abbvie on advanced and emerging topics.

Qualifications
* MS (with a minimum of 14 years of experience) or PhD (with a minimum of 10 years of experience) in Statistics, Biostatistics, or a highly related field.
* Excellent English communication skills, both oral and written.
* Advanced knowledge of statistical methodology including experimental design, descriptive statistics, inferential statistics, statistical modeling, and statistical programming. Must have demonstrated exemplary statistical experience in managing and completing multiple projects or equivalent experience.
* At least 14 years (MS) or 10 years (PhD) of experience in pharmaceutical development. Experience in leading NDA, BLA, and or CTD submission preferred (for clinical statistics only). In-depth knowledge and understanding in application of standard business procedures (regulatory guidance, global regulations, ethical issues associated with scientific research trials, SOPs, etc.). Experience interacting with regulatory agencies.
* Minimum of 2 years of management experience required for people managers.

Significant Work Activities
N/A
Travel
No
Job Type
Experienced
Schedule
Full-time
Job Level Code
D
Equal Employment Opportunity
At AbbVie, we value bringing together individuals from diverse backgrounds to develop new and innovative solutions for patients. As an equal opportunity employer we do not discriminate on the basis 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, protected veteran status, or any other legally protected characteristic.