AbbVie

Director, Statistics (Remote Option)

Employer
AbbVie
Location
Working from home
Posted
Jul 28, 2021
Ref
2102573
Required Education
Doctorate/PHD/MD
Position Type
Contract
About AbbVie
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.

Purpose
The Director, Statistics provides scientific and statitical leadership for assigned clinical development projects. A visible
and collaborative role, the Diector works in partnership with clinical and regulatory experts to advance medicines to
our patients.
Major Job Responsibilities
• Lead the statistical support for one or more clinical development projects through own efforts or those of a
team. Lead/develop statistical strategy for project development and regulatory submission.
• Direct or provide statistical leadership for design, analysis and reporting for clinical or other scientific research
programs. Lead the development of protocols, statistical analysis plans, and statistical programming plan.
• 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. May 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.
• Guide 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 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 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. May represent DSS in discussions with regulatory agencies. Validate external statistical
software to meet SOPs and regulatory requirements.MS (with 12+ years of experience) or PhD (with 8+ 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 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.
Key Stakeholders
• Clinical development experts
• Statistical programmers
• Data science experts
• Global Medical Affairs experts
• Regulatory experts


Qualifications

MS (with 12+ years of experience) or PhD (with 8+ 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 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.
Key Stakeholders
• Clinical development experts
• Statistical programmers
• Data science experts
• Global Medical Affairs experts
• Regulatory experts


Significant Work Activities
Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)
Travel
Yes, 10 % of the Time
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.