Company Description
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 atย www.abbvie.com. Follow @abbvie onย LinkedIn,ย Facebook,ย Instagram,ย Xย andย YouTube.
Job Description
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 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.
- Provide statistical leadership for design, analysis and reporting for clinical or other scientific research programs. Independently develop protocols and statistical analysis 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.
- 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.
Qualifications
Minimum Qualifications:
- MS (with 10+ years of experience) or PhD (with 6+ years of experience) in Statistics, Biostatistics, or a highly related field.
- Demonstrated depth in statistical methodology and its practical application, with the judgment to identify complex data, design, or analytical issues and develop effective solutions. Knows when to draw on additional expertise and collaborates effectively to resolve challenges.
- Excellent written and oral communication skills, including the ability to explain complex statistical concepts and recommendations clearly to both technical and nontechnical audiences.
- Proven ability to independently lead work across competing priorities, manage project timelines, and deliver high-quality, fit-for-purpose outputs.
- Able to build strong relationships 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.
- Clinical Trial Experience
Preferred Qualifications:
- Immunology clinical trial experience
- PhD in statistics or biostatistics
Additional Information
Applicable only to applicants applying to a position in any location with pay disclosure requirements under state orย local law:ย โ
- The compensation range described below is the range of possible base pay compensation that the Companyย believes inย good faith it will pay for this role at the timeย of this posting based on the job grade for this position.ย Individualย compensation paid within this range will depend on many factors including geographic location, andย weย mayย ultimatelyย payย more or less than the posted range. This range may beย modifiedย in theย future.ย โ
- We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick),ย medical/dental/visionย insurance and 401(k) to eligibleย employees.โ
- This job is eligible toย participateย in our long-term incentiveย programs.
Note: No amount of payย is considered to beย wages or compensation until such amount is earned, vested, andย determinable.ย The amount and availability of any bonus,ย commission, incentive, benefits, or any other form ofย compensation and benefitsย that are allocable to a particular employeeย remainsย in the Company’s sole andย absoluteย discretion unless and until paid andย may beย modifiedย at the Companyโs sole and absolute discretion, consistent withย applicable law.โ
AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community.โฏ Equal Opportunity Employer/Veterans/Disabled.
US & Puerto Rico only - to learn more, visitย https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html
US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:
https://www.abbvie.com/join-us/reasonable-accommodations.html
