Director, Statistics II - Oncology (Office-based)

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 X, Facebook, Instagram, YouTube, LinkedIn and Tik Tok.

Job Description

The Director, Statistics II, Oncology provides scientific and statistical leadership for assigned clinical development projects. A highly empowered, visible and collaborative role, the Director works in partnership with clinical and regulatory experts to advance medicines to our patients.

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 programming 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.

Significant Work Activities

Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hr day) is required

Qualifications

Additional Information

Note : No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole and absolute discretion unless and until paid and may be modified at the Company's sole and absolute discretion, consistent with applicable law.

AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer / Veterans / Disabled.

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