Join to apply for the Director, Statistics (Office-based) role at BioSpace Company: AbbVie (via BioSpace) Overview The Director, Statistics provides scientific and statistical leadership for assigned clinical development projects. The role is visible and collaborative, working in partnership with clinical and regulatory experts to advance medicines to patients. This position will work a hybrid schedule (3 days in office; 2 days remote) from the Lake County, IL or Florham Park, NJ offices. Responsibilities

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Lead the statistical support for one or more clinical development projects, through own efforts or a team, and develop statistical strategy for project development and regulatory submission.

Provide statistical leadership for design, analysis and reporting for clinical or other scientific research programs. Develop protocols, statistical analysis plans, and statistical programming plans.

Represent the function on project teams and drive alignment with functional management. Partner with Clinical, Regulatory, Patient Safety, and other functions to create development strategies. May represent DSS on data monitoring committees. Build interdepartmental relationships.

Demonstrate extensive understanding of statistical concepts; propose novel methodological approaches and ensure analyses follow protocols and analysis plans.

Guide 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 or junior statisticians. Support recruiting and professional development.

Develop data presentation and inference strategy; ensure accurate interpretation of statistical deliverables and collaboration with other functions. Contribute to publications and ensure accuracy of reports, tables, listings and figures.

Act as liaison for statistical issues on AbbVie collaborative studies with CROs, academic institutions, government agencies, and other partners. Build external scientific connections to foster the Statistics department's reputation.

Ensure regulatory requirements for work processes are met. Review regulatory submission documents; may represent DSS in discussions with regulatory agencies. Validate external statistical software to meet SOPs and regulatory requirements.

Qualifications

MS (with 12+ years of experience) or PhD (with 8+ years of experience) in Statistics, Biostatistics, or related field.

High technical competence and excellent communication skills (oral and written).

Ability to identify data or analytical issues and develop solutions; ability to build strong cross-functional relationships; motivated to drive innovation.

Strong leadership skills with experience managing cross-cultural or overseas teams.

Pharmaceutical or related industry knowledge, including drug development and lifecycle management in a regulated environment.

Additional Information

Compensation and benefits include base pay ranges disclosed where applicable and a comprehensive package of benefits (paid time off, medical/dental/vision, 401(k)); eligibility for short- and long-term incentive programs.

Equal Opportunity Employer; Veterans/Disabled. Location-specific pay disclosures and accommodations information available as applicable.

Location: Lake County, IL or Florham Park, NJ (hybrid)

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