Senior Statistics Leader, Clinical Development

AbbVie; New Jersey; On-site; USD 170,000 - 250,000; Full time

Job summary

AbbVie is seeking an Associate Director, Statistics to lead statistical strategy for clinical development and lifecycle programs. You will guide trial design, analysis, and reporting while partnering with Clinical, Regulatory, Patient Safety, and GMA teams.

The role demands extensive statistical expertise, leadership of cross-functional teams, and experience in drug development within a regulated environment. Strong communication and mentoring skills are essential.

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; identifies complex data/design issues and develops solutions.
• Excellent written and oral communication; explains statistics clearly to technical and nontechnical audiences.
• Proven ability to independently lead work across competing priorities and timelines; delivers high-quality outputs.
• Strong leadership; builds cross-functional relationships and drives innovation.
• Experience in managing cross-cultural or overseas teams; collaboration across functions.
• Pharmaceutical or related industry knowledge including drug development and life-cycle management in a regulated environment.
• Clinical Trial Experience

Responsibilities

• Provide statistical leadership for clinical development projects and regulatory submissions.
• Lead design, analysis and reporting for clinical or scientific research programs; develop protocols and analysis plans.
• Represent statistics on project teams; collaborate with Clinical, Regulatory, Patient Safety, and GMA to shape development strategies.
• Demonstrate understanding of statistical concepts; propose novel methods and ensure analyses follow protocols.
• Train and mentor staff; may supervise contract/statistical personnel.
• Develop data presentation strategy; ensure accurate interpretation of deliverables in reports and publications.
• Act as liaison for statistical issues with CROs, academic partners, and regulators; build external scientific connections.
• Ensure compliance with regulatory requirements and SOPs; review regulatory submission documents

Skills

Statistical leadership

Clinical development

Regulatory submission

Mentoring staff

Education

MS in Statistics/Biostatistics

PhD in Statistics/Biostatistics

Job description

AbbVie is seeking an Associate Director, Statistics to lead statistical strategy for clinical development and lifecycle programs. You will guide trial design, analysis, and reporting while partnering with Clinical, Regulatory, Patient Safety, and GMA teams.

The role demands extensive statistical expertise, leadership of cross-functional teams, and experience in drug development within a regulated environment. Strong communication and mentoring skills are essential.