Senior Statistics Leader, Clinical Development

AbbVie; South San Francisco (CA); On-site; USD 150,000 - 230,000; Full time

Job summary

The Associate Director, Statistics at AbbVie provides statistical leadership for clinical development and life-cycle management strategies for assigned projects across trials, safety, and medical affairs. You will collaborate with cross-functional teams to advance medicines to patients.

You will design studies, develop SAPs, lead statistical analyses, mentor staff, and ensure rigorous reporting of results in publications and submissions in compliance with regulatory requirements.

Qualifications

• MS in Statistics/Biostatistics with 10+ years experience or PhD with 6+ years
• Strong expertise in statistical methodology and regulatory science
• Excellent written and oral communication skills
• Proven ability to independently lead work across competing priorities
• Experience in pharmaceutical drug development and life-cycle management

Responsibilities

• Provide statistical leadership for project development and regulatory submission strategies.
• Develop protocols and SAPs; lead design, analysis and reporting of trials.
• Collaborate with Clinical, Regulatory, and Patient Safety teams to align development plans.
• Propose novel statistical approaches and ensure analyses follow protocols and SOPs.
• Mentor junior staff and possibly supervise contract statisticians.
• Ensure accurate data presentation and publication readiness.
• Represent statistics in external collaborations with CROs and partners.

Skills

Statistical methodology

Communication skills

Project leadership

Cross-functional collaboration

Clinical trial experience

Leadership

Education

MS/PhD in Statistics/Biostatistics

Job description

The Associate Director, Statistics at AbbVie provides statistical leadership for clinical development and life-cycle management strategies for assigned projects across trials, safety, and medical affairs. You will collaborate with cross-functional teams to advance medicines to patients.

You will design studies, develop SAPs, lead statistical analyses, mentor staff, and ensure rigorous reporting of results in publications and submissions in compliance with regulatory requirements.