Associate Director - Statistics, Specialty TA (Hybrid)

AbbVie; Irvine (CA); On-site; USD 150,000 - 190,000; Full time

Benefits offered by this job

Paid time off

Medical/dental/vision insurance

401(k)

Long-term incentive programs

Job summary

AbbVie is seeking an Associate Director, Statistics to provide statistical leadership for clinical development and lifecycle management strategies. You will collaborate with cross-functional teams to advance medicines, lead design and analysis, and guide regulatory submissions.

The role emphasizes mentoring staff, developing innovative statistical approaches, and ensuring accuracy across reports and publications.

Qualifications

• MS with 10+ years, or PhD with 6+ years in Statistics or Biostatistics.
• Pharmaceutical industry knowledge and drug development experience are required.
• PhD is preferred for advanced research leadership.

Responsibilities

• Provide statistical leadership for design, analysis, and reporting of clinical programs.
• Lead regulatory submission and product life-cycle management strategy planning.
• Mentor staff and oversee contract statisticians; collaborate with cross-functional teams.

Skills

Statistical leadership

Cross-functional leadership

Biostatistics knowledge

Regulatory knowledge

Communication skills

Education

MS or PhD in Statistics/Biostatistics

PhD preferred

Job 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 at www.abbvie.com. Follow @abbvie on LinkedIn, Facebook, Instagram, X and YouTube.

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 at www.abbvie.com. Follow @abbvie on LinkedIn, Facebook, Instagram, X and 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 expertise/lead regulatory submission and product life-cycle management strategy planning and implementation for assigned projects. 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.
• 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.

Preferred Qualifications:

• PhD preferred
• Submission experience preferred

Other Required Skills:

• High degree of technical competence and excellent communication skills, both oral and written
• Able to identify data or analytical issues, and assist with providing solutions by either applying own skills and knowledge or seeking help from others
• Able to manage project timeline and quality of deliverables
• Able to build strong relationship with peers and cross-functional partners to achieve higher performance. Highly motivated to drive innovation by raising the bar and challenging the status quo

Additional Information

• The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more or less than the posted range. This range may be modified in the future.
• We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.
• This job is eligible to participate in our long-term incentive programs.

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.

US & Puerto Rico only - to learn more, visit 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