Associate Director, Statistics - Immunology (Hybrid)

AbbVie; North Chicago (IL); Sur place; USD 140 000 - 230 000; Plein temps

Résumé du poste

AbbVie is seeking an Associate Director of Statistics to provide statistical leadership across clinical development and lifecycle management. You will guide design, analysis, reporting, and regulatory submissions while collaborating with Clinical, Regulatory, Patient Safety, and GMA teams.

The role requires deep statistical expertise, leadership of cross-functional teams, and the ability to mentor staff. You will influence study design and data interpretation, ensuring high quality outputs and

Qualifications

• MS (with 10+ years of experience) or PhD (with 6+ years in statistics/biostatistics)
• Strong leadership skills and experience in cross-cultural or overseas teams
• Pharmaceutical knowledge including drug development and life-cycle management in a regulated environment

Responsabilités

• Provide statistical leadership for regulatory submission and product lifecycle management strategy planning and implementation.
• Represent function on project teams to provide statistical input and align with management.
• Demonstrate understanding of statistical concepts; propose novel methods and ensure analyses follow protocols.
• Train and mentor staff on statistical methods and operations; may supervise junior statisticians.
• Develop data presentation strategy and ensure accurate, well-interpreted deliverables.
• Act as liaison for statistical issues on AbbVie collaborations with CROs and partners.
• Ensure regulatory compliance and review submission documents; validate external software.

Connaissances

Leadership

Cross-cultural teams

Statistical methods

Communication skills

Project management

Regulatory submissions

Formation

MS in Statistics/Biostatistics or related (10+ years)

PhD in Statistics/Biostatistics or related (6+ years)

Description du poste

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 (or product safety analysis plans/integrated summary of safety analysis plans/analysis plans for GMA evidence generation).
• 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 knowledge required, including experience and understanding of drug development and life-cycle management in the regulated environment.

Preferred Qualifications

• Experience with late-stage clinical trials and/or submissions
• Experience with immunology clinical trials

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