Associate Director, Statistics - Immunology
AbbVie
4 months ago
Remote friendly (Florham Park, NJ)
United States
Clinical Research and Development
Responsibilities:
- Provide statistical support for one or more clinical development projects; lead/develop statistical strategy for project development and regulatory submission.
- Provide statistical leadership for design, analysis, and reporting for clinical or scientific research programs; independently develop protocols and statistical analysis plans.
- Represent the statistics function on project teams; provide statistical input to drug development and drive alignment with functional management; partner with Clinical, Regulatory, Patient Safety, and GMA to create development strategies.
- Apply advanced statistical methodology; propose novel methodological approaches; specify details for programming implementation; ensure analyses in protocols/analysis plans are conducted appropriately.
- Train and mentor staff on statistical methodology and operations; may supervise contract or junior statisticians; support recruiting and training for staff development.
- Develop strategy for data presentation and inference; ensure appropriate interpretation of statistical deliverables; collaborate in publication; ensure accuracy and consistency of reports and publications.
- Liaise on statistical issues for collaborative studies with CROs, academics, government agencies, committees, joint ventures, and licensing collaborators.
- Ensure regulatory requirements are met; critically review regulatory submission documents; discuss with regulatory agencies; validate external statistical software for SOP/regulatory compliance.
Significant Work Activities:
- Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8-hr day) is required.
Qualifications:
- MS (10+ years) or PhD (6+ years) in Statistics, Biostatistics, or a related field.
- Strong technical competence and excellent oral/written communication skills.
- Ability to identify data/analytical issues and provide solutions.
- Ability to manage project timelines and deliverable quality.
- Strong relationship-building with peers and cross-functional partners; motivated to drive innovation.
- Strong leadership skills; experience working/managing cross-cultural/overseas teams.
- Pharmaceutical industry knowledge; experience understanding drug development and life-cycle management in regulated environments.
- (SSG) Experience leading safety-related projects (e.g., ISS, benefit-risk assessment, signal detection).
- (GMA Stat) Competence in experimental and RWE study design, descriptive/inferential statistics, statistical modeling, and statistical programming; confounding control and bias minimization methodologies preferred for observational studies.
- Provide statistical support for one or more clinical development projects; lead/develop statistical strategy for project development and regulatory submission.
- Provide statistical leadership for design, analysis, and reporting for clinical or scientific research programs; independently develop protocols and statistical analysis plans.
- Represent the statistics function on project teams; provide statistical input to drug development and drive alignment with functional management; partner with Clinical, Regulatory, Patient Safety, and GMA to create development strategies.
- Apply advanced statistical methodology; propose novel methodological approaches; specify details for programming implementation; ensure analyses in protocols/analysis plans are conducted appropriately.
- Train and mentor staff on statistical methodology and operations; may supervise contract or junior statisticians; support recruiting and training for staff development.
- Develop strategy for data presentation and inference; ensure appropriate interpretation of statistical deliverables; collaborate in publication; ensure accuracy and consistency of reports and publications.
- Liaise on statistical issues for collaborative studies with CROs, academics, government agencies, committees, joint ventures, and licensing collaborators.
- Ensure regulatory requirements are met; critically review regulatory submission documents; discuss with regulatory agencies; validate external statistical software for SOP/regulatory compliance.
Significant Work Activities:
- Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8-hr day) is required.
Qualifications:
- MS (10+ years) or PhD (6+ years) in Statistics, Biostatistics, or a related field.
- Strong technical competence and excellent oral/written communication skills.
- Ability to identify data/analytical issues and provide solutions.
- Ability to manage project timelines and deliverable quality.
- Strong relationship-building with peers and cross-functional partners; motivated to drive innovation.
- Strong leadership skills; experience working/managing cross-cultural/overseas teams.
- Pharmaceutical industry knowledge; experience understanding drug development and life-cycle management in regulated environments.
- (SSG) Experience leading safety-related projects (e.g., ISS, benefit-risk assessment, signal detection).
- (GMA Stat) Competence in experimental and RWE study design, descriptive/inferential statistics, statistical modeling, and statistical programming; confounding control and bias minimization methodologies preferred for observational studies.