BioSpace
Overview
Associate Director, Statistics - On-site AbbVie is seeking a statistics leader to provide statistical leadership for clinical development and life-cycle management strategies for assigned projects, including clinical trials, patient safety, and global medical affairs. The role collaborates with experts across disciplines to advance medicines to patients. Local candidates in Lake County, IL; San Francisco, CA; Irvine, CA; or Florham Park, NJ are expected to work hybrid. Responsibilities
Provide expertise and leadership for regulatory submission and product life-cycle management strategy planning and implementation for assigned projects. Lead design, analysis and reporting for clinical or other scientific research programs. Independently develop protocols and statistical analysis plans (or product safety analysis plans/integrated safety analysis plans/analysis plans for evidence generation). Represent the statistics function on project teams, providing statistical input to development and aligning with functional management. Partner with Clinical, Regulatory, Patient Safety, and GMA to create development strategies for assigned projects. Demonstrate extensive understanding of statistical concepts and methodology. Propose novel statistical methodological approaches for study design. Provide sufficient detail for programming implementation. Ensure all analyses in protocols and analysis plans are conducted appropriately. Train and mentor staff on statistical methodology and operations. May supervise contract statisticians or junior statisticians. Develop expertise in innovative statistical methods and assist functional leaders in recruiting and training opportunities for staff development. Develop strategy for data presentation and inference. Ensure accurate interpretation of statistical deliverables in collaboration with other functions. Contribute to publication of scientific research and ensure accuracy and internal consistency of reports including tables, listings, and figures. Serve as 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 to foster professional development and promote the Statistics department's reputation. (Clinical Statistics) Ensure compliance with applicable regulatory requirements for work processes. Critically review regulatory submission documents. Participate in discussions with regulatory agencies as needed. Validate external statistical software to ensure SOP and regulatory compliance. Qualifications
MS (with 10+ years of experience) or PhD (with 6+ years of experience) in Statistics, Biostatistics, or a closely related field. High degree of technical competence and excellent oral and written communication skills. Ability to identify data or analytical issues and provide solutions, using own skills or collaborating with others. Ability to manage project timelines and deliverable quality. Ability to build strong cross-functional relationships and drive innovation. Strong leadership skills with experience managing cross-cultural or overseas teams. Pharmaceutical or related industry knowledge, including drug development and life-cycle management in a regulated environment. Additional Information
The compensation range described is a range of possible base pay compensation the Company believes in good faith it will pay for this role, based on job grade. Individual compensation within this range will depend on factors including geographic location and the Company may pay more or less than the posted range. This range may be modified in the future. We offer a comprehensive benefits package including paid time off, medical/dental/vision insurance, and 401(k) to eligible employees. This job is eligible to participate in short-term incentive programs and long-term incentive programs. Note: No amount of pay is considered wages or compensation until earned, vested, and determinable. Bonus, incentives, benefits, and other compensation may be discretionary and subject to change. AbbVie is an equal opportunity employer and is committed to integrity, innovation, and serving the community. Equal Opportunity Employer/Veterans/Disabled.
US & Puerto Rico only: learn more about equal employment opportunity and accommodations at the provided links: https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html https://www.abbvie.com/join-us/reasonable-accommodations.html
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Associate Director, Statistics - On-site AbbVie is seeking a statistics leader to provide statistical leadership for clinical development and life-cycle management strategies for assigned projects, including clinical trials, patient safety, and global medical affairs. The role collaborates with experts across disciplines to advance medicines to patients. Local candidates in Lake County, IL; San Francisco, CA; Irvine, CA; or Florham Park, NJ are expected to work hybrid. Responsibilities
Provide expertise and leadership for regulatory submission and product life-cycle management strategy planning and implementation for assigned projects. Lead design, analysis and reporting for clinical or other scientific research programs. Independently develop protocols and statistical analysis plans (or product safety analysis plans/integrated safety analysis plans/analysis plans for evidence generation). Represent the statistics function on project teams, providing statistical input to development and aligning with functional management. Partner with Clinical, Regulatory, Patient Safety, and GMA to create development strategies for assigned projects. Demonstrate extensive understanding of statistical concepts and methodology. Propose novel statistical methodological approaches for study design. Provide sufficient detail for programming implementation. Ensure all analyses in protocols and analysis plans are conducted appropriately. Train and mentor staff on statistical methodology and operations. May supervise contract statisticians or junior statisticians. Develop expertise in innovative statistical methods and assist functional leaders in recruiting and training opportunities for staff development. Develop strategy for data presentation and inference. Ensure accurate interpretation of statistical deliverables in collaboration with other functions. Contribute to publication of scientific research and ensure accuracy and internal consistency of reports including tables, listings, and figures. Serve as 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 to foster professional development and promote the Statistics department's reputation. (Clinical Statistics) Ensure compliance with applicable regulatory requirements for work processes. Critically review regulatory submission documents. Participate in discussions with regulatory agencies as needed. Validate external statistical software to ensure SOP and regulatory compliance. Qualifications
MS (with 10+ years of experience) or PhD (with 6+ years of experience) in Statistics, Biostatistics, or a closely related field. High degree of technical competence and excellent oral and written communication skills. Ability to identify data or analytical issues and provide solutions, using own skills or collaborating with others. Ability to manage project timelines and deliverable quality. Ability to build strong cross-functional relationships and drive innovation. Strong leadership skills with experience managing cross-cultural or overseas teams. Pharmaceutical or related industry knowledge, including drug development and life-cycle management in a regulated environment. Additional Information
The compensation range described is a range of possible base pay compensation the Company believes in good faith it will pay for this role, based on job grade. Individual compensation within this range will depend on factors including geographic location and the Company may pay more or less than the posted range. This range may be modified in the future. We offer a comprehensive benefits package including paid time off, medical/dental/vision insurance, and 401(k) to eligible employees. This job is eligible to participate in short-term incentive programs and long-term incentive programs. Note: No amount of pay is considered wages or compensation until earned, vested, and determinable. Bonus, incentives, benefits, and other compensation may be discretionary and subject to change. AbbVie is an equal opportunity employer and is committed to integrity, innovation, and serving the community. Equal Opportunity Employer/Veterans/Disabled.
US & Puerto Rico only: learn more about equal employment opportunity and accommodations at the provided links: https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html https://www.abbvie.com/join-us/reasonable-accommodations.html
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