Director, Statistics
The Director of Statistics provides scientific and statistical leadership for assigned clinical development projects. A visible and collaborative role, the Director works in partnership with clinical and regulatory experts to advance medicines to our patients. Major Job Responsibilities
Provide statistical expertise and support for one or more clinical development projects through own efforts or those of a team; lead/develop statistical strategy for project development and regulatory submissions
Plan, direct and organize all statistical activities for the assigned projects including study protocol development, statistical methods, data analysis and interpretations; make sure clinical trials are optimally designed, properly analyzed and clearly presented to support new product development, regulatory submissions and the maintenance and growth of existing products
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; may represent DSS on Data Monitoring Committees; build interdepartmental relationships
Demonstrate in-depth understanding of statistical concepts and broad knowledge in methodologies; propose novel statistical methodological approaches to design of scientific studies; gain expertise in innovative statistical methods
Provide sufficient detail to allow programming implementation; ensure that all statistical analyses specified in study protocols and analysis plans are scientifically sound and executed appropriately.
Guide development and implementation of project-specific database-related activities in collaboration with Data Sciences, Statistical Programming, and other stakeholders
Manage resources and timeline to ensure that statistical deliverables are generated with high quality and completed by the agreed timeline; ensure accuracy and internal consistency of reports and publications, including tables, listings, and figures following department standards
Train and mentor staff on statistical methodology and operations
Develop strategy for data presentation and inference; ensure appropriate interpretation of statistical deliverables in collaboration with other functions; collaborate with team for publications of scientific research
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 activities; build external scientific connections which foster professional development and promote the reputation of the statistics department
Ensure that work processes follow all applicable regulatory requirements; conduct critical review of regulatory submission documents; may represent DSS in discussions with regulatory agencies.
Salary Range:
$200K -- $500K+
Minimum Qualification
Life SciencesEstimated Salary: $20 to $28 per hour based on qualifications.
Provide statistical expertise and support for one or more clinical development projects through own efforts or those of a team; lead/develop statistical strategy for project development and regulatory submissions
Plan, direct and organize all statistical activities for the assigned projects including study protocol development, statistical methods, data analysis and interpretations; make sure clinical trials are optimally designed, properly analyzed and clearly presented to support new product development, regulatory submissions and the maintenance and growth of existing products
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; may represent DSS on Data Monitoring Committees; build interdepartmental relationships
Demonstrate in-depth understanding of statistical concepts and broad knowledge in methodologies; propose novel statistical methodological approaches to design of scientific studies; gain expertise in innovative statistical methods
Provide sufficient detail to allow programming implementation; ensure that all statistical analyses specified in study protocols and analysis plans are scientifically sound and executed appropriately.
Guide development and implementation of project-specific database-related activities in collaboration with Data Sciences, Statistical Programming, and other stakeholders
Manage resources and timeline to ensure that statistical deliverables are generated with high quality and completed by the agreed timeline; ensure accuracy and internal consistency of reports and publications, including tables, listings, and figures following department standards
Train and mentor staff on statistical methodology and operations
Develop strategy for data presentation and inference; ensure appropriate interpretation of statistical deliverables in collaboration with other functions; collaborate with team for publications of scientific research
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 activities; build external scientific connections which foster professional development and promote the reputation of the statistics department
Ensure that work processes follow all applicable regulatory requirements; conduct critical review of regulatory submission documents; may represent DSS in discussions with regulatory agencies.
Salary Range:
$200K -- $500K+
Minimum Qualification
Life SciencesEstimated Salary: $20 to $28 per hour based on qualifications.
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