The Senior Manager, Statistics provides statistical leadership to support the research and development organization for assigned projects. Specific areas of work may include clinical trials, patient safety, and global medical affairs. The Senior Manager works independently in partnership with experts in multiple disciplines to advance medicines to our patients.
Major Job Responsibilities
• Support regulatory submission and product life-cycle management strategy planning and implementation. 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). Work independently to implement sound statistical methodology in scientific investigations.
• Represent the function on project team(s) to provide functional area input to asset development.
• Lead in identifying scientifically appropriate data collection instruments. Provide programming specifications for derived variables and analysis datasets. Guide Data Science and other functions in preparing for database lock. Ensure accuracy of data released for statistical analysis.
• Independently perform statistical analyses as per the analysis plan. Collaborate with Statistical Programming to ensure the delivery of high-quality outputs according to agreed-upon timelines. Identify and anticipate issues arising in the study design, conduct and propose scientifically sound approaches. Evaluate appropriateness of available software for planned analyses and assess needs for potential development of novel statistical methodology.
• 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.
• Work collaboratively with multifunction teams per agreed timelines. Clearly explain statistical concepts to nonstatisticians. Provide responses to questions from clients and pursue analyses suggested by data under supervision. Support communications between assigned product team(s) and functional management. Build/drive cross-functional relationships and collaboration.
• (SSG) Lead statistical support for benefit-risk planning and assessment. Partner with cross-functional team to develop output specifications to address both pre-planned safety analyses and ad hoc requests.
• (SSG) Lead within the Safety Statistics Group to implement strategic initiatives that address processes related to interpreting, monitoring, assessing, and reporting safety data to better characterize the safety profile of AbbVie products, improve efficiencies, and provide greater consistency across therapeutic areas.
• (GMA Stat) Support or lead GMA Statistics group in partnership with GMA, Clinical Research and Clinical Statistics to develop scientifically appropriate strategies for evidence generation, including GMA studies, presentations, and publications in assigned therapeutic area(s). Support or lead GMA Statistics to provide functional area input for life cycle management of products. Support or lead communications between assigned product team(s) and functional management. Build/drive cross-functional relationship and collaboration.
• MS (with 8+ years of experience) or PhD (with 4+ years of experience) in Statistics, Biostatistics, or a highly related field.
• High degree of technical competence and effective 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
• Have strong leadership skills and experience in working/managing cross-cultural or oversea teams
• Pharmaceutical or related industry knowledge desired, including experience and understanding of drug development and life-cycle management in the regulated environment.
• (SSG) Some experience supporting safety-related projects (eg, ISS, benefit-risk assessment, signal detection) is preferred
• (GMA Stat) Competence in experimental and RWE study design, descriptive statistics, inferential statistics, statistical modeling, and statistical programming. Knowledge of methodologies for confounding control and bias minimization in observational studies preferred.
• Clinical development experts
• Statistical programmers
• Data science experts
• (SSG) Patient safety experts
• (GMA Stat) Global Medical Afairs experts
• This Job description applies to Clinical Statistics (including Phase I statistics in DIVES), Safety Statistics Group (SSG), and Global Medical Affairs (GMA) Statistics.
Significant Work Activities: N/A
Travel: Yes, 5 % of the Time
Job Type: Experienced