Associate Director, Clinical Pharmacology Statistics

In AbbVie DSS (Data and Statistical Science), Department of Discovery and Early Pipeline Statistics has responsibility for Statistics of the clinical pharmacology aspects of drug development. This comprises the statistical aspect of study designs and data analyses from Phase I studies, including pharmacokinetic and bioequivalence/bioavailability studies, pharmacodynamics, QT/QTc studies, and the earliest studies in humans. In addition, the Department analyzes the pharmacokinetic and pharmacodynamic data from Phase II and Phase III studies and support exposure-response analyses. We have an exciting opportunity for an Associate Director, Statistics, based in North Chicago, IL.

Key Responsibilities:

• Provides scientific and statistical expertise through own efforts and those of her/his staff (if appropriate) for drug discovery or development strategies for assigned project; for the design, analysis, and reporting of scientific research trials; and for interacting with regulatory agencies regarding the results of these activities.

Protocol Development:

• Directs the development of scientific protocols, ensuring they are scientifically sound and make optimal use of the data to be collected
• Ensures research hypotheses and corresponding study designs are aligned with the project strategy, and meet scientific and/or regulatory needs
• Ensures statistical methodology is appropriate and sound, consistent with the objective(s) of the scientific protocol

Database Activities:

• In collaboration with Data Sciences, Statistical Programming and other stakeholders, ensures data collection instruments are designed to capture protocol-specified scientific information and study databases (e.g., SAS, MS Access, Excel) are implemented such that short- and long-term project needs can be achieved
• Oversees or partners in development of data quality assurance checks, ensuring accuracy and consistency of data released for statistical analysis

Statistical Analyses:

• Demonstrates extensive understanding of statistical concepts and methodologies
• Proposes new/novel statistical methodological approaches leading to improvements in the efficiency and sensitivity of study results
• Provides sufficient detail to allow programming implementation
• Ensures that all the statistical analyses specified in scientific protocols and/or analysis plans are conducted appropriately

Scientific Reports and Publications:

• Ensures that study results and conclusions are scientifically sound, clearly presented, and supported by the statistical analyses provided
• Prepares oral and written reports to effectively communicate results of clinical/scientific research to AbbVie management, project teams, regulatory agencies, or individual investigators
• Represents Data and Statistical Sciences (DSS) on project issues at management review meetings and project team meetings
• Provides in-depth scientific/statistical review for scientific reports and publications
• Ensures the accuracy of the statistical component of scientific reports and/or publications with high quality

Consultation:

• Partners with multiple stakeholders to develop scientifically appropriate development strategies for assigned drug discovery or development project
• Effectively plans and coordinates statistical resources to best meet assigned project priorities
• Works with Senior Director and appropriate administrative staff to manage alternative resources (i.e., consultants, CROs, interns, temporary staff) to satisfy needs for assigned project
• Interacts with relevant stakeholders to ensure that appropriate statistical methods are adequately and consistently applied in all scientific and regulatory documents, presentations, and publications
• Provides scientific/statistical insight in addressing questions from clients, and proposes novel solutions to technical issues
• Independently pursues analyses suggested by the data, including the pursuit of statistical knowledge needed to address the scientific issue
• In collaboration with Statistical Programming or their designee, ensures that all internal and external statistical software used in the performance of analyses defined in SAPs or scientific research plans are efficient, validated, and meet internal SOPs and external regulatory requirements
• Acts as the liaison for statistical issues on AbbVie collaborative studies with outside universities, government agencies, steering and/or data monitoring committees, joint ventures or licensing activities
• Builds external scientific contacts which foster professional development and promote the reputation of the department
• Demonstrates good understanding of scientific research designs, worldwide regulatory requirements and commercial aspects of drug development
• Critically reviews regulatory submission documents for assigned drug discovery or drug development project
• Effectively and persuasively presents statistical concepts, evidence, interpretations, and logical arguments to the project team, management, regulatory agencies, and scientists

Project Team Involvement:

• Partners with Clinical and Regulatory to develop scientifically appropriate development strategies for assigned project
• Represents DSS on project team(s) to provide functional area input to compound/drug development and ensures alignment with functional management
• Leads the communication between assigned project team(s) and DSS functional area to ensure timely communication of project team updates, proper statistical strategies, and alignment of priorities between the project team and functional management

Training, Supervising, Mentoring:

• In conjunction with Director and/or Senior Director, coordinates statistical support for assigned drug discovery or development project
• Effectively mentors other development stakeholders with regards to statistical methodology and departmental operations
• Mentors and/or manages personnel when appropriate by delegating assignments, reviewing activities and defining/ensuring review of deliverables so that projects are completed on time with high quality
• Fosters the scientific development of staff
• Participates in department seminars, short courses, and the publication presentation of scientific articles
• Works with Director and/or Senior Director to arrange training opportunities for staff to facilitate their timely career development
• Works with Senior Director and/or appropriate administrative management to recruit qualified statisticians to the organization
• Ensures that staff (if appropriate) and self are compliant with training requirements. Demonstrates a high degree of responsibility in maintaining DSS standards, GxP compliance, and best operating practices for staff (if appropriate) and self

Project Coordination / Regulatory Activities:

• Coordinates statistical resources within and across sites to effectively utilize resources
• Reviews key decisions impacting project timelines with department management
• Has a strategic focus on assigned drug discovery or development project and optimizes execution
• Works with Senior Director to build relationships between DSS and outside investigators and medical/scientific experts
• Ensures that all applicable regulatory requirements for work processes are met
• Participates in discussions with regulatory agencies as needed
• Consistently demonstrates excellent record of achievement with respect to DSS and business objectives

Basic Qualifications:

• M.S./Ph.D. in Statistics, Biostatistics or a related field
• At least 6 yrs (PhD) or 10 yrs (MS) experience in pharmaceutical development and applied statistics/statistical consulting
• Project lead experience required
• Broad knowledge of statistical methodology and global regulatory requirements, expertise in drug discovery or development, and an understanding of commercial aspects of drug development
• Experience interacting with regulatory agencies highly desirable
• Excellent communication skills, both oral and written
• Jointly with other project team members, develops and evaluates options for meeting project team goals under time and resource constraints
• Proposes and evaluates options for responding to questions from internal and external sources, including regulatory agencies
• Implements the agreed upon solution after discussion with other stakeholders. Identifies opportunities for, and leads teams for process improvement initiatives
• Actively participates in risk assessment and development of contingency plans
• Productive in relevant statistical research and problem solving

Equal Opportunity Employer Minorities/Women/Veterans/Disabled