The Department of Biometrics 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 pharmacogenetic data from Phase II and Phase III studies and support exposure-response analyses. We have an exciting opportunity for a Director, Statistics - Biometrics based in North Chicago, IL reporting to the Head of Biometrics.
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Leads and directs statistical strategies for multiple therapeutic areas for clinical pharmacology, pharmacokinetics (PK), pharmacodynamics (PD) and early phase pharmaceutical development
Accountable for providing proposals and assessments of statistical strategies; collaborating with representatives from various scientific and operational functions to ensure success of projects for assigned therapeutic area(s)
Also responsible for management and development of staff and for collaborating with management team to lead and build functional area
Through own efforts and those of their staff provides scientific and statistical expertise for clinical pharmacology related plan; 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 outstanding understanding of statistical concepts and methodologies
Takes a leadership role in introducing new/novel statistical methodological approaches into analysis plans which improve 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) or Biometrics 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 all major drug discovery or development projects in assigned therapeutic area(s)
Ensures appropriate functional representation on project teams and adequate statistical resources for projects in assigned therapeutic area(s)
Arranges for and manages alternative resources (i.e., consultants, CROs, interns, temporary staff) to satisfy needs for projects in assigned therapeutic area(s)
Interacts with relevant stakeholders to ensure that appropriate statistical methods are adequately and consistently applied in all scientific and regulatory documents, presentations, and publication
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 in-depth understanding of scientific research designs, worldwide regulatory requirements and commercial aspects of drug development
Ensures regulatory submission documents for all projects in assigned therapeutic area(s) are critically reviewed
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 projects in assigned therapeutic area(s)
Represents DSS or Biometrics 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/Biometrics functional area to ensure timely communication of project team updates, proper statistical strategies, and alignment of priorities between the project team and functional management
May represent DSS or Biometrics on data monitoring committees
Builds/drives inter-department relationships and teamwork
Training, Supervising, Mentoring:
Oversees 1-4 direct reports and 0-18 indirect reports
Develops, coordinates and supervises statistical support for the drug discovery or development programs in assigned therapeutic area(s)
Effectively mentors other development stakeholders with regards to statistical methodology and departmental operations
Responsible for allocating resources within the group, including accurate prediction of future workloads and the ability to maximize statistical productivity within the group, as well as, work effectively with other functional areas
Stimulates the scientific development of staff
Develops and supervises departmental seminars, short courses, and the publication/presentation of scientific articles
Provides coaching and mentoring to first-line managers when needed
Ensures continuous and timely development of staff through internal and external training opportunities
Gains expertise and provides training on innovative statistical methods to staff when necessary
Develops and implements plans and strategies to effectively recruit qualified statisticians to the organization
Provides professional and technical leadership to develop and maintain a highly motivated staff
Ensures that staff and self are compliant with training requirements
Demonstrates a high degree of responsibility in maintaining DSS / Biometrics standards, GxP compliance, and best operating practices for staff and self
Project Coordination / Regulatory Activities:
Plans and coordinates departmental resources to meet therapeutic area priorities
Ensures drug discovery or development programs in assigned therapeutic area(s) incorporate sufficient statistical/scientific rigor and quality to meet stated objectives and global regulatory requirements
Builds relationships between DSS / Biometrics 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 / Biometrics and business objectives
Qualifications
Basic:
M.S./Ph.D. in Statistics, Biostatistics or a related field. At least 8-12 yrs (PhD) or 14-18 yrs (MS) experience in pharmaceutical development and applied statistics/statistical consulting with a minimum of 2 yrs of management experience
In-depth knowledge of statistical methodology and global regulatory requirements, expertise in drug discovery or development, and an understanding of commercial aspects of drug development
Must have demonstrated strong leadership competencies in statistics from planning through implementation and completion
Experience in leading NDA, BLA, and/or CTD submission activities preferred
In-depth knowledge and understanding in application of standard business procedures (regulatory guidance, global regulations, ethical issues associated with scientific research trials, standard operating procedures (SOPs,) etc.)
Experience interacting with regulatory agencies highly desirable
Excellent communication skills, both oral and written
Understands the medical, scientific, operational, regulatory, and technological aspects of a therapeutic area and global implications of statistical strategies, relates these to the internal and external statistical requirements for the project, and directs the implementation of statistical strategies to appropriately address these requirements
Balances the short-term needs of projects with the long-term development of the statistical function
Key Leadership Competencies:
Builds strong relationships with peers and cross functionally with partners outside of team to enable higher performance
Learns fast, grasps the 'essence' and can change the course quickly where indicated
Raises the bar and is never satisfied with the status quo
Creates a learning environment, opens to suggestions and experimentation for improvement
Embraces the ideas of others, nurtures innovation and manges innovation to reality
Significant Work Activities and Conditions
Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)
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