Director Safety Statistics

The Safety Statistics Group (SSG) at AbbVie is an important strategic part of Data and Statistical Sciences (DSS). Safety Statisticians are part of collaborative, cross functional teams including members from Pharmacovigilance and Patient Safety (e.g, product safety team physicians, epidemiologists, and safety analysts), Statistical Programming, Clinical Statistics, Regulatory Affairs, and Medical Writing. Safety Statisticians work on products in the AbbVie portfolio ranging from early to later stages of development and life cycle management, with a focus on evaluation, interpretation, and reporting of aggregate/integrated safety data, including benefit risk planning and assessment.

We have an exciting opportunity for a Director or Associate Director , Safety Statistics, depending on experience, based in North Chicago, IL reporting to the Director, Safety Statistics.

• Provides strategiesstrategic input to and oversight of the development of Product Safety Statistical Analysis Plans (PSSAPs) and Integrated Summary of Safety Statistical Analysis Plans (ISS SAPs), benefit-risk planning and assessment, data integration and output specifications to address pre-planned and ad hoc safety analyses, safety related regulatory submissions, and responses to regulatory requests, including attending regulatory meetings; responsible for project and resource management within SSG for therapeutic area(s) of responsibility;

Statistical Analyses:

• Demonstrates outstanding understanding of statistical concepts and methodologies

• Proposes new/novel statistical methodological approaches leading to improvements in the efficiency and sensitivity of 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 thatresults 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 SSG 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 one or more major drug discovery or development projects

• Effectively plans and manages statistical resources to meet assigned project priorities

• Works with Director and appropriate administrative staff to arrange for and manage alternative resources (i.e., consultants, CROs, interns, temporary staff) to satisfy needs of assigned projects

• 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 broad understanding of scientific research designs, worldwide regulatory requirements and commercial aspects of drug development

• Critically reviews regulatory submission documents for one or more major drug discovery or development projects

• 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 cross-functional teams to develop scientifically appropriate development strategies for assigned projects

• Represents 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 SSG functional area to ensure timely communication of project team updates, proper statistical strategies, and alignment of priorities between the project team and functional management

• Builds/drives inter-department relationships and teamwork

Training, Supervising, Mentoring:

• In conjunction with Director, and/or administrative management, coordinates and supervises statistical support for the assigned programs

• Effectively mentors other development stakeholders with regards to statistical methodology and departmental operations

• Manages personnel by appropriately delegating assignments, reviewing activities and defining and ensuring review of deliverables so that projects are completed on time with high quality

• Stimulates the scientific development of staff

• Develops and supervises departmental seminars, short courses, and the publication/presentation of scientific articles

• Works with Director and/or administrative management to develop and arrange appropriate training opportunities for staff and facilitate their timely career development

• Works with Director and/or appropriate administrative management to recruit qualified statisticians to the organization

• Ensures that staff 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 and self

Project Coordination / Regulatory Activities:

• Plans and coordinates statistical resources to best meet project area priorities

• Works with the Director and/or administrative management to ensure that projects incorporate sufficient statistical/scientific rigor and quality to meet stated objectives and global regulatory requirements

• Works with 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:

• For Director:
  
  • M.S./Ph.D. in Statistics, Biostatistics or a related field.
  • At least 6-10 yrs (PhD) or 12 -14 yrs (MS) experience in pharmaceutical development and applied statistics/statistical consulting with a minimum of 2 years of mentorship and/or management experience.
  • Advanced 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 exemplary statistical experience in managing and completing multiple projects or equivalent experience. Experience in leading NDA, BLA, and or CTD submission preferred. Experience interacting with regulatory agencies highly desirable.
  • Excellent communication skills, both oral and written.
  
  
  For Associate Director:
  
  
  • M.S./Ph.D. in Statistics, Biostatistics or a related field
  • At least 6-8 yrs (PhD) or 10-12 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