AbbVie Associate Director, Safety Statistics in Lake County, Illinois
The Safety Statistics Group (SSG) at AbbVie is a leader and driver of the Safety and Statistics Excellence Program (SSEP) and Benefit-Risk (B/R) assessment. This group is an important strategic and tactical part of Data and Statistical Sciences (DSS) that works as part of a collaborative, cross functional partnership in drug safety and benefit-risk assessment.
The SSG focuses specifically on partnering with Pharmacovigilance and Patient Safety (PPS) in evaluation, interpretation, and reporting of safety data analyses. The work involves all stages of development and life cycle management in the AbbVie portfolio (including proactive aggregate/integrated safety and benefit risk analyses planning, execution, and interpretation).
AbbVie is seeking an experienced statistician with strategic skills to serve in a leadership role in our growing Safety Statistics team. The Associate Director, Safety Statistics will have people management responsibility and be responsible for one or several Product Safety Teams (PSTs) in one of AbbVie’s primary therapy areas and for developing one or more best practices in safety and benefit-risk technical expertise (eg, meta-analysis, Bayesian methods) and tool development (e.g., JReview).
Key Responsibilities Include:
- Responsible for compliance with applicable corporate and divisional policies and procedures.
- Responsible for resource management within SSG for assigned projects.
- As a leader in SSG, identify and implement best practice processes and safety analytic and graphic methods in collaboration with SSG colleagues across AbbVie therapeutic areas.
- Primary author of the Product Safety Statistical Analysis Plan and Integrated Summary of Safety Statistical Analysis Plan. Assure alignment across the PSSAP, the PSP, individual study SAPs, and the ISS SAP, and timely distribution of quality ISS, PSUR/PBRER, DSUR, IB, and RMP outputs.
- Active participant in Benefit-Risk value tree creation/discussion and responsible for the appropriate BR analyses (Benefit Risk Product Assessment and relevant submission documents).
- For assigned projects, provide specifications on how the data should be integrated across studies in accordance with the PSSAP provided to statistical programming and ensure appropriate analyses and interpretation for PBRER/DSUR/IB/RMP/Regulatory Requests, signal evaluations and Safety Summary for NDA/BLA/Other Regulatory Activities.
- Understand and support the use of safety graphics for ongoing safety review (JReview and other relevant tools) and appropriate inclusion in safety submission documents noted above.
- Represent SSG in strategic initiatives that address processes relating to interpreting, monitoring, assessing, and reporting safety data.
Represent SSG/DSS on initiatives driven by external professional organizations such as ASA, PhUSE, DIA, etc.
- MS/PhD in Statistics, Biostatistics or related field. Minimum 6 years of experience (PhD) or 12 years (MS) is required.
- 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.
- Substantive interactions with regulatory authorities preferred.
- 3 years of experience in leading a diverse group of statistical scientists, and oversight of safety-oriented projects.
- Demonstrated highly effective written and verbal communication skills and demonstrated ability to navigate, negotiate and influence benefit-risk and safety monitoring/integration.
- Awareness of key challenges in the rapidly evolving drug safety and benefit-risk environment.
Proven ability to understand and implement relevant benefit-risk and/or safety monitoring methods and visualizations.
Key Leadership Competencies:
Builds strong relationships with peers and cross functionality with partners outside of team to enable higher performance.
- Learns fast, grasps the ‘essence’ and can change course quickly where indicated.
- Raises the bar and is never satisfied with the status quo.
- Creates a learning environment, open to suggestions and experimentation for improvement.
- Embraces the ideas of others, nurtures and manages innovation to reality.
Job Classification: Experienced
Job: RESEARCH AND DEVELOPMENT
Primary Location: USA-Illinois-Lake County
Organization: Research & Development
Travel: Yes, 5 % of the Time
Req ID: 1607112
Equal Opportunity Employer Minorities/Women/Veterans/Disabled