Senior Manager/Manager Safety Statistics

Employer
AbbVie
Location
Lake County, IL, US
Posted
Oct 05, 2018
Ref
1807284
Required Education
Masters Degree/MBA
Position Type
Full time
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 physicia, 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 Senior Manager or Manager, Safety Statistics, depending on experience, based in North Chicago, IL reporting to the Director, Safety Statistics.

Key Responsibilities:

Authors the Product Safety Statistical Analysis Plans (PSSAPs) and Integrated Summary of Safety Statistical Analysis Plans (ISS SAPs); leads the development of safety data integration specifications; leads the development, delivery, and interpretation of safety-related outputs to address pre-planned and ad hoc safety analyses; collaborates with cross-functional team on benefit-risk planning and assessment, including leading the development of quantitative benefit-risk methods.

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

• 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 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 Associate Director and/or Director, coordinates statistical support for assigned projects

• 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 Associate Director and/or Director to arrange training opportunities for staff to facilitate their timely career development

• Works with 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 Associate Director and/or 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

Position will be hired based on level of experience

Basic:

For Senior Manager, Statistics:

• MS or PhD in Statistics, Biostatistics or a highly related field

• At least 4-6 years (PhD) or 8-10 years (MS) of experience in pharmaceutical development and applied statistics/statistical consulting required

• High degree of technical competence and effective oral and written communication skills

• Competent in experimental design, statistical modeling and inferential statistics; actively seeks to acquire knowledge concerning the use of new/novel statistical techniques and their biometric/ biopharmaceutical applications

• Pharmaceutical or related industry experience with nonclinical, clinical or pharmacology studies, as appropriate, including experience and understanding of drug development in the regulated environment preferred

• Works collaboratively with function management and multiple stakeholders to develop strategies for addressing issues/requirements that arise in clinical, nonclinical or pharmacology programs, as appropriate

For Manager, Statistics:

• MS or PhD in Statistics, Biostatistics or a highly related field

• At least 2-4 years (PhD) or 6-8 years (MS) of experience in pharmaceutical development and applied statistics/statistical consulting required

• High degree of technical competence and effective oral and written communication skills

• Competent in experimental design, descriptive and inferential statistics, biometrics/biopharmaceutical applications and computer programming

• Pharmaceutical or related industry experience with nonclinical, clinical or pharmacology studies, as appropriate, including experience and understanding of drug development in the regulated environment is preferred

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, open to suggestions and experimentation for improvement

• Embraces the ideas of others, nurtures innovation and manages innovation to reality

Equal Opportunity Employer Minorities/Women/Veterans/Disabled