AbbVie Senior Manager, Statistics in Lake County, Illinois

Senior Manager, Statistics

USA, Illinois, Lake County

1 additional location

USA, Illinois

Research & Development

Requisition #1807293

Statistics is responsible for providing services in the area of biostatistics and mathematics to all corporate divisions. These services are supplied in the context of a cooperative, project-oriented effort and included statistical planning and scientific input in general planning and execution of clinical trials, pre-clinical trials and other experiments as well as integration of all scientific expertise and available technologies to provide statistical analysis of the data from these trials. These services also include the generation of scientific reports summarizing the trial or experimental results for communication to regulatory agencies and scientific audiences.

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) 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 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 Clinical and Regulatory to develop scientifically appropriate development strategies for assigned project

  • 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

Training, Supervising, Mentoring:

  • In conjunction with Associate Director and/or 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 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 / Biometrics 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 Director to build 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

Basic:

  • 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 pharmaceuticaldevelopment and applied statistics/statistical consulting required.

  • statistical modeling and inferential statistics; actively seeks to acquire knowledgeconcerning the use of new/novel statistical techniques and their biometric/ biopharmaceutical applications.

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

Manager, Statistics

Basic:

•MS or PhD in Statistics, Biostatistics, or a highly related field with a minimum of 3 years (PhD) experience.

•Must have comprehensive knowledge of applied statistical principles and modeling in drug research and development, and proficiency in statistical software such as SAS and R.

•Must have excellent interpersonal and effective verbal and written communication skills. Creates a learning environment, opens to suggestions and experimentation for improvement. Embraces the ideas of others, nurtures innovation and manages innovation to reality.

•Strong leadership skills and experience in managing a programming group.

Experience in working/managing in an international team.

•Builds strong relationships with peers and cross functionally with partners outside of team to enable higher performance. Raises the bar and is never satisfied with the status quo.

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

•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 preferred.

•Learns fast, grasps the 'essence' and can change the course quickly where indicated.

Equal Opportunity Employer Minorities/Women/Veterans/Disabled