AbbVie Manager, Biometrics in Lake County, Illinois

Description:
AbbVie (NYSE:ABBV) is a global, research-based biopharmaceutical company formed in 2013 following separation from Abbott. AbbVie combines the focus and passion of a leading-edge biotech with the expertise and capabilities of a long-established pharmaceutical leader to develop and market advanced therapies that address some of the world’s most complex and serious diseases. In 2013, AbbVie will employ approximately 21,000 people worldwide and markets medicines in more than 170 countries.

Primary Job Function:

Provide statistical expertise for design, analysis and reporting of clinical or scientific research studies or programs

Core Job Responsibilities:

Responsible for compliance with applicable Corporate and Divisional Policies and procedures

Protocols:

Ensures consistency among protocols within a project, and provides certification for the protocol review check list Contributes to decision making on study design and data collection, ensuring alignment with study objectives Conducts comprehensive review of protocol to ensure quality Responsible for sample size estimation for routine and non-routine studies Independently determines appropriate statistical methodology needed in support of study objectives; develops and authors the statistical methods section of the protocol Responsible for randomization specifications for routine and non-routine studies Works effectively with external partners, including contract research organizations, drug supply, and other groups to effectively implement the randomization schedule as planned

Database Activities:

Actively participates in meetings to identify scientifically appropriate data collection instruments and database design requirements (e.g. SAS, MS Access, Excel) to ensure that the data evaluated are free of bias, contains maximum information (minimum variance), and satisfy analysis requirements

Statistical Analyses:

Demonstrates extended understanding of statistical concepts and methodologies Demonstrates ability to apply statistical knowledge to solve real-world problems Demonstrates ability to explain statistical concepts to non-statisticians to enhance their understanding of the analytical approach Develops analysis plans, ensuring statistical methods and corresponding details are appropriate and sound, consistent with the study design, and sufficiently detailed for programming implementation Ensures internal consistency of analysis plans for assigned studies/projects Analyzes data from clinical trials or scientific experiments to meet objectives of the study protocol Independently applies and implements basic and complex statistical methodology to analyses Independently identifies and anticipates technical or data related issues arising in the design, conduct or analysis of clinical trails or other scientific research Approves and implements alternative analysis strategies or other recommendations to address these issues Evaluates appropriateness of available software for planned analyses and ascertains needs for potential program development of novel statistical methodology

Scientific Reports and Publications:

Works with project team to develop strategy for data presentation and scientific/statistical arguments Ensures consistency of data presentations among reports within a project with supervision Develops statistical methods and other relevant sections of major deliverables such as protocols, analysis plans, study reports and scientific publications with supervision. Identifies and implements corrections to flaws in scientific logic and statistical interpretation Prepares oral and written reports that effectively communicate results of scientific research to the project team, AbbVie management, regulatory agencies, or individual investigators Ensure consistency in presentation, inference, and adherence to accepted report guidelines and publication practices Ensures internal consistency of statistical methods sections of reports for routine and non-routine situations, and ensures alignment with analyses as conducted Collaborates in publication of scientific research results in assigned areas Ensures accuracy and internal consistency of report or publication, including text, tables, listings, and figures Ensures as applicable that guidance and template format for protocol, analysis plan and study report are closely followed Performs peer review for protocol, analysis plan, study report, and other major deliverables, publications Provides critical review to enhance quality of data presentation and scientific/statistical arguments Responsible for providing critical review to enhance quality and accuracy of data presentation and scientific/statistical arguments

Consultation:

Works collaboratively with members of multi-function teams to complete project deliverables per agreed timelines Keeps management informed on important scientific/statistical issues that may arise, in a timely manner Provides responses to routine and non-routine questions from clients, and independently pursues analyses suggested by the data In collaboration with Statistical Programming or their designee, ensures that all programs meet analysis requirements, internal standard operating procedures, validation, and external regulatory requirements Communicates with statisticians outside AbbVie concerning technical issues, building external scientific contacts, fostering professional development, and promoting the reputation of the department Responsible for developing and maintaining good client relationships Effectively and persuasively presents statistical concepts, evidence, assessment of risks and impacts, and logical arguments to other statisticians, scientists and other personnel Communicates a basic understanding of scientific and regulatory principles for assigned projects

Training, Supervising, Mentoring:

Maintains technical skills and increases own knowledge of new statistical methodology or areas of application through use of the scientific literature and attendance at professional meetings Presents own statistical research or review of the statistical literature at meetings and seminars Demonstrates a high degree of responsibility in maintaining Statistics/Biometrics department standards, GxP compliance, and best operating practices Participates in departmental activities including recruiting , training/mentoring, research efforts and cross-functional collaborations, as needed

Regulatory Activities:

Participates with DSS or Biometrics management in discussions with corresponding technical personnel from regulatory agencies and with investigators concerning proposed or ongoing studies Position Accountability / Scope:

Accountable for providing statistical expertise for design, analysis, and reporting of clinical trials or other scientific research

Qualifications:
Minimum Education and Experience Required


For Manager, Biometrics:

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 preferred Identifies data or analytical issues and either applies skills and knowledge to solve problems or seeks help to achieve solutions.

Job Classification: Experienced
Job: RESEARCH AND DEVELOPMENT
Primary Location: USA-Illinois-Lake County
Organization: Research & Development
Schedule: Full-time
Shift: Day
Travel: Yes, 5 % of the Time
Req ID: 1704450

Equal Opportunity Employer Minorities/Women/Veterans/Disabled