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Manager, Statistics - Biometrics

AbbVie

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Location:
Chicago, IL
Posted Date:
7/25/2014
Position Type:
Full time
Job Code:
140000033P
Salary:
Required Education:
Bachelors Degree
Areas of Expertise Desired:

Job Description

The Department of Biometrics has responsibility for Statistics of the clinical pharmacology aspects of drug development.  This comprises the statistical aspect of study designs and data analyses from Phase I studies, including pharmacokinetic and bioequivalence/bioavailability studies, pharmacodynamics, QT/QTc studies, and the earliest studies in humans.  In addition, the Department analyzes the pharmacokinetic and pharmacogenetic data from Phase II and Phase III studies and support exposure-response analyses.  We have an exciting opportunity for a Manager, Statistics - Biometrics or Senior Research Statistician - Biometrics based in North Chicago, IL reporting to the Associate Director, Biometrics.


 


Key Responsibilities:


 


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

 


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:


 


  • Extended understanding of statistical concepts and methodologies

  • Ability to apply statistical knowledge to solve real-world problems

  • 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 nsections 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

 


 


 


 


 


 


 


 

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Requirements

Position will be hired based on level of experience.


 


Basic:


 


For Manager Statistics (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

 


For Senior Research Statistician (Biometrics):


 


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

  • 0+ years (PhD) or at least 4-6 years (MS) of relevant experience required

  • High degree of technical competence and sound communication ability, both oral and written

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

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, opens to suggestions and experimentation for improvement

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

 


 


 


 


 


 


 


 


 

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