Company: AbbVie, Inc.
Posted on: April 5, 2021
Job Description About AbbVie
AbbVie's mission is to discover and deliver innovative medicines
that solve serious health issues today and address the medical
challenges of tomorrow. We strive to have a remarkable impact on
people's lives across several key therapeutic areas: immunology,
oncology, neuroscience, eye care, virology, women's health and
gastroenterology, in addition to products and services across its
Allergan Aesthetics portfolio. For more information about AbbVie,
please visit us at www.abbvie.com . Follow @abbvie on Twitter ,
Facebook , Instagram , YouTube and LinkedIn .
This role will provide statistical support for development strategy
for clinical or scientific research programs.--
- Ensures consistency among protocols within a project, and
provides certification for the protocol review check list. Works
project team to select an appropriate study design to meet study
objectives, contributes to decisions regarding data collection
instruments. Conducts comprehensive review of protocol to ensure
quality. Responsible for conducting research and identifying key
sample size estimation.
- Independently determine appropriate statistical methodology
needed in support of study objectives; develops and
authors the statistical methods section of the protocol.
Responsible for randomization for routine and non-routine studies.
external partners, including contract research organizations, drug
supply, and other groups, to effectively implement the
schedule as planned.
- 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, contain maximum information (minimum
variance), and satisfy analysis requirements.
- Demonstrates extended understanding of statistical concepts and
methodologies. Demonstrates ability to apply statistical knowledge
to solve real-world problems. Demonstrates the ability to evaluate
alternative statistical approaches, to make recommendations based
on sound statistical reasoning, and to influence non-statisticians
to accept the analytical approach.
- Reviews identified or anticipated technical or data related
issues arising in the design, conduct or analysis of clinical
trials 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.
- Works with project team to develop strategy for data
presentation and scientific arguments. Ensures consistency of data
presentations and scientific/statistical arguments among reports
within a project. Responsible for statistical methods and relevant
sections for major deliverables such as protocols, analysis plans,
study reports and scientific publications. Responsible for accurate
interpretation of analysis results. Responsible for high quality
- Prepares oral and written reports that effectively communicate
results of scientific research to the project team, AbbVie
management, regulatory agencies, or individual investigators.
Responsible for consistency between deliverables for the same
compound and/or within same therapeutic area. Responsible for
accuracy and internal consistency of report of publication,
including text, tables, listings, and figures. Ensures as
applicable that guidance and template format for protocol &
- 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
non-routine questions from clients, and independently pursues
analyses suggested by the data.
- Represents Data and Statistical Sciences (DSS) or Biometrics on
assigned project team(s) to provide functional area input to
compound/drug development. Serves as a liaison between the project
team and DSS or Biometrics to ensure timely communication of
project team updates, proper statistical strategies, and alignment
of priorities between the project team and functional area.
- 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.
- MS or PhD in Statistics, Biostatistics or a highly related
- At least 4-6 years (PhD) or 8-10 years (MS) of experience in
development and applied statistics/statistical consulting
- 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 a regulated environment preferred.
Significant Work Activities
Yes, 5 % of the Time
Job Level Code
Equal Employment Opportunity
At AbbVie, we value bringing together individuals from diverse
backgrounds to develop new and innovative solutions for patients.
As an equal opportunity employer we do not discriminate on the
basis of race, color, religion, national origin, age, sex
(including pregnancy), physical or mental disability, medical
condition, genetic information gender identity or expression,
sexual orientation, marital status, protected veteran status, or
any other legally protected characteristic.
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Keywords: AbbVie, Inc., Santa Rosa , Senior Manager, Executive , Clearlake, California
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