Associate Director, Statistics
Company: Allergan
Location: Irvine
Posted on: January 22, 2023
Job Description:
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. Associate Director,
Statistics Primary Irvine, California Req ID 2215425 Category
Research and Development Division AbbVie
- Protocols: Direct development of statistical designs and
analysis procedures for scientific protocols, ensuring they are
scientifically sound, aligned with project strategy, meet
regulatory objectives and make optimal use of the data to be
collected. Ensure statistical analysis plan is methodologically
sound and consistent with objectives of the protocol. Assist in
developing project and functional standards of data collection and
analysis, and implement these standards.
- Database Activities: Collaborate with Data Sciences,
Statistical Programming and other stakeholders to ensure data
collection instruments and database implementation meets short and
long-term project needs. Contribute to data monitoring plans.
Develop and implement project-specific data standards. Ensure
accuracy and consistency of data released for statistical
analysis.
- Statistical Analyses: Demonstrate extensive understanding of
statistical concepts and methodology. Propose novel statistical
methodological approaches leading to improvement in the efficiency
and sensitivity of study results. Provide sufficient detail to
allow programming implementation. Ensure that all statistical
analyses specified in scientific protocols and analysis plans are
conducted appropriately. Determine need for development of novel
statistical methodology.
- Reports and Publications: Ensure that study results and
conclusions are scientifically sound, clearly presented, and
supported by statistical analyses. Prepare oral and written reports
to communicate results. Represent Data and Statistical Sciences on
project issues at management review and project team meetings.
Provide in-depth statistical review for scientific reports and
publications. Ensure the accuracy of the statistical component of
scientific reports and publications with high quality.
- External Engagement: Act as the liaison for statistical and
operational issues on AbbVie collaborative studies with outside
universities, government agencies, steering and/or data monitoring
committees, joint ventures, CROs or licensing activities. Build
external scientific contacts which foster professional development
and promote the reputation of the department. Work with Director to
build relationships between DSS and outside investigators and
medical/scientific experts.
- Project Team Involvement: Partner with Clinical and Regulatory
to create development strategies for assigned project. Represent
department on project team(s) to provide statistical input to
compound/drug development and align with functional management.
Lead communication between assigned project team(s) and department
to ensure timely communication of project team updates, proper
statistical strategies, and alignment of decisions/priorities
between the project team and functional management
- Regulatory Activities: Ensure that all applicable regulatory
requirements for work processes are met. Critically review
regulatory submission documents. Participate in discussions with
regulatory agencies as needed. Validate external statistical
software to meet SOPs and regulatory requirements.
- Compliance: Compliant with applicable corporate and divisional
policies, procedures and cultural values. Maintain up-to-date
knowledge of Standard Operating Procedures and working practices
relevant to managers and the Statistics function. Ensure compliance
with department standards, GxP and best operating practices for
staff and self. Complete all assigned training on
time.Qualifications
- MS (with a minimum of 10 years of experience) or PhD (with a
minimum of 6 years of experience) in Statistics, Biostatistics, or
a highly related field.
- Broad knowledge of, and compentence in, statistical methodology
(including experimental design, descriptive statistics, inferential
statistics, statistical modeling, and statistical programming) and
experience in applied statistics/statistical consulting.
- At least 10 years (MS) or 6 years (PhD) of experience in
pharmaceutical development. Understanding of global regulatory
requirements. Experience interacting with regulatory agencies
highly desirable.
- Management experience highly desirable for people
managers.
- Expertise in statistical methodologies such as predictive
modeling and inference, machine learning methods, mixed effects
models, multivariate analysis, etc.Applicable to California
Applicants Only - The below range is the range that we in good
faith believe is the range of possible compensation for this role
at the time of this posting. We may ultimately pay more or less
than the posted range and this range is only applicable for jobs to
be performed in California.This range may be modified in the
future. - The salary range is (minimum: $ 126,500 to maximum: $
247,000 ) - This job is eligible to participate in our short-term
incentive program - This job is eligible to participate in our
long-term incentive programs - We offer comprehensive package of
benefits including paid time off (vacation, holidays, sick),
medical/dental/vision insurance and 401(k) to eligible employees.
- Note: No amount of pay is considered to be wages or
compensation until such amount is earned, vested, and determinable.
The amount and availability of any bonus, commission, incentive,
benefits, or any other form of compensation and benefits that are
allocable to a particular employee remains in the Company's sole
discretion unless and until paid and may be modified at the
Company's sole discretion, consistent with the law.At AbbVie, we
value bringing together individuals from diverse backgrounds to
develop new and innovative solutions for patients. As an equal
opportunity and affirmative action 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. If you would like to
view a copy of the company's affirmative action plan or policy
statement, please email CorpJat_ABV@abbvie.com . Significant Work
Activities: Continuous sitting for prolonged periods (more than 2
consecutive hours in an 8 hour day) Explore our open jobs and find
your perfect fit.Join our talent network and receive AbbVie news
and job alerts to your inbox. First name Last name Phone number
Email address Interested In Please select a category or location
option. Click "Add" to create your job alert. Category Location
- Research and Development, Irvine, California, United States
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Keywords: Allergan, Irvine , Associate Director, Statistics, Executive , Irvine, California
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