Skip to main content

This job has expired

You will need to login before you can apply for a job.

Manager, Statistical Programming (Safety)

Employer
AbbVie
Location
Lake County, Illinois
Start date
Jan 26, 2024

Job Details

The Manager of Safety Statistical Programming is a strategic role in the emerging field of safety science providing programming expertise for development of pooled safety data sets and providing technical guidance to team of Statistical Programmers in the research, development, and safety assessment of pharmaceutical products.  This role is directly responsible for leading the statistical programming activities for development and maintenance of integrated clinical safety data for multiple compounds and indications.  The Manager of Safety Statistical Programming must effectively interface with team members from Statistics, Data Sciences, Pharmacovigilance and Patient Safety, Clinical Data Strategy & Operations, Medical Writing, Regulatory Publishing and Clinical Operations.

Responsibilities:

  • Leads the statistical programming activities for three or more compounds in creating integrated safety data sets to support safety monitoring, signal detection, clinical safety analytics and regulatory submissions.
  • Leads a team of statistical programmers and manages the resource planning for assigned staff.
  • Ensures timely deliverables, that all quality processes are followed consistently within the projects.
  • Develops and oversees the development of SAS programs, Product safety data integration plan, ADaM specifications, ADaM data sets following CDISC standards and Tables, Listings and Figures (TLFs).
  • Responsible for harmonizing SDTM and non-standard source data across multiple studies, creation, and validation of ADaM and TLFs for all safety deliverables following AbbVie’s SOPs, department, and project standards.
  • Demonstrated satisfactory ability to interpret statistical analysis plans to develop analysis data set specifications.
  • Creates documentation for regulatory filings including reviewers guides and data definition documents.
  • Leads the development of data extraction and transformation automation tools, standard SAS Macros and participates in the development of standard operating procedures and cross-functional process improvement initiatives.
  • Works effectively with diverse group of cross functional team members within Data and Statistical Sciences and Patient Safety teams.
  • Be compliant with training requirements.

Qualifications:

  • MS in Computer Science, Statistics, or a related field with 8+ years of relevant experience. OR BS in Computer Science, Statistics, or a related field with 10+ years of relevant experience.
  • Previous experience leading a team of statistical programmers.
  • In-depth understanding of SAS programming concepts and techniques related to drug development and demonstrated competency with hands-on experience in SAS programming, macro, and utilities development.
  • In-depth understanding of CDISC Standards (SDTM and ADaM).
  • Experience in leading statistical programming activities supporting IB, DSUR, PSUR, Integrated Summary of Safety (ISS), Annual Safety Reports and/or other safety analysis.
  • Experience in harmonizing clinical study data from multiple studies with diverse study designs, data standards spanning multiple indications.
  • Experience in leading studies with hands-on experience for developing ADaM specs, SAS Programs and TLFs.
  • Experience in SAS Programming on LINUX, LINUX shell scripting, developing data transformation automation tools and experience in programming languages such as R, Python is preferable.
  • In-depth understanding of the drug development process, including experience with regulatory filings.
  • Strong technical and communication skills, both oral and written.
  • Ability to effectively represent the Statistical Programming Organization in cross functional teams.
  • Ability to accurately estimate effort required for project related programming activities.

AbbVie is committed to operating with integrity, driving innovation, transforming lives, serving our community, and embracing diversity and inclusion. It is AbbVie’s policy to employ qualified persons of the greatest ability without discrimination against any employee or applicant for employment because 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, status as a protected veteran, or any other legally protected group status.


Company

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, and YouTube.

Stock Symbol: ABBV

Stock Exchange: NYSE

Company info
Website
Phone
1-800-255-5162
Location
1 North Waukegan Road
North Chicago
Illinois
60064
US

Get job alerts

Create a job alert and receive personalized job recommendations straight to your inbox.

Create alert