Data Science Manager for Pharmaceutical Safety Analysis

3 weeks ago


South Chicago Heights, Illinois, United States Lifelancer Full time

Job Overview

We are seeking an experienced Data Science Manager to lead our pharmaceutical safety analysis team. The successful candidate will have a strong background in data science and a passion for delivering high-quality results in a fast-paced environment.

About the Role

The Data Science Manager will be responsible for leading the statistical programming activities for development and maintenance of integrated clinical safety data for multiple compounds and indications. This includes creating integrated safety data sets to support safety monitoring, signal detection, clinical safety analytics, and regulatory submissions.

Key Responsibilities

  • Lead a team of statistical programmers and manage resource planning for assigned staff.
  • Ensure timely deliverables and that all quality processes are followed consistently within projects.
  • Develop and oversee the development of SAS programs, product safety data integration plans, metadata, 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.
  • Create documentation for regulatory filings including reviewer guides and data definition documents.
  • Lead the development of data extraction and transformation automation tools, standard SAS Macros, and participate in the development of standard operating procedures and cross-functional process improvement initiatives.
  • Provide oversight and mentoring of assigned Statistical Programmers, Statistical Analysts, and Senior Statistical Analysts.
  • Work effectively with diverse groups of cross-functional team members within Data and Statistical Sciences and Patient Safety teams in resolving programming and data issues.

Requirements

  • Masters degree in Computer Science, Statistics, or related field with 8+ years of relevant experience OR Bachelor's degree in Computer Science, Statistics, or related field with 10+ years of relevant experience.
  • Previous experience leading a team of statistical programmers.
  • Experience in harmonizing clinical study data from multiple studies with diverse study designs, data standards spanning multiple indications (ideally in Oncology, Neuroscience, and Specialty therapeutic areas).
  • 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 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 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).
  • In-depth understanding of the drug development process, including experience with regulatory filings.

Salary and Benefits

The estimated salary for this role is $120,000 - $180,000 per year, depending on experience. We offer a comprehensive package of benefits, including paid time off, medical/dental/vision insurance, and 401(k) to eligible employees. This job is eligible to participate in our short-term incentive programs and long-term incentive programs.

Additional Information

AbbVie is an equal opportunity employer committed to operating with integrity, driving innovation, transforming lives, serving our community, and embracing diversity and inclusion. For more information about AbbVie, please visit our website at https://www.abbvie.com.



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