Manager, Safety Statistical Programming

6 days ago

Boston, Massachusetts, United States AbbVie Full time

Company Description


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, Data Analytics, 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, metadata, ADaM specifications, ADaM data sets following CDISC standards and Tables, Listings and Figures (TLFs).
  • Responsible for harmonizing SDTM and nonstandard 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 crossfunctional process improvement initiatives.
  • Provides oversight and mentoring of assigned Statistical Programmers, Statistical Analysts and Senior Statistical Analysts.
  • Works effectively with diverse group of cross functional team members within Data and Statistical Sciences and Patient Safety teams in resolving programming and data issues.
  • 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.
  • Indepth understanding of SAS programming concepts and techniques related to drug development and demonstrated competency with handson experience in SAS programming, macro and utilities development.
  • Indepth 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 (ideally in Oncology, Neuroscience and Specialty therapeutic areas)
  • Experience in leading studies with handson 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.
  • Indepth 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

Additional Information

  • The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more or less than the posted range. This range may be modified in the future.
  • We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.
  • This job is eligible to participate in our shortterm incentive programs.
  • This job is eligible to participate in our longterm incentive programs

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, be

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