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Senior Statistical Programmer

Senior Statistical Programmer

Katalyst HealthCares & Life SciencesCary, NC
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Responsibilities :

  • Hands-on statistical programming to support CSR, publications, presentations, DSUR, IB update, safety data review, reconciliation, ad hoc analyses, patient profiles, and monthly safety reports in a fast-paced environment.
  • Write or review data specifications for Study Data Tabulation Model (SDTM) and Analysis Data Model (ADaM).
  • Validate and create SDTM, ADaM, and Tables, Figures, and Listings (TFLs), including associated documentation like using SAS.
  • Ensure that all programming and data are conducted in compliance with GCP, relevant SOPs, and regulatory requirements.
  • Assist in the development of template programs or macros and standard specifications to improve efficiency in the Statistical Programming group.
  • Work on multiple tasks at same time and prioritizes tasks to meet timelines on a regular basis.
  • Collaborates with Biostatisticians, Clinical Data Management, and Clinical Research Scientists on studies when needed.
  • Support RWE data curation and summaries in coordination with Biostatistics.
  • May assist with testing R and relevant R packages to either validate or develop R-based code solutions.

Requirements :

  • Bachelor's or higher degree in Statistics, Math or Computer Science or other suitable qualification related to the field.
  • years of statistical programming experience in the pharmaceutical industry.

    • Strong SAS programming and statistical background along with experience with Base SAS, SAS Macros, SAS / STAT, SAS / Graph, SAS / SQL, SAS / ODS.

  • Basic level of R knowledge or experience using R and relevant R packages (tidy verse, admiral, etc.) is preferred.
  • Thorough understanding of clinical trial design as well as regulatory reporting requirements including electronic data submissions and CDISC implementation
  • Experience working with oncology trials, PK analysis, and NDA or BLA submissions.
  • Excellent verbal and written communication skills and interpersonal skills are required.
  • Strong hands-on programming skills to deliver results in a fast-moving environment with the ability to work independently when only given loosely defined specifications.
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    Senior Programmer • Cary, NC