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Urgent! Senior Statistical Programmer Job Opening In Cary North Carolina – Now Hiring Katalyst Healthcares & Life Sciences

Senior Statistical Programmer



Job description

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 define.xml 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.


  • 7+ 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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