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Senior Statistical Programmer

4 weeks ago

Cary NC, United States Katalyst CRO Full time

Overview Join to apply for the Senior Statistical Programmer role at Katalyst CRO . Learn more about the general tasks related to this opportunity below, as well as required skills. Note: This description outlines responsibilities and qualifications for the Senior Statistical Programmer position. 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 the same time and prioritize 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 (tidyverse, 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. Seniority level Mid-Senior level Employment type Contract Job function Information Technology Industries Pharmaceutical Manufacturing #J-18808-Ljbffr