Katalyst Healthcares and Life Sciences
Senior Statistical Programmer
Katalyst Healthcares and Life Sciences, Cary, North Carolina, United States, 27518
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. ssist 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.
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. ssist 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.