Responsibilities:

• Validate and create SDTM, ADaM, and Tables, Figures, and Listings (TFLs), including associated documentation like define.xml using SAS.
• Write or review data specifications for Study Data Tabulation Model (SDTM) and Analysis Data Model (ADaM).
• 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.
• 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.
• 8+ 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.

• Validate and create SDTM, ADaM, and Tables, Figures, and Listings (TFLs), including associated documentation like define.xml using SAS.
• Write or review data specifications for Study Data Tabulation Model (SDTM) and Analysis Data Model (ADaM).
• 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.
• 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