Sr. Statistical Programmer

Our client is focused on advancing first- or best-in-class medicines for childhood and adult diseases.

POSITION SUMMARY:

This position is fully remote with a requirement to work on Pacific Standard Time when requested.

ESSENTIAL DUTIES AND 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

QUALIFICATIONS:

• 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