Senior Statistical Programmer

Role Overview

• Perform the role of Lead Statistical Programmer for assigned projects
• Continually seek ways and means to provide more efficient and effective programming practices
• Develop specifications for SDTM datasets and SDTM datasets specifications for Clinical Data Analysis (CDA configuration) module in elluminate
• Develop SAS programming to produce SDTM datasets and SDTM datasets for CDA configuration
• Develop specifications for Analysis Data Model (ADaM) datasets
• Develop SAS programming for ADaM datasets
• Responsible for developing and maintaining programming and validation specifications for TLGs as per requirements provided by the Biostatistician
• Create and maintain SAS programs to produce outputs to support the analysis and reporting of clinical trials
• Develop analysis datasets for trial level reporting and integrated safety and efficacy activities
• Program and QC data listings, summaries and Graphs as defined in SAP. If required, validate the statistical models used for programming
• Develop re-usable utility macros in order to build a macro library to support programming tables, listing and graphs for phase 1-4 clinical trial reporting
• Collaborate with the project team to ensure the deliverables are completed on time with high quality
• Create submission-ready standard data presentations and data sets using standard coding and following standard industry processes including SDLC
• Maintain all project documentation as required by SOP and Processes
• Mentor statistical programmers
• Ensure compliance with eClinical Solutions and industry quality standards, guidelines and procedures

Requirements

• Bachelor’s degree or equivalent work experience preferred
• 5+ years in Pharmaceutical/Biotechnology industry or equivalent IT consulting role preferred
• Strong experience in preparations for NDA filings
• Strong knowledge of ICH/GCP guidelines, 21 CFR Part 11 and clinical trial methodologies
• Knowledge of coding dictionaries (WHO, COSTART, ICD-9, MedDRA)
• Knowledge of CDISC® related data models like SDTM, and ADAM
• Experience of working on multiple clinical protocols at the same time
• Excellent verbal and written communication skills
• Detail oriented, ability to multitask with strong prioritization, planning and organization skills
• Excellent team player
• Experience of extracting, manipulating, merging, summarizing, analyzing and presenting data using SAS procedures
• Strong experience of base SAS programming, Proc SQL, macro programming, ODS and various SAS modules: SAS/GRAPH, SAS/STAT and other modules like SAS/Connect and SAS/Access is a must
• Experience with reporting environments and reporting tools related to SAS programming in pharmaceutical industry; proc report, proc summary and proc tabulate
• Strong experience in SAS programming in various phases of clinical trials
• Experience in pooled data analysis and programming
• Strong experience in efficacy reporting with regards to development of analysis sets and treating missing values
• Experience in working with relational databases and performance tuning of SAS programming
• Experience with writing batch scripts and/or shell scripts is a plus

Tech Stack

• Google Cloud Platform
• SDLC
• SQL

Benefits

• Health insurance
• 401(k) matching
• Flexible work hours
• Paid time off
• Remote work options