Senior Statistical Programmer

eClinical Solutions helps life sciences organizations around the world accelerate clinical development initiatives with expert data services and the elluminate Clinical Data Cloud – the foundation of digital trials. Together, the elluminate platform and digital data services give clients self-service access to all their data from one centralized location plus advanced analytics that help them make smarter, faster business decisions. 

eClinical Solutions is committed to driving innovation in clinical trials through a better approach to data management and data analytics. We use the eClinical Solutions technology platform, elluminate, throughout the data management process to accelerate timelines for our clients and automate manual processes. We believe in a more agile approach to data management using our core technology elluminate - enabling our life sciences clients to proactively manage their clinical programs and make decisions. 

You will make an impact: 

Senior Statistical (SAS) Programmers work with Principal Technical Consultant to provide SAS programming in data extracted from various databases. Statistical Programmers document and program for the transformation of raw data to Study Data Tabulation Model (SDTM) datasets, Analysis Data Model (ADaM) datasets, and develop programming to produce Tables, Listings and Graphs/Figures (TLGs or TLFs). 

Accelerate your skills and career within a fast-growing company while impacting the future of healthcare. 

Your day to day: 

• 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  

Qualifications:  

• 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: