eClinical Solutions · 2 months ago
Senior Statistical Programmer
United States
Full-time
Remote
Senior Level
5+ years expeClinical Solutions helps life sciences organizations accelerate clinical development initiatives with expert data services and the elluminate Clinical Data Cloud. The Senior Statistical Programmer will provide SAS programming expertise for data transformation, develop specifications for datasets, and produce outputs to support statistical analysis in clinical trials.
AnalyticsHealth CareInformation TechnologyPharmaceuticalProfessional ServicesSoftware
Responsibilities
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
Qualification
Required
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
Preferred
Experience with writing batch scripts and/or shell scripts is a plus
Company
eClinical Solutions
eClinical Solutions is a data intelligence hub.it transforms the way clinical data integration, aggregation, and analytics.
201-500 employees
H1B Sponsorship
eClinical Solutions has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (10)
2024 (7)
2023 (8)
2022 (5)
2021 (5)
Funding
Current Stage
Growth StageTotal Funding
unknownKey Investors
GI PartnersSummit Partners
2024-09-12Private Equity
2024-09-12Acquired
2020-01-21Private Equity
Leadership Team
Raj Indupuri
CEO
Sam Anwar
Chief Technology Officer
Recent News
Business Wire
2025-12-10
2025-10-13
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