eClinical Solutions · 11 hours ago
Manager of Statistical Programming
United States
Full-time
Remote
Senior Level, Lead/Staff
$136K/yr - $170K/yr
8+ years expeClinical Solutions is a company that helps life sciences organizations accelerate clinical development initiatives through expert data services and the elluminate Clinical Data Cloud. The Manager of Statistical Programming is responsible for overseeing the statistical programming team, providing project leadership and programming support for clinical studies, and ensuring high-quality deliverables in compliance with industry standards.
AnalyticsHealth CareInformation TechnologyPharmaceuticalProfessional ServicesSoftware
Responsibilities
Determine resourcing needs per project load, deadline requirements and resource utilization
Create or review and approve programming plans at study and project level
Provide input on key study-related documents produced by other functions (e.g. CRFs, Data Management Plans, SAPs, etc.)
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
Assist Biostatisticians by suggesting algorithms to address novel analysis requests
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
Develop re-usable utility macros to build a macro library to support programming tables, listing and graphs for all phases of clinical trial reporting
Create submission-ready SDTM and ADaM datasets following standard industry processes
Performs peer review of all SAS Programmers’ deliverables
Serve as Subject Matter Expert for Statistical deliverables and lead task forces to develop complex, technical solutions for projects or business needs
Collaborate with the project team and other Professional Services Managers to ensure the deliverables are completed on time with high quality
Develops and maintains good working relationships with internal cross functional teams and Clients
Develops, revises, and maintains Standard Operating Procedures and Work Instructions. Assists in the training of Standard Operating Procedures and Work Instructions
Maintain all project documentation as required by SOP and Processes
Ensure compliance with eClinical Solutions and industry quality standards, guidelines and procedures
Champion the evolution of statistical programming through automation and advanced analytics using elluminate®
Lead internal initiatives focused on standards governance, coding conventions, validation frameworks, and reusable assets
May serve as Lead Statistical Programmer on projects when needed
Other duties as assigned
Qualification
Required
Excellent knowledge of English
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
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 trial
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
Bachelor's or Master's degree in Statistics, Computer Science, Mathematics, Engineering, Life Sciences, or a related field and/or equivalent work experience
8+ years' experience in Pharmaceutical/Biotechnology industry or equivalent IT consulting role
2+ years of leadership, supervisory, or technical lead experience
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
Company data provided by crunchbase