princeps technologies · 1 day ago
Senior Statistical Programmer
United States
Full-time
Remote
Senior LevelPrinceps Technologies is seeking an experienced Senior Statistical Programmer to support end-to-end clinical programming activities across multiple studies. The role requires strong technical proficiency and the ability to collaborate effectively within cross-functional and global teams while leading statistical programming deliverables.
Computer Software
Hiring Manager
Aishwarya Purushotham
Responsibilities
Program, validate, and maintain clinical trial datasets and outputs using SAS and R
Lead and execute the full spectrum of statistical programming deliverables, including:
Creation and review of SDTM and ADaM specifications
Development of SDTM and ADaM datasets
TLF (Tables, Listings, Figures) programming
Preparation of Define.xml and reviewer’s guides
Develop, enhance, and maintain macros to support study and project requirements
Work independently with minimal oversight, ensuring timely and high-quality deliverables
Demonstrate a strong sense of ownership and accountability for assigned tasks
Communicate proactively with internal teams, providing clear updates and technical guidance
Identify opportunities for process improvements and contribute suggestions to strengthen team efficiency
Proven experience working on oncology clinical trials, with a strong understanding of oncology-specific endpoints and data structures
Participate actively in programming meetings, cross-functional discussions, and knowledge-sharing sessions
Qualification
Required
Program, validate, and maintain clinical trial datasets and outputs using SAS and R
Lead and execute the full spectrum of statistical programming deliverables, including: Creation and review of SDTM and ADaM specifications
Development of SDTM and ADaM datasets
TLF (Tables, Listings, Figures) programming
Preparation of Define.xml and reviewer's guides
Develop, enhance, and maintain macros to support study and project requirements
Work independently with minimal oversight, ensuring timely and high-quality deliverables
Demonstrate a strong sense of ownership and accountability for assigned tasks
Communicate proactively with internal teams, providing clear updates and technical guidance
Identify opportunities for process improvements and contribute suggestions to strengthen team efficiency
Proven experience working on oncology clinical trials, with a strong understanding of oncology-specific endpoints and data structures
Participate actively in programming meetings, cross-functional discussions, and knowledge-sharing sessions
Preferred
Prior experience working in global or geographically distributed teams
In-depth knowledge of CDISC standards and regulatory submission requirements
Experience supporting FDA and PMDA submissions
Ability to manage multiple studies simultaneously and prioritize tasks effectively
Strong documentation, planning, and organizational skills
Experience mentoring or providing technical oversight to junior programmers
Company
princeps technologies
Princeps Technologies partners with life sciences organizations to build, scale, and integrate the strategic capabilities that accelerate innovation — from program to patient.
11-50 employees
H1B Sponsorship
princeps technologies 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
2024 (2)
2023 (1)
Funding
Current Stage
Early StageCompany data provided by crunchbase