Cytel ยท 5 days ago
Principal Statistical Programmer FSP
United States
Full-time
Remote
Lead/Staff
8+ years expCytel is a company specializing in statistical programming for the pharmaceutical industry, and they are seeking a Principal Statistical Programmer FSP. This role involves providing technical leadership in SAS programming for clinical trial data analysis and ensuring compliance with regulatory standards.
ConsultingSoftware
Responsibilities
Provide technical leadership in SAS programs and applications designed to analyze and report complex clinical trial data in Tables, Listings, and Figures, and for electronic submissions of SDTM, ADaM datasets in CDlSC format, with minimal instruction or input from supervisor
Provide technical leadership to create, review, and approve documentation required to support data analysis, reporting, and CDlSC data submission
Ensure compliance with company SOP'S and FDA/ICH/GCP regulations
Perform quality control checks of advanced SAS code for datasets and output produced by other statistical programmers
Review, maintain study documents per standard process
Program, test, and document global utility programs and tools in accordance with standards and validation procedures
Conduct briefings and participate in technical meetings for internal and external representatives (e.g., IS, CROs, Clinical Development Partners, Software Vendors, FDA, EMA, et cetera) for projects
Perform lead duties when called upon
Perform other duties as assigned
Qualification
Required
Provide technical leadership in SAS programs and applications designed to analyze and report complex clinical trial data in Tables, Listings, and Figures, and for electronic submissions of SDTM, ADaM datasets in CDISC format, with minimal instruction or input from supervisor
Provide technical leadership to create, review, and approve documentation required to support data analysis, reporting, and CDISC data submission
Ensure compliance with company SOP'S and FDA/ICH/GCP regulations
Perform quality control checks of advanced SAS code for datasets and output produced by other statistical programmers
Review, maintain study documents per standard process
Program, test, and document global utility programs and tools in accordance with standards and validation procedures
Conduct briefings and participate in technical meetings for internal and external representatives (e.g., IS, CROs, Clinical Development Partners, Software Vendors, FDA, EMA, et cetera) for projects
Perform lead duties when called upon
Perform other duties as assigned
Proven expert in all SAS language, procedures, and options commonly used in clinical trial reporting including the Macro language, BASE SAS, SAS/STAT and SAS/GRAPH
Excellent and transparent communication skills and ability to interact across multiple functions
Adaptability and flexibility for when priorities change
Preferred
MS in biostatistics or a related field, with 8+ years of experience in pharmaceutical industry
BS in biostatistics or a related field, with 10+ years of experience in pharmaceutical industry
R programming experience is a plus
Company
Cytel
Our mission is to improve success rates in this endeavor via the optimal design, effective implementation
1001-5000 employees
H1B Sponsorship
Cytel 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 (38)
2024 (54)
2023 (37)
2022 (46)
2021 (43)
2020 (33)
Funding
Current Stage
Late StageTotal Funding
$2MKey Investors
New Mountain CapitalMerck Capital Ventures
2021-01-01Series Unknown
2020-12-21Acquired
2017-11-01Private Equity
Leadership Team
Cyrus Mehta
Co-Founder and President
Nitin Patel
Chairman and Chief Technology Officer
Recent News
Adial Pharmaceuticals, Inc
2025-08-14
2025-06-11
Company data provided by crunchbase