Cytel · 1 day ago
Principal Statistical Programmer FSP
United States
Full-time
Remote
Senior Level, Lead/Staff
7+ years expCytel is a company dedicated to advancing patient treatment through innovative clinical development programs. The Principal Statistical Programmer will work independently within a pharmaceutical client, providing expert technical support and overseeing CRO programmers to ensure high-quality data summaries for clinical trials.
ConsultingSoftware
Responsibilities
Generate SDTM, ADaM specifications, datasets, reviewer’s guide and define.xml files for multiple studies
Develop SAS programs which generate datasets, complex listings, tables (including those with descriptive and standard inferential statistics in collaboration with a Statistician), and complex graphs
Deliver high-quality statistical programming results including developing, validating, and maintaining SAS and/or R programs tailored to clinical development programs’ needs
Participate in overseeing CRO’s statistical programming deliverables for multiple clinical studies to ensure high-quality and meet the pre-specified timelines
Support the preparation of clinical study reports, regulatory submissions, publications, annual DSUR, and exploratory analyses
Understand and follow FDA regulations which affect the reporting of clinical trial data. This includes good clinical practice and guidelines for electronic submissions
Contribute to the creation, maintenance, documentation, and validation of standards for programming tools, outputs, and macros
Participate in the development of CRFs, edit check specifications, and data validation plans
Provide review and/or author data transfer specifications for external vendor data
Collaborate with internal and external functions (e.g. CROs, software vendors, clinical development partners, etc.) to ensure meeting project timelines and goals
Provide review and/or author SOPs and/or Work Instructions related to statistical programming practices
Qualification
Required
At a minimum bachelor's degree in computer science, data science, mathematics, or statistics major preferred
7+ years of experience as a Statistical Programmer on a Biotech/Pharma Clinical Development Biometrics Team or with a similar team and experience supporting drug development, medical device development, or intervention studies
Exceptional SAS programming skills and expertise in the development and implementation of statistical programming procedures and processes in a clinical development environment
Extensive applied experience of CDISC standards (SDTM, ADaM, and Define.xml), medical terminology, clinical trial methodologies, and FDA/ICH regulation
Experience supporting regulatory submissions, interacting with the FDA and/or global regulatory authorities
Must be able to work independently
Outstanding communication skills (written and verbal) and strong leadership skills
Preferred
Prior work experience with pharmacokinetic data and the neuroscience field
proficiency in languages or tools other than SAS (e.g., R, Python, and Java, Shiny, Markdown, Unix/Linux and git)
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
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2025-08-14
2025-06-11
Company data provided by crunchbase