MMS · 2 days ago
Senior Statistical Programmer - Remote (US)
United States
Full-time
Remote
Senior Level
5+ years expMMS is an award-winning, data-focused clinical research organization (CRO) that supports the pharmaceutical, biotech, and medical device industries. They are seeking a Senior Statistical Programmer who will be responsible for generating tables, listings, and graphs from clinical trial databases using SAS and leading programming project teams.
BiotechnologyHealth CareLife Science
Responsibilities
Mastery and trained on generating tables, listings, and graphs from clinical trial databases using SAS
Utilizes System Development Life Cycle (SDLC) for programming deliverables
Advanced user in SAS programming, SAS Base, and SAS Macros
Advanced knowledge of E-Submission Standards, Guidelines and Regulations
Mastery and trained on SDTM standards including ability to write specifications
Advanced knowledge of ADaM standards including supporting specification writing
Proficient with MS Office applications
Advanced knowledge of ICH, 21CRF Part 11, and ISO 9001:2000 requirements
Advanced experience with pooling of data sets for submissions
Advanced experience with BIMO outputs, define.xml, Reviewer's Guides, SDSP
Lead study or small programming project teams
Qualification
Required
Mastery and trained on generating tables, listings, and graphs from clinical trial databases using SAS
Utilizes System Development Life Cycle (SDLC) for programming deliverables
Advanced user in SAS programming, SAS Base, and SAS Macros
Advanced knowledge of E-Submission Standards, Guidelines and Regulations
Mastery and trained on SDTM standards including ability to write specifications
Advanced knowledge of ADaM standards including supporting specification writing
Proficient with MS Office applications
Advanced knowledge of ICH, 21CRF Part 11, and ISO 9001:2000 requirements
Advanced experience with pooling of data sets for submissions
Advanced experience with BIMO outputs, define.xml, Reviewer's Guides, SDSP
Lead study or small programming project teams
Masters required for all Statistics roles
Minimum of 5 years' experience in Statistical Programming or similar field required
Expert knowledge of scientific principles and concepts
Reputation as emerging leader in field with sustained performance and accomplishment
Proficiency with MS Office applications
Good communication skills and willingness to work with others to clearly understand needs and solve problems
Excellent problem-solving skills
Good organizational and communication skills
Preferred
Hands-on experience with clinical trial and pharmaceutical development preferred
Familiarity with current ISO 9001 and ISO 27001 standards preferred
Familiarity with 21 CFR Part 11, FDA, and GCP requirements
Basic understanding of CROs and scientific & clinical data/terminology, & the drug development process
Company
MMS
MMS Holdings (MMS) is an award-winning, data-focused clinical research organization (CRO) that supports the pharmaceutical and biotech industries with a proven, scientific approach to complex trial data and regulatory submission challenges.
501-1000 employees
H1B Sponsorship
MMS 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 (2)
2024 (2)
2023 (2)
2022 (8)
2021 (9)
2020 (5)
Funding
Current Stage
Late StageTotal Funding
unknownKey Investors
Lindsay Goldberg
2022-06-28Private Equity
Leadership Team
Christopher Schoonmaker
Chief Operating Officer
Kevin Chartier
Principal Advisor, Biostatistics and Submission Planning
Recent News
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