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Senior Statistical Programmer - Remote (US) jobs in United States
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MMS · 1 month ago

Senior Statistical Programmer - Remote (US)

MMS is a data-focused clinical research organization (CRO) that prides itself on its innovative team and supportive culture. They are seeking a Senior Statistical Programmer who will be responsible for generating tables, listings, and graphs from clinical trial databases using SAS, while also leading study or small programming project teams.
BiotechnologyHealthcareLife ScienceHealth Care
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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

SAS programmingSDTM standardsADaM standardsE-Submission StandardsSystem Development Life CycleICH guidelinesData poolingBIMO outputsMS Office applicationsISO standards familiarityCRO understandingCommunication skillsProblem-solving skillsOrganizational skills

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

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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.

Funding

Current Stage
Late Stage
Total Funding
unknown
Key Investors
Lindsay Goldberg
2022-06-28Private Equity

Leadership Team

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Uma Sharma
Chief Executive Officer
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Christopher Schoonmaker
Chief Operating Officer
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Company data provided by crunchbase