Senior Statistical Programmer
Not Disclosed•Full-TimeOn-site
location_on7270, Peachtree Court, Sunflower Village, Canton Township, Wayne County, Michigan, 48187, United States
About MMS
MMS is an award-winning, data-focused clinical research organization (CRO) that supports the pharmaceutical, biotech, and medical device industries. We pride ourselves on a proven, scientific approach to complex trial data and regulatory submission challenges. Recognized as a Great Place to Work certified organization, we maintain an industry-leading employee retention rate and foster a collaborative, inclusive environment where employees can thrive.
With a global footprint across four continents, MMS is committed to shaping the future of clinical research while maintaining an industry-leading customer satisfaction rating. We are a supportive team where your contributions truly matter.
Application Requirements
Applicants must be legally authorized to work in the U.S. for any employer; we cannot sponsor visas (e.g., H-1B) or offer work authorization transfers at this time.
Learn More
Discover more about our exciting opportunities and why MMS is a great place to advance your career. Visit www.mmsholdings.com or follow MMS on LinkedIn.
Work location
Work model: On-site
7270, Peachtree Court, Sunflower Village, Canton Township, Wayne County, Michigan, 48187, United States
Canton Township, Michigan
Key Responsibilities
- check_circleWrite specifications for SDTM and ADaM standards
- check_circleLead study or small programming project teams
- check_circlePool data sets for regulatory submissions
- check_circleGenerate tables, listings, and graphs from clinical trial databases using SAS
- check_circleApply System Development Life Cycle (SDLC) for programming deliverables
- check_circlePrepare BIMO outputs, define.xml, Reviewer's Guides, and SDSP
- check_circleEnsure compliance with E-Submission Standards, ICH, and 21 CFR Part 11
Requirements
- verifiedMasters degree required
- verifiedMinimum 5 years experience in Statistical Programming
- verifiedMastery of SAS for generating tables, listings, and graphs
- verifiedAdvanced SAS programming, SAS Base, and SAS Macros
- verifiedAdvanced knowledge of E-Submission Standards, Guidelines and Regulations
- verifiedMastery of SDTM standards
- verifiedAdvanced knowledge of ADaM standards
- verifiedProficiency with MS Office applications
- verifiedAdvanced knowledge of ICH, 21CRF Part 11, and ISO 9001:2000 requirements
- verifiedApplicants must be legally authorized to work in the U.S.
- verifiedFamiliarity with ISO 9001 and ISO 27001 standards preferred
- verifiedFamiliarity with 21 CFR Part 11, FDA, and GCP requirements
- verifiedBasic understanding of CROs and scientific & clinical data/terminology
Nice to Have
Hands-on experience with clinical trial and pharmaceutical development. Familiarity with current ISO 9001 and ISO 27001 standards.
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Skills, education and keywords
Skills: Sas, Sas Base, Sas Macros, System Development Life Cycle, Adam, MS Office, Ich, 21CRF Part 11, Iso 9001:2000, Bimo Outputs.
Education: Masters required for all Statistics roles.
Frequently asked questions about Senior Statistical Programmer at MMS
What does a Senior Statistical Programmer at MMS do?expand_more
Day-to-day, the Senior Statistical Programmer at MMS will write specifications for sdtm and adam standards; lead study or small programming project teams; pool data sets for regulatory submissions; and generate tables, listings, and graphs from clinical trial databases using sas.
What are the requirements for this Senior Statistical Programmer role?expand_more
MMS is looking for candidates who meet the following requirements: Masters degree required; Minimum 5 years experience in Statistical Programming; Mastery of SAS for generating tables, listings, and graphs; Advanced SAS programming, SAS Base, and SAS Macros; Advanced knowledge of E-Submission Standards, Guidelines and Regulations; and Mastery of SDTM standards.
Where is the Senior Statistical Programmer role at MMS located?expand_more
Senior Statistical Programmer at MMS is based in 7270, Peachtree Court, Sunflower Village, Canton Township, Wayne County, Michigan, 48187, United States. This is a on-site role.
Is this Senior Statistical Programmer job remote, hybrid, or on-site?expand_more
MMS has listed this Senior Statistical Programmer role as on-site.
How much experience is required for this Senior Statistical Programmer role?expand_more
Senior Statistical Programmer at MMS typically requires 5+ years of relevant experience at the senior level.
What skills do you need for the Senior Statistical Programmer role at MMS?expand_more
Key skills for Senior Statistical Programmer at MMS include Sas; Sas Base; Sas Macros; System Development Life Cycle; Adam; MS Office; Ich; and 21CRF Part 11.
What education is required for Senior Statistical Programmer at MMS?expand_more
Educational requirements for this role: Masters required for all Statistics roles.
What category does the Senior Statistical Programmer role belong to?expand_more
Senior Statistical Programmer at MMS is part of the scientific & qa job category on Recrutus.