Senior Statistical Programmer - Remote

Senior Statistical Programmer - Remote (US)

Join to apply for the Senior Statistical Programmer - Remote (US) role at MMS.

MMS is an award‑winning, data‑focused clinical research organization (CRO) recognized as a Great Place to Work. We serve the pharmaceutical, biotech, and medical device industries with a scientific approach to complex trial data and regulatory submission challenges. With a global footprint across four continents, MMS maintains an industry‑leading customer satisfaction rating and fosters a collaborative, inclusive environment where employees can thrive.

Join us at MMS and be part of a team shaping the future of clinical research.

• Mastery and training in 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 training 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, 21
  
  CRF 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
• Hands‑on experience with clinical trial and pharmaceutical development preferred
• 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
• 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

• Mid‑Senior level

• Full‑time

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