Summary

MMS Holdings (MMS) is an award-winning, data-focused clinical research organization (CRO) that supports pharmaceutical, biotechnology, and medical device companies with scientific approaches to complex trial data and regulatory submission challenges. Founded in 2006 by Dr. Uma Sharma, the company has grown from a one-person consultancy into a global organization with operations across four continents. MMS specializes in clinical strategy and execution, regulatory affairs and submissions, clinical programming and biostatistics, data management, medical writing, and pharmacovigilance services. The company leverages AI technology-enabled services and maintains an industry-leading customer satisfaction rating. With more than 950 colleagues worldwide, MMS is recognized for its scientific approach to drug development, flexibility, and customer-driven nature, having been named Best Contract Research Organization – Specialist Provider at the Scrip Awards and certified as a Top Workplace in the United States.

Job description

Job Specific Skills

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.

Job Requirements

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.

Requirements

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.

Company overview

MMS Holdings (MMS) is an award-winning, data-focused clinical research organization (CRO) that supports pharmaceutical, biotechnology, and medical device companies with scientific approaches to complex trial data and regulatory submission challenges. Founded in 2006 by Dr. Uma Sharma, the company has grown from a one-person consultancy into a global organization with operations across four continents. MMS specializes in clinical strategy and execution, regulatory affairs and submissions, clinical programming and biostatistics, data management, medical writing, and pharmacovigilance services. The company leverages AI technology-enabled services and maintains an industry-leading customer satisfaction rating. With more than 950 colleagues worldwide, MMS is recognized for its scientific approach to drug development, flexibility, and customer-driven nature, having been named Best Contract Research Organization – Specialist Provider at the Scrip Awards and certified as a Top Workplace in the United States.