Senior Statistical Programming Specialist

About MMS

Are you ready to make a significant impact in clinical research? Join MMS, an award-winning, data-driven clinical research organization (CRO) committed to innovation and collaboration. We have been recognized as a Great Place to Work, due to our exceptional culture and dedication to employee satisfaction. With a global presence across four continents, we support the pharmaceutical, biotech, and medical device industries through a scientific approach to complex trial data and regulatory challenges. At MMS, we offer a collaborative and inclusive environment where your talents can shine. Be a part of shaping the future of clinical research with us!

Job Specific Skills :

• Expert in generating tables, listings, and graphs from clinical trial databases utilizing SAS.
• Experience applying the System Development Life Cycle (SDLC) in programming projects.
• Advanced proficiency in SAS programming, including SAS Base and SAS Macros.
• In-depth knowledge of E-Submission Standards, Guidelines, and Regulations.
• Thorough understanding of SDTM standards, including the ability to write detailed specifications.
• Proficient with ADaM standards, with experience in specification writing.
• Strong command of MS Office applications.
• Extensive knowledge of ICH, 21 CFR Part 11, and ISO 9001 : 2000 requirements.
• Experience in pooling datasets for regulatory submissions.
• Familiarity with BIMO outputs, define.xml, Reviewer's Guides, and SDSP.
• Capability to lead study or small programming project teams.

Job Requirements :