Sign upLog in

Senior Statistical Programmer - Remote

MMS

Canton, MI(remote)

Apply
JOB DETAILS
JOB TYPE
Full-time
SKILLS
Accreditation Standards, Biotech and Pharmaceutical, Case Report Form (CRF), Clinical Data, Clinical Research, Clinical Trial, Code of Federal Regulations, Communication Skills, Contract Research Organization (CRO), Customer Satisfaction, Data Sets, Drug Development, Employee Retention, FDA Requirements, GCP (Good Clinical Practices), ICH Regulations, ISO (International Organization for Standardization), ISO 9001, LinkedIn, Medical Equipment, Microsoft Office, Needs Assessment, Organizational Skills, Problem Solving Skills, Regulations, Regulatory Submissions, Requirements Management, Scientific Principles, Software Development Lifecycle (SDLC), Statistical Analysis System (SAS), Statistical Programming Languages, Statistics, Team Player, Wireless Multimedia Messaging Service, Writing Skills, XML (EXtensible Markup Language)
LOCATION
Canton, MI
POSTED
Today
About MMS
Are you looking to join a company where your contributions truly matter, and where you'll be part of a supportive, innovative team? MMS is a award-winning, data-focused clinical research organization (CRO). We pride ourselves on being a Great Place to Work certified organization, recognized for our exceptional culture and industry best employee retention rate. We support the pharmaceutical, biotech, and medical device industries with our proven, scientific approach to complex trial data and regulatory submission challenges. With a global footprint across four continents, MMS not only maintains an industry-leading customer satisfaction rating but also fosters a collaborative and inclusive work environment where employees can thrive. Join us at MMS and be part of a team that is shaping the future of clinical research.
 
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.

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.

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.  

Powered by JazzHR

About the Company

M

MMS

Resume Resources

Free Resume TemplatesFree Resume Builder