Senior Statistical Programmer - Remote (US) Biometrics

MMS Holdings Inc; Northern (KY); Hybrid; USD 90,000 - 140,000; Full time

Job summary

MMS Holdings Inc is seeking a Senior Statistical Programmer to lead programming efforts for clinical trial data. You will generate tables, listings, and graphs from study databases using SAS, and apply SDTM/ADaM standards in submissions.

The role requires Masters in statistics or related field, 5+ years of experience in statistical programming, and strong knowledge of regulatory guidelines (FDA, GCP). Collaborative, detail-oriented professionals will thrive in MMS's team-focused environment.

Qualifications

• Masters required for Statistics roles.
• Minimum 5 years in Statistical Programming or similar field.
• Expert knowledge of scientific principles.
• Reputation as emerging leader with sustained performance.
• Familiarity with ISO 9001 and ISO 27001 preferred.
• Familiarity with 21 CFR Part 11, FDA, and GCP requirements.

Responsibilities

• Lead study or small programming project teams.
• Generate tables, listings, and graphs from trial data using SAS.

Skills

SAS programming

TFL generation

SDLC experience

SAS Macros

ADaM/SDTM knowledge

Data pooling for submissions

Lead programming projects

Communication skills

Regulatory knowledge

Education

Masters required for Statistics roles

Tools

SAS Base

SAS Macros

MS Office

Job description

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 aaward-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 ongenerating 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.