MMS

Regulatory compliance and data solutions provider

Senior Statistical Programmer

Quantitative Biology & BiostatisticsConfirmed live in the last 24 hours

Full-timeRemote in ArgentinaNo salary listed

About the Job

Requirements

A master's degree is required for all Statistics roles.
At least 5 years of experience in Statistical Programming or a similar field is required.
Expert knowledge of scientific principles and concepts is required.
A reputation as an emerging leader in the field with sustained performance and accomplishment is required.
Proficiency with Microsoft Office applications is required.
Good communication skills and willingness to work with others to clearly understand needs and solve problems are required.
Excellent problem-solving skills are required.
Good organizational and communication skills are required.
Familiarity with 21 CFR Part 11, FDA, and Good Clinical Practice requirements is required.
A basic understanding of contract research organizations, scientific and clinical data and terminology, and the drug development process is required.
Mastery and training in generating tables, listings, and graphs from clinical trial databases using SAS are required.
Use of the System Development Life Cycle for programming deliverables is required.
Advanced user proficiency in SAS programming, SAS Base, and SAS Macros is required.
Advanced knowledge of e-submission standards, guidelines, and regulations is required.
Mastery and training in SDTM standards, including the ability to write specifications, are required.
Advanced knowledge of ADaM standards, including supporting specification writing, is required.
Advanced knowledge of ICH, 21 CFR Part 11, and ISO 9001:2000 requirements is required.
Advanced experience pooling data sets for submissions is required.
Advanced experience with BIMO outputs, define.xml, Reviewer's Guides, and SDSP is required.

Responsibilities

Lead study or small programming project teams.

Desired Qualifications

Hands-on experience with clinical trials and pharmaceutical development is preferred.
Familiarity with current ISO 9001 and ISO 27001 standards is preferred.

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.

Kindly submit your CV in English!

We are looking for a full-time employee, remotely based within Argentina.

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.

Please consider your application unsuccessful if we do not reach out to you within 14 days of your submission.

About the Company

MMS

Regulatory compliance and data solutions provider

MMS Holdings is a global contract research organization (CRO) focused on regulatory compliance and data-driven solutions for pharmaceutical and biotech sponsors. It delivers services such as regulatory submissions, clinical trial management, data analytics, and medical writing through a service-based model that relies on established processes and experienced advisors. Its work is contract-based, often long-term, aimed at helping clients meet regulatory requirements, run trials efficiently, and advance therapies under FDA guidance. The company differentiates itself with a science-first approach, a strong track record (97% client satisfaction), and involvement in complex areas like enabling MDMA-assisted therapy research, underscoring a commitment to high-quality, compliant outcomes for sponsors globally.

Company size: 1,001-5,000
Company stage: Not listed
Total funding: Not listed
Headquarters: Canton, Michigan
Founded: 2006

Recently Posted Jobs

Explore more opportunities at MMS

See more jobs