Senior Statistical Programmer (Remote - Colombia)

mmsholdingsinc; Bogotá ciudad; A distancia; COP 94.270.000 - 141.405.000; Jornada completa

Descripción de la vacante

MMS is a data-focused clinical research organization seeking a Senior SAS Programmer to generate tables, listings, and graphs from clinical trial data. The role requires advanced SAS, SDTM and ADaM expertise and SDLC experience.

The position is remote-based within Colombia, with a Masters and 5+ years in statistical programming. Strong communication and knowledge of ICH/FDA/GCP standards are essential.

Formación

• Masters degree required for statistics roles.
• Minimum 5 years’ experience in Statistical Programming.
• Strong SAS, SDTM and ADaM knowledge; experience with ICH/FDA/GCP.

Responsabilidades

• Generate tables, listings, and graphs from clinical trial databases using SAS.
• Lead study or small programming project teams.
• Write specifications and ensure SDTM/ADaM compliance.

Conocimientos

SAS programming

SDLC

SAS Base

SAS Macros

E-Submission standards

SDTM standards

ADaM standards

MS Office

ICH & 21 CFR Part 11

ISO 9001:2000

Data pooling

BIMO outputs

Team leadership

Educación

Master's degree

Herramientas

SAS

Descripción del empleo

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 an 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.

We are looking for a full-time employee, remotelybased within any location in Colombia.

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.

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