Senior Statistical Programmer (Remote - Colombia) Biometrics COLOMBIA

MMS Holdings Inc; Bogotá ciudad; Híbrido; COP 60.000.000 - 90.000.000; Jornada completa

Descripción de la vacante

MMS Holdings Inc. is seeking a senior Statistical Programmer to join our data-focused clinical research team.

This full-time role is remote within Colombia and requires expertise in SAS programming, CDISC SDTM/ADaM, and generating tables, listings, and graphs from trial data. Ideal candidates have a Master's degree, 5+ years of statistical programming experience in pharma/ CRO environments, strong problem-solving skills, and familiarity with 21 CFR Part 11, FDA, and GCP guidelines.

Formación

• 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.

Responsabilidades

• Lead study or small programming project teams.

Conocimientos

SAS programming

SAS Base

SAS Macros

SDTM

ADaM

E-Submission standards

Regulatory knowledge

Data pooling

MS Office

Leadership

Educación

Master's degree in Statistics/Biostatistics

Herramientas

MS Office

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 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 foster 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.