Senior Statistical Programmer (Remote - Mexico)

MMS; México; A distancia; MXN 900.000 - 1.200.000; Jornada completa

Descripción de la vacante

MMS is a award-winning, data-focused clinical research organization (CRO) seeking a senior Statistical Programmer based anywhere in Mexico. You will generate tables, listings, and graphs from clinical trial databases using SAS, and apply SDLC best practices to deliver robust programming deliverables.

Ideal candidates hold a Master’s degree, at least five years of experience in Statistical Programming, and demonstrate leadership on study teams, with strong knowledge of ICH, 21 CFR Part 11 and ISO

Formación

• Masters degree required for all Statistics roles.
• Minimum of 5 years’ experience in Statistical Programming or related field.
• Expert knowledge of scientific principles and concepts.
• Proven leadership in study or programming project teams.
• Proficiency with MS Office applications and clinical trial data.

Conocimientos

SAS programming

SDLC

SAS Base

SAS Macros

MS Office

ICH Part 11

ISO 9001

15 CFR Part 11

Data pooling

Lead programming teams

Educación

Master's degree in Statistics or related field

Herramientas

SAS

SAS Base

SAS Macros

MS Office

ICH Part 11

ISO 9001

21 CFR Part 11

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 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.

We are looking for a full-time employee, remotely based within any location in Mexico.

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.