Senior Statistical Programmer (Remote - Mexico) Biometrics MEXICO

MMS Holdings Inc; México; Remote; MXN 540.000 - 900.000; Vollzeit

Zusammenfassung

MMS Holdings Inc is seeking a highly skilled Senior Statistical Programmer to work remotely from Mexico. This role requires strong SAS programming expertise, experience with SDTM/ADaM, and adherence to regulatory standards.

You will be responsible for generating tables, listings, and graphs from clinical trial data and may lead small programming project teams. Applicants should hold a Master’s in Statistics with at least five years in statistical programming, and demonstrate familiarity with ISO

Qualifikationen

• Masters required for Statistics roles.
• Minimum of 5 years' experience in Statistical Programming or similar field.
• Proficiency with MS Office applications.
• Hands-on experience with clinical trial and pharmaceutical development preferred.
• Familiarity with ISO 9001 and ISO 27001 standards preferred.
• Familiarity with 21 CFR Part 11, FDA, and GCP requirements.

Aufgaben

• Generate tables, listings, and graphs from clinical trial data using SAS.
• Lead study or small programming project teams.
• Ensure SDLC compliance for programming deliverables.
• Write specifications for SDTM/ADaM standards and ensure data quality.

Kenntnisse

SAS programming

SDLC understanding

SAS Base

SAS Macros

E-Submission standards

SDTM

ADaM

MS Office

ICH 21 CFR Part 11

GCP familiarity

Data pooling

Lead programming projects

Ausbildung

Master's degree in Statistics

Tools

SAS

Jobbeschreibung

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.

Kindly submit your CV in English!
We are looking for a full-time employee, remotelybased within any location in Mexico.

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.