Senior Statistical Programmer - Remote Europe/LATAM

Emmes Group; Bogotá; A distancia; COP 286.615.000 - 541.384.000; Jornada completa

Descripción de la vacante

Emmes Group is seeking a Principal Statistical Programmer to lead SDTM/ADaM development, programming complex TLFs, and ensure regulatory submission readiness. You will mentor junior programmers and collaborate with Biostatistics, Data Management, and Clinical teams to deliver timely outputs.

The role emphasizes governance of CDISC standards, ICH GCP knowledge, and strong communication across study teams, with remote work options available for Europe or LATAM.

Formación

• Bachelor's or Master's degree in Computer Science, Statistics, Mathematics, Life Sciences or related field.
• 7-9 years in statistical programming within pharma/biotech/CRO.
• Expert SAS Base, Macro, and SQL proficiency.
• In-depth experience with CDISC SDTM and ADaM standards.
• Proven track record supporting clinical trial reporting and regulatory submissions.
• Strong understanding of ICH GCP, 21 CFR 11, FDA/EMA expectations.
• Excellent problem solving and attention to detail.
• Strong communication and collaboration skills.

Responsabilidades

• Lead the development, validation, and maintenance of SDTM/ADaM datasets and documentation.
• Program complex Tables, Listings, and Figures for study reports and submissions.
• Review SAPs to ensure correct implementation in code.
• Serve as lead programmer on multiple studies and coordinate with internal teams and CROs.
• Provide technical oversight and mentoring to junior programmers and contractors.
• Ensure compliance with CDISC, FDA/EMA standards and internal SOPs.
• Prepare submission-ready datasets, define.xml, and reviewer guides for regulatory authorities.
• Support ISS/ISE analyses for NDA/BLA/MAA submissions.

Conocimientos

SAS Base

SAS Macro

SAS SQL

CDISC SDTM

CDISC ADaM

Regulatory knowledge

Communication skills

Educación

Bachelor's or Master's in Computer Science, Statistics, Mathematics, Life Sciences

Herramientas

Pinnacle 21

OpenCDISC

define.xml generators

Descripción del empleo

Emmes Group is seeking a Principal Statistical Programmer to lead SDTM/ADaM development, programming complex TLFs, and ensure regulatory submission readiness. You will mentor junior programmers and collaborate with Biostatistics, Data Management, and Clinical teams to deliver timely outputs.

The role emphasizes governance of CDISC standards, ICH GCP knowledge, and strong communication across study teams, with remote work options available for Europe or LATAM.