Senior Statistical Programmer - Remote Europe/LATAM

Emmes Group; Manchester; Remote; GBP 90,000 - 120,000; Full time

Job summary

Emmes Group is seeking a Principal Statistical Programmer to lead SDTM and ADaM programming for clinical trials and regulatory submissions. You will design, validate, and maintain datasets and tables, while mentoring junior programmers and ensuring adherence to CDISC, ICH, FDA/EMA standards.

The role requires strong SAS expertise and extensive experience with regulatory submissions, collaborating with Biostatistics, Data Management, and Clinical teams to deliver timely outputs.

Qualifications

• 7-9 years of statistical programming in pharma/biotech/CRO.
• Expert SAS proficiency across Base, Macro, and SQL.
• In-depth CDISC SDTM and ADaM experience.
• Experience supporting regulatory submissions (FDA/EMA).
• Strong communication and collaboration with cross-functional teams.

Responsibilities

• Lead development, validation, and maintenance of SDTM/ADaM datasets and documentation.
• Program TLFs for study reports, publications, and submissions.
• Review SAPs to ensure correct implementation in code.
• Act as lead programmer on multiple studies and mentor junior staff.
• Ensure compliance with CDISC, FDA, EMA standards and internal SOPs.
• Prepare submission-ready datasets and define.xml files for authorities.

Skills

SAS Base

SAS Macro

SAS SQL

CDISC SDTM

CDISC ADaM

GCP & 21 CFR11

Regulatory submissions

Problem solving

Communication

Education

Bachelor's Degree in Computer Science/Statistics/Mathematics/Life Sciences

Master's degree in a related field

Tools

Pinnacle 21

OpenCDISC

define.xml tooling

Job description

Emmes Group is seeking a Principal Statistical Programmer to lead SDTM and ADaM programming for clinical trials and regulatory submissions. You will design, validate, and maintain datasets and tables, while mentoring junior programmers and ensuring adherence to CDISC, ICH, FDA/EMA standards.

The role requires strong SAS expertise and extensive experience with regulatory submissions, collaborating with Biostatistics, Data Management, and Clinical teams to deliver timely outputs.