Statistical Programmer III (R and SAS)

Coronado Research; United Kingdom; À distance; GBP 45 000 - 65 000; Plein temps

Résumé du poste

A clinical research organization is looking for a SAS Programmer III with strong SAS and R skills to support clinical trials remotely in the UK. The role involves programming SDTM and ADaM datasets, performing quality control, and collaborating with cross-functional teams. Candidates should have a Bachelor's degree in a related field and at least 3 years of experience in clinical programming. This is an excellent opportunity to enhance clinical programming skills while contributing to impactful patient outcomes.

Qualifications

• Minimum of 3 years experience programming clinical trial data.
• Experience in a CRO or pharmaceutical environment is preferred.
• Understanding of clinical trial processes and regulatory requirements.

Responsabilités

• Program safety and efficacy SDTM and ADaM datasets in compliance with CDISC standards.
• Identify data discrepancies in clinical trial datasets.
• Perform quality control checks on datasets and specifications.
• Collaborate with programmers and biostatisticians on project needs.

Connaissances

Creating and QCing SDTM and ADaM datasets

Strong working knowledge of SAS

Strong working knowledge of R

Analytical thinking

Effective communication skills

Attention to detail

Organisational skills

Formation

Bachelor’s degree in Statistics, Computer Science, Mathematics, or Life Sciences

Outils

Pinnacle21

Python

Description du poste

We are looking for a SAS Programmer III who can also program in R with a background in working across clinical trials, ideally with experience in oncology.

The successful candidate will be detail-oriented and motivated to deliver high-quality outputs, with a collaborative and customer-focused mindset. You will work closely with programmers, biostatisticians, and cross-functional teams to support effective data preparation, analysis, and reporting for clinical trials.

This is remote UK and you will need the right to work.

Key Responsibilities:

Data preparation: Program safety and efficacy SDTM and ADaM datasets in compliance with CDISC standards, including RECIST SDTM domains where applicable. Support data mapping, integration, and documentation activities to ensure datasets are analysis-ready.

Anomaly detection: Identify data discrepancies and anomalies within clinical trial datasets through structured review and QC activities. Investigate findings, understand their impact, and clearly communicate issues and resolutions to senior team members and non-technical stakeholders when required.

Quality Control: Perform quality control checks on SDTM/ADaM datasets, TLF outputs, and specifications to ensure accuracy, consistency, and compliance. Contribute to quality discussions and support the development of others through clear communication of QC findings.

Requirements Analysis:Review Statistical Analysis Plans (SAPs) and stakeholder requests, interpreting requirements into robust SAS and R programming solutions that deliver high-quality outputs.

Stakeholder communication: Collaborate with internal stakeholders including programmers and biostatisticians to understand project needs and contribute to study deliverables. Act as a shadow lead programmer and attend customer meetings alongside the Lead Programmer as required.

Regulatory Compliance:Ensure programming activities adhere to CDISC standards, Good Clinical Practice (GCP), ICH guidelines, and applicable regulatory requirements (FDA, EMA). Create and QC Define.xml files and validate datasets using industry-standard tools such as Pinnacle21.

Skills and Experience Required:

• Experience creating and QCing SDTM and ADaM datasets to CDISC standards.
• Development and QC of safety and efficacy Tables, Listings and Figures (TLFs).
• Bachelor’s degree in Statistics, Computer Science, Mathematics, Life Sciences, or a related discipline.
• Minimum of 3 years’ experience programming clinical trial data, ideally within a CRO or pharmaceutical environment.
• Strong working knowledge of SAS and R for data manipulation and analysis.
• Understanding of clinical trial processes, regulatory expectations, and data standards.
• Ability to diagnose data issues, apply analytical thinking, and resolve discrepancies.
• High attention to detail with a conscientious approach to quality and accuracy.
• Strong organisational skills with the ability to manage multiple tasks and priorities.
• Effective communication and interpersonal skills, with the ability to work independently and collaboratively.
• Experience with other programming languages such as Python, and exposure to Real World Data, would be advantageous.

This is a great opportunity for a Programmer III to continue developing their clinical programming expertise while contributing to high-quality clinical research that supports improved patient outcomes. If you are passionate about clinical data and programming, we encourage you to apply.