Statistical Programmer / Analyst

Trialt; United States; Remote; USD 90,000 - 130,000; Full time

Job summary

Trialt is expanding its Statistical Programming team to support international Phase I-IV clinical trials across therapeutic areas.

Our programmers work on projects for pharmaceutical, biotechnology, medical device and CRO clients across the US and Europe. Depending on the project and individual experience, you may join a client-dedicated assignment or work within a full-service biometrics team.

Qualifications

• 2+ years of statistical programming experience in clinical research.
• Experience with SDTM/ADaM datasets and CDISC standards.
• Familiar with SAS DATA Step, PROC SQL, and SAS Macro Language.
• Ability to review protocols and specifications, and ensure QC.
• Strong attention to detail and ability to meet timelines.

Responsibilities

• Develop and validate SDTM and ADaM datasets.
• Produce and QC tables, listings and figures.
• Work with protocols, SAPs, dataset specifications and mock shells.
• Review SAS logs and investigate programming or data discrepancies.
• Support submission-related deliverables and project standards.
• Maintain documentation and provide progress updates.
• Collaborate with statisticians, data managers, and project teams.

Skills

SAS programming

SDTM/ADaM

CDISC standards

QA / validation

Data management

Tools

Pinnacle 21

R

Python

SAS Macro Language

Job description

Trialt is expanding its Statistical Programming team to support international Phase I-IV clinical trials across a range of therapeutic areas.

Our programmers work on projects for pharmaceutical, biotechnology, medical device and CRO clients across the US and Europe. Depending on the project and individual experience, you may join a client-dedicated assignment or work within a full-service biometrics team.

Project assignments are based on your experience, expertise and current business needs.

What You Will Do

• Develop and validate SDTM and ADaM datasets.
• Produce and independently QC tables, listings and figures.
• Work with protocols, SAPs, dataset specifications and mock shells.
• Review SAS logs and investigate programming or data discrepancies.
• Support the preparation and QC of submission-related deliverables.
• Follow project-specific and company programming standards.
• Maintain clear documentation and provide regular progress updates.
• Collaborate with statistical programmers, biostatisticians, data managers and project teams.

Required Qualifications

• At least 2 years of statistical programming experience in clinical research.
• Good SAS programming skills, including DATA Step, PROC SQL and SAS Macro Language.
• Practical experience with SDTM, ADaM and/or TLF programming.
• Working knowledge of CDISC standards and clinical trial data.
• Understanding of production, independent validation and QC processes.
• Ability to work with programming specifications and study documentation.
• Strong attention to detail and ability to meet agreed timelines.
• English at an intermediate level or higher.

Preferred Qualifications

• Experience with both SDTM and ADaM.
• Experience using Pinnacle 21 or similar validation tools.
• Familiarity with regulatory submission deliverables.
• Experience with R or Python.
• Previous experience in an international CRO, FSP or sponsor environment.

Recruitment Process

We keep the recruitment process practical and straightforward.

• A short introductory screening call.
• One or two interview rounds, depending on the project. For client-dedicated assignments, the second round may be conducted by the client.

Working Model

• Fully remote position.