Senior Statistical Programmer

Trialt; United States; Remoto; USD 110.000 - 170.000; Tempo pieno

Descrizione del lavoro

Trialt is expanding its Statistical Programming team to support international Phase I-IV clinical trials across therapeutic areas. Our programmers work with pharmaceutical, biotechnology, medical device and CRO clients across the US and Europe, on client-dedicated assignments or within a full-service biometrics team.

Project assignments are based on experience, expertise and current business needs, with opportunities to lead programming activities and collaborate with biostatisticians and data

Competenze

• Solid statistical programming experience within clinical research.
• Strong SAS programming skills, including DATA Step, PROC SQL and SAS Macro Language.
• Hands-on experience with SDTM, ADaM and TLF production and QC.
• Strong working knowledge of CDISC standards and controlled terminology.
• Understanding of traceability from source data through SDTM and ADaM to statistical outputs.
• Ability to work independently with protocols, SAPs, specifications and study documentation.
• Ability to manage programming activities for an assigned study or workstream.
• Strong communication, organisation and problem-solving skills.
• English at Upper-Intermediate level or higher.

Mansioni

• Independently develop and validate SDTM and ADaM datasets.
• Produce and QC complex tables, listings and figures.
• Interpret protocols, SAPs, dataset specifications and mock shells.
• Take ownership of programming activities for an assigned study or workstream.
• Review deliverables produced by other programmers and provide technical guidance.
• Investigate data issues, SAS log findings and validation findings.
• Support submission deliverables and study documentation.
• Estimate tasks, monitor timelines and communicate project status.
• Participate in client meetings and technical discussions.
• Collaborate with biostatisticians, data managers, medical writers and project teams.

Conoscenze

SAS programming

SDTM/ADaM

PROC SQL

Macro Language

TLF production

CDISC standards

Data QC

Problem solving

Communication skills

English level

Strumenti

Pinnacle 21

R

Python

Define-XML

Descrizione del lavoro

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

• Independently develop and validate SDTM and ADaM datasets.
• Produce and QC complex tables, listings and figures.
• Interpret protocols, SAPs, dataset specifications and mock shells.
• Take ownership of programming activities for an assigned study or workstream.
• Review deliverables produced by other programmers and provide technical guidance.
• Investigate data issues, SAS log findings and validation findings.
• Support submission deliverables and study documentation.
• Estimate tasks, monitor timelines and communicate project status.
• Participate in client meetings and technical discussions.
• Collaborate with biostatisticians, data managers, medical writers and project teams.

Required Qualifications

• Solid statistical programming experience within clinical research.
• Strong SAS programming skills, including DATA Step, PROC SQL and SAS Macro Language.
• Hands-on experience with SDTM, ADaM and TLF production and QC.
• Strong working knowledge of CDISC standards and controlled terminology.
• Understanding of traceability from source data through SDTM and ADaM to statistical outputs.
• Ability to work independently with protocols, SAPs, specifications and study documentation.
• Ability to manage programming activities for an assigned study or workstream.
• Strong communication, organisation and problem-solving skills.
• English at Upper-Intermediate level or higher.

Preferred Qualifications

• Previous experience as a Lead Programmer or readiness to take programming ownership.
• Experience with Define-XML, aCRF, SDRG and ADRG.
• Experience using Pinnacle 21 or similar validation tools.
• Experience supporting regulatory submissions.
• 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.