Remote Lead Statistical Programmer (SDTM/ADaM)

Trialt; United States; Remote; USD 110,000 - 170,000; 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 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

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.

Responsibilities

• 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.

Skills

SAS programming

SDTM/ADaM

PROC SQL

Macro Language

TLF production

CDISC standards

Data QC

Problem solving

Communication skills

English level

Tools

Pinnacle 21

R

Python

Define-XML

Job description

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