(Contract) Senior Statistical Programmers
The contract Senior Statistical Programmers will provide key role in developing, maintaining and validating clinical trial data analysis in one or more therapeutic areas (neurology, hematology, oncology, CNS), compliance with CDISC standards, compliance with regulatory requirements and efficient execution of programming deliverables. This position involves developing and validating datasets, tables, listings, and figures (TLFs) to support drug development and regulatory submissions for multiple indications at LLX’s clients. The openings are multiple and start very soon.
Key Responsibilities
- Develop and validate SDTM and ADaM datasets in compliance with CDISC standards.
- Generate tables, listings, and figures (TLFs) for clinical study reports.
- Ensure quality and timeliness of statistical analysis, reporting, and regulatory submission deliverables.
- Perform quality control (QC) checks on statistical programming deliverables
- Troubleshoot and resolve data and programming issues efficiently
- Collaborate with cross-functional team on clinical study planning and execution to ensure accurate data reporting.
- Demonstrate strong technical expertise to promote best practices related to programming environments, technology and programming skillsets.
- Manage and mentor Jr statistical Data Analyst programming teams, providing guidance and training.
- Ensure compliance with CDISC standards (SDTM, ADaM) and regulatory submissions requirements.
Qualifications
- Bachelor’s or Master’s degree in Statistics, or a related field.
- 7+ years of relevant work experience in biopharmaceutical, biotech, or CROs industry, with both early (Phase 1 and Phase 2) and late trial experience highly desired
- Proficiency in SAS programming and knowledge of R is a plus.
- Hands-on experience working with CDISC standards and programming based on raw datasets, SDTM, and ADaM datasets
- Demonstrates strong communication skills, both oral and written and Excellent problem-solving
- Ability to work in a cross-functional matrixed environment, and proactively influence teams with innovative clinical development strategy
Work Location
The Senior Statistical Programmers are remote role based in the US
Other Information:
- Contract Duration: 6-9 months with renewal per client
- Work Authorization: Green Card, US Citizen, or US work authorization required documentation with background check.