Overview
Remote
$100,000 - $160,000
Full Time
Skills
SDTM
ADaM
CDISC
SAS
AWS
Azure
Job Details
We are looking for an experienced Biostatistical Programmer with strong expertise in CDISC standards (SDTM and ADaM). The role involves developing, validating, and maintaining datasets and statistical outputs to support clinical trial submissions. You will collaborate with biostatisticians, data managers, and clinical teams to ensure high-quality deliverables compliant with regulatory requirements.
Key Responsibilities
- Develop, validate, and maintain SDTM and ADaM datasets in compliance with CDISC standards and regulatory guidelines (FDA, PMDA, EMA).
- Program and validate tables, listings, and figures (TLFs) to support clinical study reports (CSRs) and regulatory submissions.
- Ensure programming deliverables meet quality, timeline, and compliance requirements.
- Collaborate with statisticians and clinical teams to understand analysis specifications and translate them into efficient programming solutions.
- Perform data quality checks and resolve data issues in collaboration with data management.
- Contribute to standardization efforts (macros, libraries, SOPs, and best practices).
- Provide programming support for ad-hoc requests, exploratory analyses, and regulatory audits.
Required Skills & Qualifications
- Bachelor s/Master s degree in Biostatistics, Computer Science, Life Sciences, or related field.
- Strong programming skills in SAS (Base SAS, SAS/STAT, SAS/Macro), Python and R.
- Hands-on experience in creating and validating SDTM and ADaM datasets.
- Solid understanding of CDISC standards and regulatory submission requirements.
- Knowledge of clinical trial processes, ICH-Google Cloud Platform guidelines, and statistical concepts.
- Strong problem-solving, attention to detail, and documentation skills.
- Hands on experience with Cloud environments like AWS and Azure.
Good to Have (Optional)
- Experience with Define.xml, Pinnacle 21, and e-submission tools.
- Exposure to Life science, pharma/clinical research environments or CRO settings.
- Familiarity with safety and efficacy analysis in clinical trials.
Employers have access to artificial intelligence language tools (“AI”) that help generate and enhance job descriptions and AI may have been used to create this description. The position description has been reviewed for accuracy and Dice believes it to correctly reflect the job opportunity.