Job Description:
We are seeking an experienced Senior Statistical Programmer with strong expertise in ADaM and TLF generation for clinical trials. This role demands attention to detail, deep understanding of CDISC ADaM standards, and experience in programming both efficacy and safety datasets and outputs.
Core Responsibilities:
- Develop and maintain ADaM datasets in compliance with CDISC standards.
- Produce high-quality Tables, Listings, and Figures (TLFs) from ADaM datasets.
- Proactively identify inconsistencies between specifications (specs), Statistical Analysis Plans (SAPs), and shells during programming.
- Ensure accuracy, efficiency, and traceability of statistical outputs.
- Collaborate with biostatisticians and other stakeholders to interpret analysis requirements.
- Support pivotal studies (Phase II and Phase III) and lead programming efforts when required.
Required Skills and Experience (Must Have):
- 8+ years of hands-on experience in ADaM dataset creation and TLF programming.
- Strong attention to detail; ability to identify issues or inconsistencies in spec/SAP/shells.
- Excellent command of SAS programming, including advanced knowledge of SAS Macros.
- Proven experience in safety ADaM and TLF production (not just validation).
- Familiarity with CDISC ADaM guidelines and principles.
- Ability to work with at least 3–6 hours of overlap with US Eastern Time (preferably 9 AM – 12 PM EST).
Preferred Qualifications (Nice to Have):
- Experience in efficacy ADaM dataset production (not validation).
- Experience in efficacy TLF production (not validation).
- Strong capability in writing and reviewing ADaM specifications.
- Leadership experience in pivotal clinical trials (Phase II/III).
Tachyon Technologies Inc 
