OVERVIEW
Experienced Statistical Programmer with expertise in supporting multiple clinical studies through the development, validation, and delivery of high-quality statistical programming outputs. Proficient in SAS (Base SAS, SAS/STAT, and Macro Language) and CDISC standards, including SDTM, ADaM, and TLF development for regulatory submissions. Skilled in creating analysis datasets, safety and efficacy tables, listings, figures, Define.xml, and submission packages compliant with FDA, PMDA, and EMA requirements. Strong knowledge of the clinical drug development process, data automation, safety reporting, DSUR/PSUR deliverables, and Pinnacle 21 validation. Proven ability to collaborate with internal stakeholders, proactively resolve programming issues, and ensure timely, compliant, and accurate study deliverables. Use of R and AI tools to augment, enhance day to day programming is a huge plus.
KEY TASKS & RESPONSIBILITIES
- ➢ Develop specifications and SAS programs for SDTM datasets and clinical data analysis deliverables.
- ➢ Create specifications and SAS programs for ADaM datasets supporting trial-level reporting and integrated safety and efficacy analyses.
- ➢ Develop, maintain, and validate Tables, Listings, and Graphs (TLGs) based on biostatistical requirements and Statistical Analysis Plans (SAPs).
- ➢ Program and QC data listings, summaries, graphs, and statistical models as required.
- ➢ Design and maintain reusable SAS macros to support Phase I–IV clinical trial reporting.
- ➢ Generate submission-ready datasets and output using industry standards, SDLC practices, and regulatory requirements.
- ➢ Collaborate with cross-functional teams to ensure timely delivery of high-quality study outputs.
- ➢ Maintain project documentation in compliance with SOPs, processes, and quality standards.
- ➢ Ensure adherence to eClinical Solutions and industry guidelines, procedures, and regulatory expectations.
- ➢ Ability to independently write R programs and convert SAS programs to R programs using AI tools to create datasets and TLFs.
Show the full description
Education & Experience
- ➢ Basic Science/Bachelor of Science degree (Master in Statistics or related science preferred) in health-related fields, computer science or equivalent experience preferred.
- ➢ SAS Certified
- ➢ R programming experience is a plus
- ➢ Knowledge and experience in using AI to gain programming efficiencies is a plus
- ➢ Excellent written and verbal communication skills in English
Professional Skills
- ➢ Minimum 4-5 years in Pharmaceutical/Biotechnology industry or equivalent IT consulting role preferred.
- ➢ Strong experience in preparations for NDA filings
- ➢ Strong knowledge of E6, E3, E9 guidelines, 21 CFR Part 11 and clinical trial methodologies
- ➢ Knowledge of coding dictionaries (WHO, COSTART, ICD-9, MedDRA)
- ➢ Knowledge of CDISC® related data models like SDTM, and ADAM.
- ➢ Experience of working on multiple clinical protocols at the same time.
- ➢ Excellent verbal and written communication skills
