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, https://jobeax.com/link/UE15fSbKOKY7scWI, 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

➢ Led multiple studies on end-to-end programming while serving as the primary point of contact for clients.

➢ 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.

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

Professional Skills

➢ Minimum 8+ 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
➢ Detail oriented, ability to multitask with strong prioritization, planning and organization skills.
➢ Excellent team player

Technical Skills

➢ Advanced SAS programming expertise in data extraction, integration, analysis, reporting, and automation.
➢ Proficient in Base SAS, PROC SQL, Macro Programming, ODS, SAS/GRAPH, SAS/STAT, SAS/CONNECT, and SAS/ACCESS.
➢ Extensive experience with SAS reporting procedures, including PROC SQL, PROC REPORT, PROC SUMMARY / PROC Means, PROC FREQ, and PROC TRANSPOSE, in clinical research environments.
➢ Skilled in working with relational databases, SAS performance optimization, and process automation through batch, shell scripting and AI tools.
➢ Experienced in R programming (tidyverse, dplyr, admiral, rtables ggplot2, xportr, flextable) and Git-based version control (GitHub, GitLab).
➢ Experienced in developing Tables, Listings, and Graphs (TLGs) using SAS and R for clinical trial analysis and reporting.

Statistical Programmer Sr

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