Lead Statistical Programmer

ALSINOVA is actively hiring a Lead Statistical Programmer for a fully remote opportunity in US. You will work on programming activities across Phase I–III HIV & Immunology programs in a fast-paced environment, working closely with Biostatistics and Data Management teams.ResponsibilitiesLead end-to-end SDTM/ADaM dataset programming and validation across HIV study teamsServe as lead programmer, overseeing timelines, deliverables, and programming risk across multiple studiesDevelop and validate TLFs (tables, listings, figures) for CSRs, ISS/ISE, and interim analysesEnsure full CDISC compliance (SDTM, ADaM, Define.xml, ADRG/cSDRG) and Pinnacle 21 validationAuthor and review programming specifications, mock shells, and derivations aligned with the SAPSupport regulatory submissions (FDA/EMA), including IND/NDA/BLA deliverablesCollaborate cross-functionally with Biostatistics, Data Management, Clinical, and Regulatory teams to resolve submission-impacting issuesMentor and provide technical leadership to junior and mid-level programmersEstablish and maintain programming standards, SOPs, and QC processesRequirements8+ years SAS/R programming in clinical trials, including prior lead programmer experienceDemonstrated experience on HIV clinical trial programs preferredR proficiency mandatory (e.g., dplyr, tidyverse, ggplot2, R Shiny)Strong expertise in CDISC standards (SDTM, ADaM, Define.xml)Regulatory submission experience (FDA/EMA) requiredPhase I–III experience; infectious disease/virology background strongly preferredProven ability to lead and mentor programming teams