Top Tech Jobs & Startup Jobs in Boston, MA

Lead and mentor a statistical programming team to deliver SDTM/ADaM datasets and TLFs for oncology clinical trials, ensure CDISC compliance, support regulatory submissions (FDA/EMA), oversee QC and vendor deliverables, and drive automation and programming standards.

Provide statistical leadership for oncology Phase I-III trials: develop SAPs/protocols/CSRs, design efficacy and safety analyses, oversee SDTM/ADaM datasets and TLFs, support interim/DMC and adaptive analyses, contribute to regulatory submissions, and mentor junior statisticians.

Manage end-to-end execution of a medical device clinical sleep/respiratory study: ensure protocol, GCP and ISO 14155 compliance; oversee timelines, budgets, risk-based monitoring, data review, deviations management, and mentor junior staff while liaising with sponsor and cross-functional teams.

Lead statistical design and analysis for late-phase oncology studies, including protocol development, sample size, SAPs, oversight of data quality, tables/figures, mentoring statisticians, and coordinating project deliverables while ensuring regulatory compliance.

Lead and support statistical programming deliverables for clinical studies: implement protocol programming, ensure high-quality outputs and documentation, write/implement specifications, enforce standards and compliance, contribute best practices, manage tasks, communicate risks, and collaborate with statisticians, data managers, and study leads.

Lead statistical strategy and deliverables for Immunology clinical trials. Author and review SAPs, ADS, and clinical study report sections; review analysis outputs; collaborate with Clinical, Programming, Data Management, and Regulatory teams; mentor programmers; ensure FDA/ICH/GCP compliance.

Client-facing data scientist supporting clinical data transfer, ETL, validation, analysis, and Power BI dashboards. Build R scripts, assist data harmonization, support internal tools and basic web interfaces while working with cross-functional teams on clinical trial data.

Develop and validate SDTM and ADaM datasets using R following CDISC standards; support TLF generation, QC checks, regulatory deliverables, automation and R-based pipelines; collaborate with statisticians, data managers, and clinical teams.

Lead statistical programming strategy and teams for clinical studies, oversee development/validation of SDTM/ADaM datasets and TLFs, ensure regulatory submission readiness (eCTD), drive SAS/R workflows, automation, and cross-functional collaboration with biostatistics, data management, and regulatory teams.

Lead statistical programming for oncology trials: develop and validate SDTM/ADaM datasets, produce TLFs, provide SAS programming expertise, manage study timelines and vendors, prepare submission-ready outputs (define.xml, annotated CRFs), and ensure regulatory compliance for FDA/EMA/PMDA submissions.