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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.

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.

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.

The Senior Statistical Programmer will program and validate datasets for clinical trials, oversee deliverables, manage projects, and ensure compliance with industry standards. Requires strong skills in SAS and R for statistical programming.

Seeking a Statistical Programmer II/III to develop and maintain statistical programs primarily using R and SAS for clinical trial data analysis, collaborating with clinical teams to ensure compliance and support submissions.

The Principal Biostatistician Consultant will oversee statistical aspects of drug development, provide statistical support, manage project timelines, mentor team members, and contribute to process improvements.

The Senior Statistical Programmer Consultant will manage programming tasks for clinical trials, oversee deliverables, and validate datasets while ensuring compliance with industry standards.

The Principal Biostatistician Consultant leads statistical methodologies and analysis for oncology clinical trials, contributing to regulatory submissions and collaborating with cross-functional teams.

The role involves leading statistical programming activities, mentoring programmers, overseeing clinical programming deliverables, and ensuring quality and compliance in regulatory submissions.