Senior Biostatistician - Remote Data Analytics Leader

eClinical Solutions, LLC; Mansfield (MA); On-site; USD 175,000 - 215,000; Full time

Benefits offered by this job

Remote work

Top Workplace USA Award

Job summary

eClinical Solutions is seeking Principal Biostatisticians to provide high level statistical consulting for clinical trials and to mentor statistical programmers. You will develop SAPs, randomization schedules, and study outputs while ensuring data quality and regulatory compliance.

Responsibilities include collaboration with clients and clinical teams, development of analysis datasets and tables, and ensuring timely, accurate reporting for trial deliverables within a remote-friendly environment.

Qualifications

• Master’s in Statistics or biostatistics preferred.
• SAS certification is preferred.
• Extensive experience in pharmaceutical/biotech statistical consulting and SAS programming.
• Strong study design, analysis, and sample size determination knowledge.
• Knowledge of SDTM/ADAM data models and CDISC standards.
• Experience with regulatory guidelines including ICH, GCP, and 21 CFR Part 11.
• Excellent written and verbal English communications and project leadership.

Responsibilities

• Provide high level statistical consulting for trials and protocols.
• Mentor and QC statistical programmer outputs; define analysis specs.
• Interact with clients and clinical teams to ensure correct data delivery.
• Develop, review, and finalize SAPs and randomization schedules.
• Validate programming deliverables and address reporting issues.
• Develop analysis datasets and trial tables/graphs as required.
• Ensure compliance with quality standards and procedures.

Skills

Biostatistics

SAS programming

Study design

Regulatory knowledge

English communication

Project leadership

CDISC SDTM/ADAM

IVRS randomization

ICH/GCP/21 CFR 11 knowledge

Education

Master's in Statistics/Biostatistics

SAS certification

Tools

SAS

Job description

eClinical Solutions is seeking Principal Biostatisticians to provide high level statistical consulting for clinical trials and to mentor statistical programmers. You will develop SAPs, randomization schedules, and study outputs while ensuring data quality and regulatory compliance.

Responsibilities include collaboration with clients and clinical teams, development of analysis datasets and tables, and ensuring timely, accurate reporting for trial deliverables within a remote-friendly environment.