Principal Biostatistician – FTE or Contract

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🍂 Massachusetts – Remote

🍂 Massachusetts – Remote

💵 $175k - $215k / year

⏰ Full Time

🔴 Lead

🧪 Clinical Research

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eClinical Solutions

WebsiteLinkedInAll Job Openings

201 - 500 employees

Founded 2012

💼 Consulting

🏥 Healthcare

🧬 Biotechnology

💰 Private Equity Round on 2020-01

Consulting • Healthcare • Biotechnology

eClinical Solutions is a clinical data management company that provides integrated data review and management solutions for the biotech and pharmaceutical industries. Their platform, elluminate, empowers organizations to modernize and automate their clinical data workflows, ensuring efficient data acquisition, management, and analysis. By leveraging advanced analytics and technology-driven approaches, eClinical Solutions helps streamline trial operations and improve productivity, enabling better decision-making in clinical research.

📋 Description

• Provide statistical consulting for clinical trial activities and fulfill study statistician responsibilities • Mentor and perform quality control of statistical programmers’ outputs and define analysis data specifications • Interact with clients and clinical teams, including programmers, clinical data managers, and clinical protocol managers • Develop, review, and finalize statistical analysis plans • Validate programming deliverables and resolve statistical reporting and analysis issues • Develop randomization schedules, specifications, and usage guidelines • Contribute to study-specific data quality control plans and data analysis/reporting • Develop, validate, and finalize tables and table shells for clinical study reports and study deliverables • Ensure clinical team comments on statistical reports are appropriately addressed • Analyze data and support trial progression decisions, including blinded data reviews and interim analyses • Collaborate on regulatory reviews, representations, exploratory, ad-hoc, and post-hoc analyses • Develop SAS programs for analysis datasets and clinical trial reporting, including tables, listings, graphs, queries, and patient profile reports • Ensure compliance with company and industry quality standards, guidelines, and procedures • Perform other duties as assigned

🎯 Requirements

• Master in Statistics or biostatistics preferred • SAS® certification preferred • 10+ years in the pharmaceutical/biotechnology industry or equivalent statistical consulting and SAS programming role preferred • Strong experience with clinical study design, analysis, and sample size determination • Experience developing randomization schedules, IVRS specifications, and usage guidelines • Excellent knowledge of English and clear, concise, accurate written and verbal communication • Ability to multitask with strong prioritization, planning, and organization skills • Ability and experience delegating tasks and leading projects • Experience working on multiple clinical protocols simultaneously • Ability to balance conflicting priorities • Strong knowledge of ICH, GCP, and 21 CFR Part 11 guidelines, including FDA and EMEA requirements • Experience developing statistical analysis reports and conducting statistical analyses for blinded data reviews and interim analyses • Knowledge of coding dictionaries including WHO, COSTART, ICD-9, and MedDRA • Knowledge of CDISC data models including SDTM and ADaM • Ability to develop ADaM models for clinical trial analysis and reporting • Thorough understanding of SDTM data structures

🏖️ Benefits

• Remote work • Work-life balance • Inclusive culture • Professional development and career growth opportunities • Equal opportunity employment • Diversity-focused workplace