Principal Biostatistician

🕒 February 17

🍂 Massachusetts – Remote

🍂 Massachusetts – Remote

💵 $160k - $220k / year

⏰ Full Time

🔴 Lead

🧪 Clinical Research

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eClinical Solutions

WebsiteLinkedInAll Job Openings

201 - 500 employees

Founded 2012

🧬 Biotechnology

💊 Pharmaceuticals

⚕️ Healthcare Insurance

💰 Private Equity Round on 2020-01

Biotechnology • Pharmaceuticals • Healthcare Insurance

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 consulting of statistics activities related to clinical trials • Fulfill the responsibilities of study statistician as required • Provide mentoring and QC of statistical programmer’s outputs; define analysis data specifications • Act as study statistician - interact with client and with clinical team including programmers, clinical data managers, clinical protocol manager, and other relevant personnel • Develop, review, and finalize the statistical analysis plan • Validate the programming deliverables and collaborate with applicable team members to rectify any issues related to statistical reporting and analysis • Develop randomization schedule, specifications, and guidelines • Where applicable, provide input in finalization of study specific data quality control plan • Ensure that all comments from the clinical team with regards to statistical report delivered for study specific deliverables are being addressed appropriately • Analyze the data and contribute to trial progression related decisions • Collaborate with team members for regulatory reviews, representations, and supporting data analyses

🎯 Requirements

• Master in Statistics, Biostatistics, or equivalent work experience preferred • Excellent knowledge of English • SAS® certification is preferred • 5+ years in Pharmaceutical/Biotechnology industry or equivalent statistical consulting and SAS programming role preferred • Strong experience with clinical study design development, analysis, and sample size determination • Strong knowledge of ICH guidelines and other guidelines such as GCP, and 21 CFR Part 11 from different regulatory agencies including FDA, and EMEA • Experience in developing statistical analyses reports, and in conducting statistical analyses and reporting for various trial level deliverables • Knowledge of coding dictionaries (WHO, COSTART, ICD-9, MedDRA) and clinical reporting processes • Knowledge of CDISC® related data models such as SDTM, and ADAM. Ability to develop ADAM model for analysis and reporting of clinical trial • Ability and experience of delegating tasks and leading projects

🏖️ Benefits

• Health insurance • Retirement plans • Paid time off • Flexible work arrangements • Professional development • Wellness programs