Principal Biostatistician, FSP

Job not on LinkedIn

🔥 4 minutes ago

🇺🇸 United States – Remote

⏰ Full Time

🔴 Lead

🧪 Clinical Research

🦅 H1B Visa Sponsor

This company has sponsored H1B visas in the past.

👻 Ghost score 25%

What it means: how likely this posting is sitting open without active hiring.How to read it: 60% or higher means we think this is a ghost. Lower scores are less of a worry.How we score it: age, reposts, open roles vs team size, how fast jobs close, and whether pay is listed.Fine print: an estimate from public data, not a judgment of the company. Real jobs can score high, so treat it as a hint, not a fact.

Apply Now

Find Similar Remote Jobs

Set Up Email Alert For New Jobs

📊 Check your resume score for this job

Improve your chances of getting an interview by checking your resume score before you apply.

Upload Resume

Clinical Outcomes Solutions

WebsiteLinkedInAll Job Openings

51 - 200 employees

💼 Consulting

🏥 Healthcare

🧬 Biotechnology

Consulting • Healthcare • Biotechnology

Clinical Outcomes Solutions is a global clinical outcomes consultancy that provides comprehensive support and services in all aspects of Clinical Outcome Assessment (COA) research. The company helps inform patient care by capturing the patient voice through innovative scientific methods. It guides organizations in navigating the complexities of clinical outcomes research by crafting strategies and solutions to capture accurate data. Trusted by pharmaceutical and biotechnology companies, the firm ensures regulatory compliance and optimized patient outcomes.

📋 Description

• Lead Phase I-IV clinical studies across the region • Provide statistical and development support for client trials • Contribute expertise to clinical development plans, concept sheets, protocols, and vendor oversight • Formulate integrated analytical approaches to mine data sources • Apply statistical methods, machine learning, and deep learning algorithms to discover actionable insights and automate repeatable processes • Participate in protocol development, study design discussions, and sample size calculations • Conduct exploratory data analyses to evaluate study trends and support scientific decision-making • Apply advanced statistical methodologies, including mixed models and complex modeling techniques • Design and execute simulation studies • Lead and contribute to efficacy analyses and interpretation of primary and secondary endpoints • Review CRFs and data review guidelines; develop SAPs, analysis dataset specifications, and TLF specifications • Perform statistical analyses and interpret results • Lead study activities and provide strategic statistical guidance to cross-functional teams • Present statistical methodology, assumptions, and decision implications in clear, non-technical language • Collaborate with teams to meet project goals and timelines

🎯 Requirements

• Master's degree in Statistics, Biostatistics, or a related discipline • 8-10 years of biostatistics experience supporting clinical trials within the pharmaceutical or biotechnology industry • 3-5 years of Study Lead experience working with cross-functional development teams • Extensive experience in study design, sample size determination, protocol development, SAP development, efficacy analyses, and preparation of clinical study reports, including integrated summaries for regulatory submissions (ISS/ISE) • Strong knowledge and practical application of advanced statistical methods, including mixed models, longitudinal analyses, and simulation methodologies • Demonstrated experience performing exploratory statistical analyses • Strong proficiency in R for statistical analyses, simulations, data visualization, and advanced modeling • Solid SAS programming skills, including QC of critical outputs, efficacy and safety tables • Strong knowledge of ICH guidelines and regulatory expectations • Solid understanding and implementation of CDISC standards for regulatory submissions • Experience generating ADaM specifications and performing programmatic review of analysis datasets • Regulatory submission experience (ISS/ISE) strongly desired • Excellent communication skills with technical and non-technical audiences • Ability to manage ambiguity, adapt to changing priorities, and deliver high-quality work under tight timelines

🏖️ Benefits

• Consistent training, development and support • Significant professional growth • Autonomy and ownership while working embedded with a pharmaceutical client