Principal Biostatistician, FSP

Job not on LinkedIn

🔥 6 minutes ago

🇺🇸 United States – Remote

⏰ Full Time

🔴 Lead

🧪 Clinical Research

🦅 H1B Visa Sponsor

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👻 Ghost score 25%

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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 one Phase I-IV clinical study across the region • Provide statistical and development support and influence for associated client trials • Provide expertise in processes, clinical development plans, concept sheets, and protocols • Potentially provide oversight of work supported by other vendors • Formulate integrated analytical approaches to mine data sources • Employ statistical methods, machine learning, and deep learning algorithms to discover actionable insights and automate processes • Participate in development of study protocols, including study design discussions and sample size calculations • Participate in exploratory data analyses to evaluate emerging study trends, support scientific decision-making, and generate insights throughout development • Apply advanced statistical methodologies, including mixed models and other complex modeling techniques, to support efficacy and longitudinal analyses • Design and execute simulation studies to evaluate study designs, operating characteristics, and statistical methodologies • Lead and contribute to efficacy analyses and interpretation of primary and secondary endpoints • Review CRFs and data review guidelines; develop Statistical Analysis Plans, including analysis dataset and TLF specifications • Perform statistical analyses and interpret statistical results • Lead study activities when called upon and provide strategic statistical guidance to cross-functional teams • Present statistical methodology, assumptions, and implications of decisions in clear, non-technical language • Collaborate with cross-functional teams and adapt as project priorities evolve

🎯 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 to support clinical development and decision-making • 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, and close collaboration with Statistical Programmers • 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 the ability to explain statistical methodology and its implications to both technical and non-technical audiences • Strong collaborative mindset with a commitment to delivering high-quality work under tight timelines • Ability to thrive in a dynamic environment, manage ambiguity, and adapt to changing priorities

🏖️ Benefits

• Consistent training, development and support • Significant professional growth • Professional development opportunities through staff development