Principal Biostatistician, R Proficiency

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🔥 0 minutes ago

🇺🇸 United States – Remote

⏰ Full Time

🔴 Lead

🧪 Clinical Research

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Clinical Outcomes Solutions

WebsiteLinkedInAll Job Openings

51 - 200 employees

🧬 Biotechnology

💊 Pharmaceuticals

⚕️ Healthcare Insurance

Biotechnology • Pharmaceuticals • Healthcare Insurance

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

• Our Principal Biostatisticians provide statistical and development support and influence for the associated client's trials providing expertise into processes, clinical development plans, concept sheets and protocols, as well as potentially providing oversight of work supported by other vendors. • You will formulate integrated analytical approach to mine data sources, employ statistical methods, machine learning & deep learning algorithms to discover actionable insights and automate process for reducing effort and time for repeated use. • Participating in the development of study protocols, including study design discussions and sample size calculations. • Participating in exploratory data analyses to evaluate emerging study trends, support scientific decision-making, and generate insights throughout the course of development. • Leading and contributing to efficacy analyses and interpretation of primary and secondary endpoints. • Reviewing CRFs and data review guidelines; developing Statistical Analysis Plans (SAPs), including analysis dataset and TLF specifications. • Performing statistical analyses and interpreting statistical results. • Leading study activities when called upon and providing strategic statistical guidance to cross-functional teams. • Utilizing strong communication skills to present statistical methodology, assumptions, and the implications of decisions in clear, non-technical language. • Serving as a collaborative team player with a willingness to go the extra distance to meet project goals and timelines.

🎯 Requirements

• Master's degree in Statistics, Biostatistics, or a related discipline. PhD strongly preferred. • 8-10 years of biostatistics experience supporting clinical trials within the pharmaceutical or biotechnology industry. CRO experience strongly preferred. • 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

• Our commitment to developing our staff is only surpassed by our commitment to advancing treatment options available to patients. • Cytel provides consistent training, development and support.