Senior Biostatistician

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⛰️ Colorado – Remote

⛰️ Colorado – Remote

💵 $120k - $150k / year

⏰ Full Time

🟠 Senior

🧪 Clinical Research

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CPC

WebsiteLinkedInAll Job Openings

51 - 200 employees

🔧 Hardware

☁️ SaaS

IT Services • Hardware • SaaS

CPC is a trusted tech partner that specializes in IT support and IT services, providing a wide range of solutions including sales and maintenance of new, used, and factory recertified computer hardware and software. Established in 1962, CPC leverages a deep bench of engineers and consultants to offer innovative and efficient IT solutions tailored to both businesses with or without internal IT departments. With a focus on value, innovation, reputation, and excellence, CPC supports various industries including remote work, healthcare, and manufacturing, ensuring businesses stay up, running, and protected. The company partners with leading tech brands such as Citrix, IGEL, LG, Nutanix, Arctic Wolf, NoMachine, Zebra Technologies, and DELL, and offers both new and refurbished equipment. CPC is committed to enhancing business operations through effective IT solutions and services.

📋 Description

• Serve as the lead biostatistician on clinical study teams, accountable for statistical deliverables, quality, and timelines. • Provide mentorship and oversight to statisticians and statistical programmers. • Communicate project progress, risks, and resource needs to leadership. • Ensure alignment of project execution with departmental and organizational goals. • Lead the statistical design of clinical studies, including protocol development and statistical methodologies. • Perform and review sample size and power calculations. • Develop, review, and finalize statistical analysis plans (SAPs). • Recommend innovative statistical approaches, endpoints, and reporting strategies aligned with study objectives. • Provide statistical input into electronic data capture (EDC) design. • Partner with data management to define edit checks and ensure high-quality data collection. • Ensure study data supports interim and final analyses and regulatory requirements. • Develop, validate, or oversee statistical programming using SAS and other tools (e.g., R, Python). • Review outputs for accuracy, quality, and compliance with standards. • Lead preparation and review of interim analyses, final study reports, and regulatory submissions. • Communicate complex statistical concepts and results to non-statistical stakeholders and senior leadership. • Ensure compliance with GCP, FDA, ICH, and other applicable regulatory standards.

🎯 Requirements

• PhD or Master’s degree in Biostatistics, Statistics, or related field with at least 5 years of experience in clinical trial data analysis • Demonstrated programming proficiency in SAS (version 9.0 or higher) • Experience supporting Phase I–III clinical trials • Strong knowledge of ICH guidelines and regulatory requirements; familiarity with FDA submission processes • Familiarity with CDISC standards (e.g., SDTM, ADaM) for regulatory submissions • Proven leadership experience managing projects and mentoring team members • Proficiency with Microsoft Office tools (Word, Excel, PowerPoint) • Strong analytical, organizational, and problem-solving skills with high attention to detail • Excellent communication and interpersonal skills, with the ability to convey complex statistical concepts clearly • Ability to manage multiple trials and priorities simultaneously with minimal disruption to productivity

🏖️ Benefits

• Comprehensive benefits package (medical, dental, vision, life, STD, LTD etc.) • Matching 401(k) plan (dollar for dollar up to 4% of your eligible compensation, fully vested immediately) • 11 paid holidays • 15 - 25 vacation days based on years of service • Paid sick time (2.67 hours accrued bi-weekly up to a maximum of 80 hours) • Monthly fun events (e.g. team building activities, games, charitable events, potlucks, picnics) • Flexible and remote work schedules