Clinical Biostatistician, I

🔥 0 minutes ago

🇺🇸 United States – Remote

💵 $61.3k - $122.7k / year

⏰ Full Time

🟢 Junior

🟡 Mid-level

🧪 Clinical Research

🦅 H1B Visa Sponsor

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Logo of Abbott

Abbott

10,000+ employees

Founded 1888

🏥 Healthcare

⚕️ Healthcare Insurance

🧬 Biotechnology

Healthcare • Healthcare Insurance • Biotechnology

Abbott is a global healthcare company committed to advancing medical technologies and improving lives around the world. It offers a broad range of leading products in diagnostics, medical devices, nutrition, and branded generic medicines. Abbott's innovations such as the FreeStyle Libre glucose monitoring systems and BinaxNOW rapid antigen tests are transforming diabetes management and COVID-19 response. Through its partnerships and initiatives, Abbott aims to foster health equity, improve access to healthcare, and address critical health challenges like malnutrition and infectious diseases. Abbott is also dedicated to sustainability and social responsibility, striving to make life-changing technologies accessible and affordable.

📋 Description

• Collaborate with interdisciplinary, cross-functional teams to develop and establish evidence for oncology molecular tests • Assist the biostatistical function on project-level work under the direction of other statisticians • Provide input into analytical validity, clinical validity, clinical utility, health economics, and clinical experience study designs • Evaluate evidentiary requirements • Contribute to proposals, FDA pre-submissions, study protocols, endpoint selection, power and sample size calculations, and analysis plans • Review case report forms and data transfer requirements • Draft statistical analysis plans • Apply standard statistical methodology and programming • Monitor laboratory and clinical data quality • Develop evidence for clinical predictive models in clinical studies and trials • Conduct simulation studies • Communicate statistical results through tables, figures, listings, statistical analysis reports, clinical study reports, abstracts, manuscripts, regulatory submissions, presentations, and marketing collateral • Evaluate investigator-sponsored study designs and analysis plans, evidence for external molecular tests, and applicability of novel statistical techniques • Seek and integrate feedback from team members and managers • Support and comply with company Quality Management System policies and procedures • Uphold Abbott’s mission and values

🎯 Requirements

• Master’s degree in Biostatistics or related field • Working knowledge of theoretical and applied statistics • Strong statistical programming skills in SAS, R, or Python • Basic computer skills, including internet navigation and email usage • Working knowledge of Microsoft Office programs, including Word, Excel, PowerPoint, Outlook, Access, OneNote, and Publisher • Demonstrated ability to perform the essential duties with or without accommodation • Authorization to work in the United States without sponsorship • Preferred: 2 years of relevant work experience • Preferred: Experience developing products for approval by regulatory authorities such as FDA • Preferred: Experience in molecular diagnostic, drug, or medical device development; epidemiology; public health; or healthcare • Ability to travel up to 5% of working time, potentially including overnight/weekend travel • Ability to work at a computer, on a mobile device, or tablet and perform typing for approximately 90% of a typical working day

🏖️ Benefits

• Free medical coverage in the Health Investment Plan (HIP) PPO medical plan for qualifying employees in the next calendar year • Excellent retirement savings plan with a high employer contribution • Tuition reimbursement • Freedom 2 Save student debt program • FreeU education benefit • Career development with an international company • Health and wellness benefits

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