Senior Biostatistician

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September 30

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ResearchEd

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Education • Non-profit • Social Impact

ResearchEd is an education policy research nonprofit providing objective analysis, deep insights, and detailed recommendations for education institutions and research organizations seeking to support equitable student outcomes and promote community and economic development through education. ResearchEd conducts student-centered work, particularly focusing on underserved groups, and provides research, data capacity building support, and advocacy. Their mission is to empower action in education, aiming for equitable access to education as a catalyst for community success and social justice.

11 - 50 employees

Founded 2020

📚 Education

🤝 Non-profit

🌍 Social Impact

📋 Description

• Serve as a primary statistical representative for biometrics standalone projects or otherwise complex studies • Lead low to high complexity studies in various phases of development; provide senior oversight on low or moderate complexity studies • Effectively manage broad based projects such as NDA submissions or complex, multi-protocol programs, potentially coordinating activities across multiple projects simultaneously • Collaborate with internal and external project team personnel (Sponsor, external vendors, within Catalyst) to meet project deliverables and timelines for statistical data analysis and reporting • Interact with project team and line manager to identify project priorities and communicate activities and timelines to departmental management • Represent department and company in multi-disciplinary settings, including project team meetings, client meetings/presentations, and bid defense meetings • Provide statistical advice/recommendations regarding clinical study design, endpoints, sample size requirements, and statistical methodology for protocol and clinical study report • Develop and review statistical analysis plans based on study specific documents and sound statistical methodology • Assist in developing and maintaining ADaM specifications used in creating analysis datasets, tables, listings, and figures • Ensure the quality and integrity of data analysis and reporting by programming checks using SAS • Monitor project budgets related to scope of work and support project forecasting; meet with Finance to assess project budgets and report study status • Provide senior oversight to junior level biostatistics staff and contribute to departmental objectives and strategies

🎯 Requirements

• Master’s degree, equivalent, or higher in biostatistics or a related field • A satisfactory combination of education and experience may be accepted as a substitute for the specific education and experience listed above • Minimum of 5+ years of relevant work experience • Previous experience in pharmaceutical research or CRO setting required • Prior experience in multiple therapeutic areas required; Oncology preferred • Knowledge of clinical trial study design and multiple therapeutic areas • Ability to work independently on multiple, concurrent projects • Lead study team meetings as needed • Capable of conducting exploratory statistical analyses using statistical software packages • Proficient with Microsoft Office Suite • Excellent written and oral communication skills • Strong organizational, problem-solving, and analytical skills • Ability to manage priorities and workflow; proven ability to handle multiple projects and meet deadlines • Versatility, flexibility, and willingness to work within constantly changing priorities • Ability to deal effectively with a diversity of individuals at all organizational levels • Commitment to excellence and high standards; good judgment with ability to make timely and sound decisions • Ability to travel for meetings or training activities • Ability to program simple checks for ADaM or TLF review using SAS and/or R • Ensure quality and integrity of data analysis and reporting by programming checks using SAS • Experience developing and reviewing statistical analysis plans, ADaM specifications, and creating analysis datasets, tables, listings, and figures • Applicants must be authorized to work for ANY employer in the U.S.; employer will not sponsor visas