Job Title: Project Manager Department: Biometrics/Project Management Responsibilities: Manages Biometrics project teams from study start-up through study closeout; departments include Data Management, Biostatistics, Statistical Programming, and Medical Writing. Manages multiple projects ranging in size and complexity from single service studies to large full scope biometrics projects, global projects and/or programs, with minimal oversight from supervisor. Serves as the primary liaison between clients, vendors, and project teams. Promotes team communication and cross functional collaboration in order to promote team spirit. Establishes and maintains relationship between client, vendors and project team, to encourage repeat and/or new business. Coordinates and leads team meetings. Creates and distributes agendas and minutes. Generates and maintains timelines, milestones, and action items. Manages project financials; estimates monthly accruals and initiates timely invoice generation. Identifies change orders items. Oversees issues and facilitates issues resolution, and escalates, when needed. Identify risks, mitigation, maintenance and resolution. Ensures training required internally and by sponsor is completed. Supports contract team with contracts (SOW, WO, COs, etc.) by developing the budgets and scope of work. Provides performance feedback for project team and managers. Supports business development activities (RFPs and RFIs) and governance activities, when required. Performs other tasks as assigned by Sr. PM staff. Skills and Qualifications: Requires a bachelor’s degree or higher in life sciences. MBA or PMP is preferred. Three plus years of experience in Pharma/CRO industry with 3+ Years’ experience in Project Management. Possesses solid knowledge of Biometrics services and inter-dependencies. Knowledge of FDA regulations, drug development and PM processes. Good understanding of ICH/GCP guidelines. Strong communication s
Role overview
Job description
This is an exciting opportunity to participate in advancing Natera’s oncology product portfolio of cutting-edge diagnostic tests. As Manager of Statistical Programming, you will leverage your strong R programming skills and clinical trials background to contribute to the analysis and reporting of clinical trials supporting multiple regulatory submissions. Primary Responsibilities: Lead and oversee statistical programming deliverables, including ADS (Analysis Datasets) and TLF (Table, Listings and Figures), ensuring data integrity and regulatory compliance with ICH, GCP, and FDA 21 CFR Part 11. May manage a team of statistical programmers, taking responsibility for their technical and professional development, while contributing hands-on to programming work. Act as primary programming lead for regulatory submissions (e.g., 510(k), CTA/CDx, and PMA), ensuring all deliverables meet rigorous
…What they are looking for
Skills & requirements
Qualification
Bachelor’s in Statistics, Mathematics, Computer Science, or a related field. 5+ years of related experience, with at least 3 years of experience in Clinical Trial analysis. At least 3 years of R programming experience, including package development. Knowledge, Skills, and Abilities: Proficient in R programming, including building and maintaining packages. Experience in analysis dataset and TLF generation. Prior experience in NGS, genetics, and/or oncology diagnostics preferred. Experience maintaining statistical computing environments a plus. The pay range is listed and actual compensation packages are based on a wide array of factors unique to each candidate, including but not limited to skill set, years & depth of experience, certifications and specific office location. This may differ in other locations due to cost of labor considerations. Remote USA $132,000 — $165,350 USD OUR OPPORTUNITY Natera™ is a global leader in cell-free DNA (cfDNA) testing, dedicated to oncology, women’s health, and organ health. Our aim is to make personalized genetic testing and diagnostics part of the standard of care to protect health and enable earlier and more targeted interventions that lead to l
Department · Molecular Biology Informatics & Statistics
Hiring company
Natera
Dedicated to oncology, women’s health, and organ health. Natera’s cell-free DNA tests help protect health and inform more personalized decisions about care.
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