Seeking a highly skilled Statistics Methodology Expert to join the Biometry Department to strengthen methodological excellence, scientific quality and regulatory robustness in clinical trials and Real-World Evidence studies.
Compensation
Incentives, profit-sharing, Pierre Fabre shareholding with matching contribution, health and provident insurance, 16 days of holidays (RTT) in addition to 25 days of personal holidays, public transport participation
Responsibilities
Provide expert methodological support for clinical trials and Real-World Evidence studies across all phases of drug development
Advise statisticians on advanced, innovative or complex statistical methods
Support statistical strategy and methodological discussions during interactions with health authorities
Promote consistent and scientifically robust statistical approaches across studies and therapeutic areas
Assess the statistical robustness of investigator-initiated interventional and non-interventional studies
Requirements
Advanced degree in Statistics, Biostatistics or a related field (Master's Degree or PhD)
Infection Prevention Epidemiologist promoting high-quality patient care through scientific infection prevention and epidemiology principles within Children’s Healthcare of Atlanta.
Responsibilities
Surveils Health-Acquired Infections and epidemiologically significant community-acquired infections
Communicates and intervenes actively with healthcare workers regarding infection prevention and epidemiology processes
Interprets and reports data using statistical methodology
Completes accurate reporting to regulatory agencies
Develops emergency preparedness and disaster planning/response to infectious events
Requirements
Bachelor’s degree in an applied science (biology or chemistry), nursing, public health, epidemiology, clinical laboratory science, medical technology, health promotion, pharmacy or related field
Nice to have: clinical experience in a pediatric hospital or critical care setting
Nice to have: Master’s degree in an applied science (biology or chemistry), nursing, public health, epidemiology, clinical laboratory science, medical technology, health promotion, pharmacy or related field
Nice to have: certification in Infection Prevention and Control (CIC) or Certified in Public Health (CPH)
Nice to have: current GA license in applicable health profession
Lead biostatistical analysis for global clinical trials in a biotechnology setting, overseeing study design, protocol writing, analysis, and reporting.
Responsibilities
Implement diverse statistical tasks throughout the full clinical trial process
Develop and review statistical analysis plans
Conduct benefit-risk analysis and safety reporting (DSUR, PSUR)
Manage multiple clinical trials simultaneously
Apply CDISC standards and statistical software (SAS, R, EAST, WinBUGS)
Requirements
Advanced Degree in Statistics, Biostatistics, or related quantitative field
Nice to have: Experience in CRO environment
Nice to have: Vendor management
Nice to have: Auto-immune and/or oncology therapeutic areas
Lead the biostatistics strategy for the NKX019 autoimmune program and serve as statistician of record across all indications, studies and health-authority interactions.
Compensation
$300,000—$360,000 USD
Responsibilities
Lead the biostatistics strategy for the NKX019 autoimmune program
Author and own statistical analysis plans (SAPs) and amendments
Independently perform complex analyses
Design potential pivotal studies, including power and sample-size justification
Translate the evolving Phase 1/2 dataset into the quantitative case for indication, dose and development decisions
Requirements
PhD in Biostatistics or Statistics
Nice to have: cell or gene therapy
Nice to have: B cell-directed therapies
Nice to have: patient-reported outcome instrument development
Lead and mentor a team of biostatisticians in rare disease clinical development, providing statistical expertise, regulatory submissions, and strategic guidance.
Responsibilities
Lead and mentor biostatisticians
Provide strategic support to asset teams
Author and review study documents (protocol, SAP, dataset specifications, clinical study report, publications, regulatory submissions)
Coordinate planning and execution of biostatistics deliverables
Ensure quality, accuracy, and adherence to timelines
Requirements
MS in statistics or biostatistics (required)
PhD in statistics or biostatistics (preferred)
Nice to have: Rare disease drug development experience
Nice to have: Regulatory submission experience (US FDA, EMA, PMDA)
The Quality Engineer I will be part of a collaborative technical team responsible for investigating product complaints and ensuring the quality and performance of cardiac ablation technologies.
Compensation
Salary ranges for U.S (excl. PR) locations (USD):$66,400.00 - $99,600.00
Responsibilities
Perform complaint investigations for Cardiac Ablation Solutions products.
Conduct analysis and testing of returned products to help identify potential product issues.
Partner with engineering teams to identify and elevate risk-file signals when appropriate.
Support the development and improvement of procedures, processes, tools, and techniques used for product analysis.
Develop and implement methods and procedures for the inspection and testing of returned products.
Requirements
Bachelor's degree in Engineering, Physics, or a related degree program
Performs scientific investigative research in biomedical areas related to patient care, including bioinformatic, phylogenetic and statistical methodology analysis.
Responsibilities
Conducts experiments and analyses according to established protocols and research methodology
Develops new experimental protocols to carry out established research objectives
Participates in the design of research protocols to achieve the scientific objectives to allow quantitative and qualitative evaluation and interpretation of data obtained
Collects and analyzes data using bioinformatic, phylogenetic and statistical methodologies and software
Participates in the interpretation of the results through conferences with supervisors and other researchers
Requirements
PhD
MD
Nice to have: cardiovascular and cardiopulmonary pathobiology
Assistant Professor - Statistics (AI & Drug Discovery)USF University of South Florida · Tampa, US
Senior Director/Executive Director, BiostatisticsNkarta, Inc. · South San Francisco, US