Precision For Medicine
1001 - 5000 employees
🏥 Healthcare
đź’Ľ Consulting
📦 Logistics
đź’° $75M Private Equity Round on 2015-12
Healthcare • Consulting • Logistics
Precision For Medicine is a leading organization that specializes in supporting the development and commercialization of innovative therapies, particularly in oncology, rare diseases, and autoimmune conditions. With a comprehensive range of services including clinical trial management, lab services, and biospecimen collection, they integrate advanced biomarker capabilities and manufacturing solutions to streamline the complex clinical development processes. Their mission is to accelerate research and bring life-changing medical solutions to patients by overcoming traditional inefficiencies typically found in the pharmaceutical development landscape.
Principal Biostatistician/Senior Principal Biostatistician
Job not on LinkedIn
🔥 4 minutes ago
đź“Š Check your resume score for this job
Improve your chances of getting an interview by checking your resume score before you apply.
Precision For Medicine
1001 - 5000 employees
🏥 Healthcare
đź’Ľ Consulting
📦 Logistics
đź’° $75M Private Equity Round on 2015-12
Healthcare • Consulting • Logistics
Precision For Medicine is a leading organization that specializes in supporting the development and commercialization of innovative therapies, particularly in oncology, rare diseases, and autoimmune conditions. With a comprehensive range of services including clinical trial management, lab services, and biospecimen collection, they integrate advanced biomarker capabilities and manufacturing solutions to streamline the complex clinical development processes. Their mission is to accelerate research and bring life-changing medical solutions to patients by overcoming traditional inefficiencies typically found in the pharmaceutical development landscape.
đź“‹ Description
• Provides statistical leadership and support for all phases of clinical development • Specific responsibilities include consulting with clients regarding clinical trial study design and regulatory strategy • Writing and reviewing statistical methods and sample size sections of protocols • Writing and reviewing statistical analysis plans of complex study designs • Reviewing statistical analyses and presenting statistical results • Lead complex programs such as NDA/BLA/MAA submissions or complex, multi-protocol programs and provide statistical oversight • Serve as a subject matter expert for one or more areas (e.g., Bayesian adaptive study design, Survival analysis, DMC, submissions)
🎯 Requirements
• Senior Principal Biostatistician level: Master's degree or equivalent in Statistics, Biostatistics, or related field with 12+ years of experience; PhD degree in Statistics, Biostatistics, or related field with 9+ years of experience • Principal Biostatistician level: Master's degree or equivalent in Statistics, Biostatistics, or related field with 10+ years experience; PhD degree in Statistics, Biostatistics, or related field with 7+ years experience • Broad experience with regulatory submissions • Extensive experience consulting with clients regarding clinical trial study design and regulatory strategy • Superior understanding of a statistical methodology (e.g., Bayesian adaptive study design, Survival analysis, Repeated measures) • Sound knowledge of industry standards such as the ICH guidelines, CDISC data structures, 21 CFR Part 11, and FDA guidelines • Experience with SAS
🏖️ Benefits
• discretionary annual bonus • health insurance • retirement savings benefits • life insurance • disability benefits • parental leave • paid time off for sick leave and vacation
Apply NowSimilar Jobs
đź•’ July 18
Senior Project Specialist supporting global clinical trials within a sponsor-dedicated environment at Syneos Health. Focused on Trial Master File management and project coordination.
🗣️🇫🇷 French Required
đź•’ July 11
Clinical Trial Manager II overseeing clinical trials in dermatology and rheumatology at Indero. Managing clinical monitoring deliverables and ensuring quality in clinical research operations.
🗣️🇫🇷 French Required
đź•’ June 26
Senior Biostatistician at Everest Clinical Research providing statistical expertise for clinical trials. Leading statistical planning, analysis, and reporting for various research projects.
đź•’ April 15
Clinical Trial Manager at Syneos Health, responsible for site management oversight and clinical monitoring in drug development. Leads project milestones and ensures compliance with protocols and regulations.
đź•’ March 10
Clinical Trial Manager overseeing site management and monitoring deliverables at Syneos Health. Focused on patient safety and protocol compliance in clinical trials.
