Principal Biostatistician

🔥 13 hours ago

🏄 California – Remote

🏄 California – Remote

💵 $132k - $186k / year

⏰ Full Time

🔴 Lead

🧪 Clinical Research

🦅 H1B Visa Sponsor

This company has sponsored H1B visas in the past.

👻 Ghost score 0%

What it means: how likely this posting is sitting open without active hiring.How to read it: 60% or higher means we think this is a ghost. Lower scores are less of a worry.How we score it: age, reposts, open roles vs team size, how fast jobs close, and whether pay is listed.Fine print: an estimate from public data, not a judgment of the company. Real jobs can score high, so treat it as a hint, not a fact.

Apply Now

Find Similar Remote Jobs

Set Up Email Alert For New Jobs

📊 Check your resume score for this job

Improve your chances of getting an interview by checking your resume score before you apply.

Upload Resume

Edwards Lifesciences

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1958

🏥 Healthcare

💼 Consulting

🍽️ Food & Beverage

Healthcare • Consulting • Food & Beverage

Edwards Lifesciences is a global leader in patient-focused medical innovations. The company specializes in heart valve disease solutions, offering products and services such as transcatheter heart valves and mitral and tricuspid technologies, as well as surgical heart valve solutions. Edwards Lifesciences also focuses on critical care technologies including hemodynamic monitoring, remote monitoring, and predictive monitoring. The company conducts clinical research and is committed to improving patient lives through innovative cardiovascular disease solutions, while being a responsible corporate citizen with an emphasis on global corporate giving.

📋 Description

• Serve as statistical lead on multiple clinical trials • Lead coordination of analyses for study reports and other documents • Provide programming and validation support for analyses • Collaborate with stakeholders on new product development and regulatory submissions, including PMA, CE Mark, and PMDA • Represent Biostatistics on project and study teams • Communicate project and study status and timeline updates to management and team members • Research and recommend novel statistical methodologies and approaches • Provide statistical expertise for ad hoc data analysis requests and publication/presentation efforts • Compile technical documents for internal and external audits • Improve, standardize, and globalize Biostatistics processes and procedures • Develop Biostatistics Standard Operating Procedures and Work Instruction Manuals • Lead data analysis efforts for data monitoring committees as needed • Mentor junior statisticians • Support resource allocation and budget/timeline development activities

🎯 Requirements

• Ph.D. or equivalent in Statistics, Biostatistics, or related field, with 2 years’ experience • Master's Degree or equivalent in Statistics, Biostatistics, or related field, with 5 years’ previous analytical experience in clinical trials • Proven expertise in R • Experience with additional statistical software packages, such as S-PLUS or other analytics tools • Experience with CDISC standards, including SDTM and ADaM • Expertise in clinical trial data structures, data standardization, and regulatory-compliant statistical analysis • Proven expertise in MS Office Suite, including Word, PowerPoint, Access, and Excel • Excellent written and verbal communication and interpersonal relationship skills • Ability to negotiate, manage relationships, and drive achievement of objectives • Knowledge of new developments in statistics and regulatory guidance • Expert knowledge of statistical methodologies related to clinical trial designs, statistical modeling, and data analyses • Expert knowledge of regulatory guidelines, including GCP, ICH, FDA, and ISO, relevant to pharmaceutical/medical device industries • Excellent problem-solving, organizational, analytical, and critical-thinking skills • Strong leadership skills and ability to influence change • Ability to provide training and coaching to lower-level employees • Experience facilitating change and collaborating with management and executive stakeholders

🏖️ Benefits

• Competitive salaries • Performance-based incentives • Wide variety of benefits programs addressing the diverse individual needs of employees and their families