VP, Biostatistics

Job not on LinkedIn

🔥 0 minutes ago

🍂 Massachusetts – Remote

🍂 Massachusetts – Remote

⏰ Full Time

🔴 Lead

👔 Vice President

👻 Ghost score 10%

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.

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BioCryst Pharmaceuticals, Inc.

WebsiteLinkedInAll Job Openings

501 - 1000 employees

🏥 Healthcare

💼 Consulting

📦 Logistics

💰 $450M Post-IPO Debt - BioCryst Pharmaceuticals on 2023-04

Healthcare • Consulting • Logistics

BioCryst Pharmaceuticals, Inc. is a global biotechnology company focused on the discovery, development, and commercialization of novel oral small-molecule and protein therapeutics for rare diseases, notably hereditary angioedema (HAE). Founded in 1986, BioCryst uses structure-guided drug design, medicinal chemistry, and advanced technologies to develop first-in-class or best-in-class medicines, and works closely with patients, advocacy groups, and global partners to bring treatments to market.

📋 Description

• Ensure relevance, adequacy and accuracy of state-of-the-art statistical methods in BioCryst-sponsored clinical development activities and selected nonclinical studies • Oversee statistical activities for regulatory submissions, including NDA/BLAs • Ensure clinical data processing conforms to regulatory guidelines and Good Clinical Practice • Contribute to clinical development strategies, including development program and study design • Lead and manage junior biostatistics staff • Select, direct and supervise CRO and contract staff performing outsourced operational activities • Use SAS, EAST and R for ad hoc data analyses and sample-size work • Participate in clinical development and product management teams • Represent the company on biostatistical topics at FDA and other regulatory agency meetings • Define, create and implement organization-wide processes focused on efficiency and productivity • Define, monitor and evaluate relevant performance metrics • Author and review critical product-development documents, including protocols, statistical analysis plans, data management plans, regulatory briefing documents, NDAs, MAAs, regulatory responses, abstracts and manuscripts • Ensure accuracy of clinical-trial data in public corporate communications and monitor their quality-audit process • Communicate technical concepts rigorously to technical, regulatory and nontechnical audiences

🎯 Requirements

• Ph.D. in Biostatistics or related field with at least 18 years’ experience in the pharmaceutical industry, 10 or more years’ experience in the design, analysis and interpretation of clinical trials, or an equivalent combination of education and experience • At least 5 years of people management and leadership experience • Knowledge and expertise in modern adaptive clinical trial designs, multiplicity testing methods, real world evidence and quantitative decision making • NDA/BLA filing experience and key contributor experience to multiple successful product approvals • Proven expertise with biostatistics disciplines, practices and procedures, including development and accountability for relevant quality management systems • Experience with Data Monitoring Committees and/or study steering committees • Hands-on approach, including performing analyses when necessary • Excellent written and verbal communication skills • Ability to work well in a collegial environment and willingness to challenge the status quo • Experience with global regulatory agencies • Formal expertise and experience in Bayesian and frequentist statistics • Ability to embrace change within a high-risk environment

🏖️ Benefits

• Equal employment opportunities without regard to age, race, religion, sex, sexual orientation, gender identity, national origin, Veterans status, disability and/or other protected class characteristics • Compliance with all federal, state and local law