Usa biostatistician with sas programming ii clinical - united states, cambridge bay
100% remote
role description
• serve as project lead within global heva and across multiple therapeutic areas to conduct post-hoc analysis of randomized clinical trials in support of market access and reimbursement evidence needs
• scientifically accountable at global and local levels for design and timely execution of post-hoc statistical analyses for hta submissions and pricing/reimbursement negotiations
• support countries for local hta submissions
• provide statistical expertise within heva and with several stakeholders including market access and pricing, medical affairs, clinical outcome assessment team, biostatistics
main responsibilities
• lead, design, conduct and qc post-hoc statistical analyses required for hta submissions and pricing/reimbursement negotiations at global and local levels on a timely manner
• present and explain statistical analyses to team members, internal forum, internal managers and/or external authors and experts
• publication activities: provide consultation, input and guidance to cross-functional groups charged with development and submission of manuscripts, posters, slide presentations and abstracts; work with publication leads and team members to respond in a timely manner to journal editor and reviewer comments
• support clinical teams in the analyses of patient-reported outcomes (pros) and health economic endpoints for phase 2, 3 and 4 studies, by contributing and/or reviewing protocols, statistical analysis plans, clinical study reports, and submission modules
basic qualifications & experience
• msc or phd in statistics, biostatistics or related quantitative sciences
• 3-6 years of experience as a statistician supporting clinical trials, medical affairs or clinical development, including conducting statistical analyses from phase 3 or phase 4 studies, in an industry setting (ie. pharma, biotech, cro)
• saas experience is required
knowledge and skills
• thorough and up-to-date knowledge of statistical methods, especially those related to human clinical studies
• thorough and up-to-date working knowledge of sas with hands-on programming experience. knowledge of s-plus or r is a plus
• working knowledge of sdtm and adam data structure and cdisc standards
• working knowledge of regulatory guidelines for drug development, nda submissions, and statistical practices (ie. ctd guidance, ich guidelines) is a plus
• working knowledge of pros; experience in psychometric assessment is a plus
equal opportunity employer/veterans/disabled
the company will consider qualified applicants with arrest and conviction records
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