Validation Engineer / Commissioning Engineer

Validation Engineer / Commissioning Engineer

Job Code: SANNEE0909
Date: 01-01-1970
Job Description :

Job 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

Job Tags: SAAS
Job Location: Framingham, MA