MedImmune, LLC
Gaithersburg, Maryland
Feb 03, 2019
Feb 17, 2019
Full Time

Senior Principal Statistician wanted by biotech. co. in Gaithersburg, MD. Provide highly exp'd strategic input, statistical expertise, & leadership to project teams in the dsgn & interpretation of clinical studies & clinical dvlpmt prgms in support of the Global Product Statistician (GPS). Serve as primary author for statistical sections of protocol concept sheets (PCS), protocols, clinical development plans (CDP), & integrated product development plans (iPDP). Perform statistical analyses & create statistical text for clinical publications & other communications. Provide direction & statistical oversight to outsourcing partners/providers regarding reqmts & stndrds for study-level work, holding partners/providers accountable for the qlty of their deliverables. Define & lead analysis of relevant internal & external info to inform dsgn decisions. Provide statistical support & leadership to clinical trial teams (CTT), clinical sub-teams (CST) & product development teams (PDT) on the dvlpmt of Target Product Profile and Target Product Claims (TPP/TPC), Benefit, Risk, Value and Uncertainty (BRV(U)), clinical development plans (CDP), & regulatory strategy. Lead dvlpmt of components of regulatory submissions (eg, briefing docs, response to FDA requests, BLA/NDA, & sBLA/sNDA). Reqs: Ph.D. deg. (or foreign equiv deg.) in Statistics, Biostatics, or Math, & a min. of 2 yrs of industry exp in clinical study envrmt in job offrd or as Biostatistics Mgr. Must have 2 yrs of industry exp (which may have been obtained concurrently): using statistical methods & applics in study dsgn & analysis; writing SAP/protocol/prgmg specs; dvlpg clinical dvlpmt plans, master shell, protocols, statistical analysis plans, & clinical study reports; involved in regulatory interactions & submissions; using statistical s/ware such as nQuery, R, & SAS. Send resumes to MedImmune, LLC, 1 MedImmune Way, Gaithersburg, MD 20878. To apply, go to & search for requisition #: R-042360.