SENIOR PRINCIPAL STATISTICIAN

Employer
MedImmune, LLC
Location
Gaithersburg, Maryland
Posted
Feb 03, 2019
Closes
Feb 17, 2019
Function
Other
Hours
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 http://www.astrazenecacareers.com & search for requisition #: R-042360.