under some supervision to solve complex study problems. Qualifications: - Master's Degree in statistics or biostatistics required - PhD... in statistics or biostatistics preferred Experience Qualifications - 8+ Years of relevant experience in the pharmaceutical industry...
and immune disorders. Summary The Associate Director of Regulatory Writing is a key role responsible for producing... at the study team level. The Associate Director of Regulatory Writing must possess advanced knowledge of BLA/MAA submissions...
to Clinical Operations, Clinical Development, Biostatistics and Data Management, Regulatory Affairs, Quantitative Clinical...
issues to the Associate Director of Medical Coding to gain resolution. Functional Expertise: Study Start-Up: Reviews... and Biostatistics program teams to meet needs of the study and/or program. Participates in audits and inspections to provide study...