Associate Director, Biostatistics - IQVIA Biotech (m/w/d)
Core
Lead biostatistician providing senior-level statistical review, oversight, and leadership for clinical programs in oncology, CNS, immunology, and cardiovascular therapy areas.
Role type
Senior IC biostatistician with people leadership responsibilities
Builds
Statistical Analysis Plans (SAPs), ADaM specifications, datasets, Tables/Lists/Figures (TLFs), and clinical study reports
Domain
Biotech and emerging biopharma clinical development
Required skills
Oncology drug development expertise, advanced statistical methodologies, SAS Base/Stat, N-Query/S-Plus, regulatory submission support, bid defense leadership, team mentoring, client relationship management
Preferred skills
Experience with Phase I-IV trials, GCP/ICH/FDA guidelines, training material development
Technologies
SAS Base, SAS Stat, N-Query, S-Plus
Responsibilities
Provide statistical consultation for protocol development, randomization, sample size, and efficacy evaluations; Review and approve SAPs and TLFs; Mentor and develop biostatistical staff across global regions; Lead bid defense meetings and coach future team leads; Interface with clients and regulatory agencies; Oversee program of studies and ensure project timelines
Seniority
Senior, hands-on IC with people leadership