$4,000,000 Per Year
$8,000,000 Per Year
Provides strategic statistical leadership across all clinical development programs. Leads a team of statisticians and statistical programmers for clinical submissions. Develops and reviews statistical analysis plans and adaptive trial designs. Represents statistics function in regulatory agency scientific discussions. Oversees NDA, BLA, and ANDA submission statistical packages for approval. Provides statistical expertise for portfolio decisions and clinical strategy. Develops statistical methodology and standards for clinical development. Manages CRO biostatistics oversight and statistical quality programs. Supports preparation of responses to FDA statistical review questions. Mentors and develops team members in statistical science and programming. Provides statistical input for complex innovative trial design programs. Collaborates with clinical, regulatory, and medical affairs leadership teams. Stays current with ICH E9, E17, and FDA statistical methodology guidance.