The Director of Biostatistics provides strategic input and leadership from a Biostatistics and Data Management perspective in a cross-functional project team environment, ensuring that Biometry accountabilities are delivered and supported.
Identify departmental strategic needs and represent Biometry in high level meetings and discussion.
Ability to supervise Biometry resource allocation, monitor budgets, lead recruitment efforts, and manage internal and cross-functional relationships.
Provide Biometry leadership to support clinical development plans, propose innovative statistical design, randomization, analysis, sample size, and power calculation.
Ensure delivery of key statistical deliverables to include statistical elements in protocol development and clinical study report (CSR), statistical analysis plans (SAPs) and TLFs, data analysis, and statistical result interpretation.
Ensure good Biometry collaboration during the execution of key data management activities to include CRF development, database build, data review and reconciliation, and database lock activities.
Lead preparation of integrated summaries of safety/efficacy (ISS/ISE)and statistical related sections of regulatory submission packages (e.g., eCTD M2.5, M2.7 and M5 for NDAs/BLAs/MAAs), including INDs and EMA variation submissions.
Lead Biometric support for the review and development of regulatory documents such as briefing book, and regulatory interactions as required.
Provide strategic input and direction in the oversight of vendors that conduct statistical work, including the production and QC the statistical deliverables, ensuring accuracy, consistency, and quality output.
Ensure good Biometry collaboration during dry-runs to QC key efficacy and safety data and resolve identified data and programming issues.
Lead Biometry activities in support of interim analysis, DMC activities, adhoc analysis, and publication work.
Spearhead the development and revision of statistics SOPs and process improvement.
PhDStatistics/Biostatistics or related field with at least 10 years clinical trials experience in Biopharma/CRO and at least 5 years of people management.
Proven leadership ability
Excellent knowledge of drug/biologics development process and thorough knowledge of regulatory guidelines to include GCP and ICH guidelines.
Excellent knowledge of therapeutic-specific guidelines related to Biometry work.
Good statistical programming skills with SAS and/or R and experience with statistical software such as EAST and nQuery.
Familiarity with CDISC requirements for SDTM and ADaM.
Demonstrated IND/NDA/BLA/MAA experience.
Excellent communication, presentation, and report writing skills with the ability to explain complex statistical technical details in simple language.
Excellent project management skills, demonstrated leadership, and ability to monitor/oversee multiple projects simultaneously.
Professional attitude, team-oriented, and ability to work independently.