The Associate Director of Biostatistics provides strategic input and leadership from a Biostatistics perspective in a cross-functional project team environment, supporting all statistical aspects for assigned projects.
Serve as lead biostatistician to support clinical development plans, propose innovative statistical design, randomization, analysis, sample size, and power calculation.
Responsible for statistical elements in protocol development and clinical study report (CSR), statistical analysis plans (SAPs) and TLFs, data analysis, and statistical result interpretation.
Support key data management activities to include CRF development, database build, data review and reconciliation, and database lock activities.
Help prepare 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.
Support review and development of regulatory documents such as briefing book, and regulatory interactions as required.
Oversee vendors that conduct statistical work, including the production and QC of the statistical deliverables, ensuring accuracy, consistency, and quality output.
Work closely with the Statistical Programmer and Data Manager during dry-runs to QC key efficacy and safety data and resolve identified data and programming issues.
Support interim analysis, DMC activities, adhoc analysis, and publication work.
Contribute to the development and revision of statistics SOPs and process improvement.
MS in Statistics/Biostatistics or related field with at least 8 years clinical trials experience in Biopharma/CRO or PhD Statistics/Biostatistics or related field with at least 5 years clinical trials experience in Biopharma/CRO.
Excellent knowledge of drug/biologics development process and familiarity with regulatory guidelines to include GCP and ICH guidelines.
Strong 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.
IND/NDA/BLA/MAA experience desired.
Excellent communication, presentation, and report writing skill, and ability to explain complex statistical technical details in simple language.
Good project management skills, attention to details, and ability to work on multiple projects simultaneously.
Professional attitude, team-oriented, and ability to work independently.
Revo Biologics, Inc.