Associate Director Biostatistics

Revo Biologics, Inc. Framingham , MA 01702

Posted 11 months ago

Overview

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.

Responsibilities

  • 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.

Qualifications

  • 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.

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Associate Director Biostatistics

Revo Biologics, Inc.