LFB USA - Director Biostatistics

US-MA-Southborough
Job ID
2017-1290
# of Openings
1
Category
Clinical/Medical
Type
Full Time
Company
LFB USA

Overview

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.

Responsibilities

  • 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.

Qualifications

  • PhD Statistics/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.

 

 

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