Radius Health, Inc.

Director, Biostatistics

Job Locations US-MA-Waltham
Posted Date 3 weeks ago(1/31/2018 11:57 AM)
Job ID
2018-1683
# of Openings
1
Category
Biometrics

Overview

The Associate Director or Director, Biostatistics will be responsible for all statistical activities of assigned clinical studies. The incumbent will be the statistical lead and point-of-contact on statistical activities for the clinical study teams.

Responsibilities

  • Plan, manage, and perform statistical tasks to support clinical trials, publications and regulatory submissions
  • Apply and ensure statistical approaches complying with regulatory guidelines to study design, analysis and data exploration methodologies, including adaptive methods to dose finding
  • Represent Biostatistics on the assigned study teams and serve as the statistical contact for the clinical studies
  • Participate in vendor selection and oversee statistical activities performed by vendors
  • Provide statistical support to the planning, authoring, and review of manuscripts, publications and other scientific data disclosures
  • Contribute to regulatory document preparations, including meeting briefing package, integrated analysis reports, and CTD summaries
  • Collaborate with internal and/or external team members to plan and execute biostatistical deliverables supporting the clinical studies
  • Contribute to the establishment, maintenance and improvement of department/company processes and procedures
  • Assist in the standardization and development of best practices to improve quality, efficiency and effectiveness of the department/company

Qualifications

  • MS in Biostatistics, Statistics, Epidemiology, or Mathematics with at least 7 years of pharmaceutical experience; or PhD or DrPH in Biostatistics, Statistics, Epidemiology, or Mathematics with at least 4 years of pharmaceutical experience
  • Oncology experience preferred
  • Strong technical abilities and skills in statistical methodologies, with working knowledge of using SAS, R, EAST and other statistical software
  • Extensive knowledge of drug development and regulatory guidance/requirements
  • Effective communication, interpersonal, problem solving and analytical skills
  • Experience in regulatory submissions (eg, NDA/MAA) and regulatory review/approval process

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