Associate Director, Biostatistics Consultant
Parexel
full-time
Posted on:
Location Type: Remote
Location: United States
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Job Level
Tech Stack
About the role
- Provide broad statistical support, including trial design, protocol development, and CRF development for assigned studies
- Lead production and quality control of randomization schedules, statistical analysis plans, statistical reports, statistical sections of integrated clinical reports, and other supporting documentation
- Perform sample-size calculations, generate randomization lists, and write statistical methodology sections for study protocols
- Provide statistical input into Data Monitoring Committee (DMC) activities, including development of DMC charters and statistical analysis plans
- Interact with clients and regulatory authorities
- Review publications and clinical study reports
Requirements
- PhD or MS in Statistics or related discipline with substantial experience
- Prior experience with SAS programming required
- Thorough understanding of statistical issues in clinical trials
- Ability to clearly describe advanced statistical techniques and interpret results
- Familiarity with regulatory and research guidelines on drug development, GCP, and statistical principles (especially ICH guidelines)
- Strong mentoring and leadership skills
- Competent in written and oral English, in addition to local language
Benefits
- Health insurance
- Retirement plans
- Paid time off
- Flexible work arrangements
- Professional development
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
statistical analysistrial designprotocol developmentsample-size calculationsrandomization schedulesSAS programmingstatistical methodologystatistical reportsstatistical sectionsstatistical principles
Soft Skills
mentoringleadershipcommunicationinterpersonal skills
Certifications
PhD in StatisticsMS in Statistics