Senior Biostatistician Consultant
Parexel
full-time
Posted on:
Location Type: Remote
Location: Argentina
Visit company websiteExplore more
Job Level
Tech Stack
About the role
- Good analytical skills.
- Good project management skills.
- Professional attitude.
- Attention to detail.
- Thorough understanding of statistical issues in clinical trials.
- Ability to clearly describe advanced statistical techniques and interpret results.
- Familiarity with regulatory/research guidelines on drug development, GCP, and statistical principles (especially ICH guidelines).
- Prior experience with SAS programming required.
- Ability to work independently.
- Good mentoring/leadership skills.
- Good business awareness/ business development.
Requirements
- PhD or MS in Statistics or related discipline with substantial experience.
- The knowledge of pharmacokinetic data is an advantage.
- Competent in written and oral English in addition to local language.
Benefits
- The Principal Biostatistician works independently on all level complexity clinical trial projects, often with major regulatory impact.
- Provide broad statistical support, including trial design, protocol and CRF development on specific studies.
- Lead production and quality control of randomization, analysis plans, statistical reports, statistical sections of integrated clinical reports and other process supporting documents.
- Perform sample-size calculations, generate randomization lists and write statistical methodology sections for inclusion in study protocols.
- Provide statistical input into Data Monitoring Committee (DMC) activities, including development of DMC charters and analysis plans.
- Provide a supporting role as a non-voting independent statistician providing data and analysis for DMC review.
- Support of Business Development, by actively contributing to study design considerations in internal and client meetings, providing and discussing sample size scenarios, support of budget and proposal development, attending and preparing bid defense meetings.
- Understand regulatory requirements related to the specific therapeutic areas and the implications for statistical processing and analysis.
- Understand, apply and provide training in extremely advanced and sometimes novel statistical methods.
- Contribute to the development and delivery of internal and external statistical training seminars and courses.
- Review position papers based on current good statistical practice.
- Interact with clients and regulatory authorities.
- Review publications and clinical study reports.
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
SAS programmingstatistical techniquespharmacokinetic data
Soft Skills
analytical skillsproject management skillsprofessional attitudeattention to detailmentoring skillsleadership skillsbusiness awarenessbusiness development
Certifications
PhD in StatisticsMS in Statistics