Parexel · 2 weeks ago
Principal Biostatistician
United States
Full-time
Remote
Lead/StaffParexel is hiring a Principal Biostatistician to work remotely. The Principal Biostatistician will work independently on complex clinical trial projects and is recognized as a statistical expert, providing broad statistical support and contributing to business development efforts.
Pharmaceuticals
Responsibilities
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
Travel to, attend, and actively contribute to all kind of client meetings as appropriate (e.g. discussing analysis concepts, presenting and discussing study results)
Additional responsibilities as defined by supervisor/manager
Qualification
Required
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
Travel to, attend, and actively contribute to all kind of client meetings as appropriate (e.g. discussing analysis concepts, presenting and discussing study results)
Additional responsibilities as defined by supervisor/manager
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
PhD or MS in Statistics or related discipline with substantial experience
Competent in written and oral English in addition to local language
PhD in Statistics or related discipline, MS in Statistics or related discipline
Preferred
The knowledge of pharmacokinetic data is an advantage
Company
Parexel
Parexel is a leading global clinical research organization (CRO) providing insights-driven Clinical and Consulting solutions to the world’s life sciences industry.
Founded in 1983
10001+ employees
H1B Sponsorship
Parexel has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (33)
2024 (46)
2023 (41)
2022 (51)
2021 (54)
2020 (33)
Funding
Current Stage
Late StageLeadership Team
Amy France
SVP, CFO - Consulting & Commercial
Carlos Daniel Garcia
VP Chief Financial Officer - Medical Scientific Services Business Unit
Recent News
2024-04-27
2024-04-07
Company data provided by crunchbase