Parexel · 19 hours ago
Associate Director, Biostatistics Consultant
United States
Full-time
Remote
Lead/Staff, Director/ExecutiveParexel is a leading global biopharmaceutical services organization, and they are seeking a Principal Biostatistician with a focus on Patient-Reported Outcomes. The role involves providing statistical support for clinical trial projects, leading operational execution, and contributing to business development activities.
Pharmaceuticals
Responsibilities
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
Serve in a supporting role as a non‑voting independent statistician, preparing data and analyses for DMC review
Support Business Development activities by contributing to study design discussions during internal and client meetings
Provide and explain sample‑size scenarios
Support proposal and budget development
Attend and prepare for bid defense meetings
Understand regulatory requirements across therapeutic areas and their implications for statistical methods, processing, and analysis
Understand, apply, and provide training in extremely advanced and emerging statistical methods
Contribute to the development and delivery of internal and external statistical training seminars and courses
Review position papers in accordance with current good statistical practice
Interact with clients and regulatory authorities
Review publications and clinical study reports
Travel to and actively contribute in client meetings (e.g., discussing analysis concepts or presenting study results)
Perform additional responsibilities as defined by supervisor or manager
Qualification
Required
PhD or MS in Statistics or related discipline with substantial experience
Strong analytical skills
Strong project management skills
Professional attitude with excellent attention to detail
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)
Prior experience with SAS programming required
Ability to work independently
Strong mentoring and leadership skills
Strong business awareness and business development aptitude
Preferred
Knowledge of pharmacokinetic data is an advantage
Competent in written and oral English, in addition to local language
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
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