Remote- US | Full‑Time

About the Role

The Principal Biostatistician works independently across clinical trial projects of all complexity levels, including those with major regulatory impact. This position is highly visible within the organization and to external partners and is recognized as a statistical expert. The ideal candidate is a strong communicator, trusted advisor, and technical leader capable of driving statistical strategy and execution across multiple therapeutic areas.

Key Accountabilities

Operational Execution

• 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
• This position is focusing on Patient-Report Outcomes (PRO)

Business Development

• 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

General Activities

• 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

Skills

• 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

Knowledge & Experience

• PhD or MS in Statistics or related discipline with substantial experience
• Knowledge of pharmacokinetic data is an advantage
• Competent in written and oral English, in addition to local language

Education

• PhD in Statistics or related discipline, or
• MS in Statistics or related discipline