Principal Scientist, Biostatistics (Late-Stage Clinical Development)

Location: Hybrid; North Wales, Pennsylvania, or Rahway, New Jersey, United States. Domestic relocation is available. The role is open to United States residents and offers visa sponsorship.

Salary: $190,800–$300,300 per year for the primary location; annual bonus and long-term incentive may also apply.

Company

hirify.global's BARDS organization applies quantitative science and research methodologies to the discovery, development, regulatory approval, manufacturing, and marketing of medicines and vaccines.

What you will do

• Serve as the statistical lead and representative on cross-functional clinical development teams.
• Provide biostatistical leadership for late-stage drug and vaccine projects, including strategic planning and execution.
• Design clinical trials, develop protocols and statistical analysis plans, and determine appropriate methodologies.
• Analyze clinical trial data, interpret results, identify technical problems, and implement solutions.
• Coordinate with Clinical, Regulatory, Statistical Programming, Data Management, research laboratories, AROs, CROs, consultants, investigators, and regulatory agencies.
• Lead or mentor statisticians and statistical programming staff, support regulatory submissions, and contribute to innovative statistical research.

Requirements

• PhD or equivalent in statistics, biostatistics, or a related discipline with at least 6 years of relevant experience, or a Master's degree with at least 9 years of relevant experience.
• Solid knowledge of statistical analysis methodologies and experimental design.
• Strong project management, oral communication, written communication, teamwork, learning, initiative, motivation, attention to detail, and execution skills.
• Knowledge of statistical and data-processing software such as SAS and/or R.
• Understanding of worldwide regulatory requirements and clinical trial expertise from Phase II to Phase V.
• Interest in statistical research and applying novel methods to clinical trial development.

Nice to have

• Publications in peer-reviewed statistical or medical journals.
• Understanding of disease biology and drug discovery and development.

Culture & Benefits

• Hybrid work arrangement.
• Medical, dental, vision, and other insurance benefits for employees and families.
• Retirement benefits, including 401(k).
• Paid holidays, vacation, compassionate leave, and sick days.
• Annual bonus and long-term incentive eligibility, where applicable.
• Inclusive environment that values diverse perspectives and collaborative problem-solving.