Senior Scientist, Biostatistics

Job Overview

Our company, a global health care leader in the United States and Canada, is seeking a statistician to contribute to early development clinical trials focused on biomarkers and platforms that inform go/no‑go decisions for our drug and vaccine portfolios. The role involves partnering with cross‑functional discovery and development teams.

• Provide biostatistical support for drug/vaccine projects in Early Clinical Development Statistics.
• Apply sound scientific principles and statistical methods to design and analyze clinical studies supporting discovery, experimental medicine, and clinical pharmacology trials, including regulatory submissions.
• Interact with Clinical, Regulatory, Statistical Programming, Data Management, and Research Laboratory teams to design studies and coordinate statistical activities.
• Conduct project work and applied research as needed.

• Serve as statistical representative on cross‑functional teams for product discovery and development strategy.
• Develop individual protocols, data analysis plans, and determine appropriate statistical methodology.
• Participate in database design meetings to ensure high‑quality data that meet analysis requirements.
• Collaborate with statistical programming staff to ensure programs meet analysis requirements, internal SOPs, and regulatory requirements.
• Analyze data and interpret results from clinical trials to meet study protocol objectives.
• Prepare oral and written reports to communicate results to project teams, management, regulatory agencies, or investigators.
• Respond to queries regarding study design, analysis, and interpretation from scientists, clinical monitors, regulatory agencies, and investigators.
• Participate in discussions with regulatory agencies and investigators concerning proposed or ongoing studies.
• Engage in research activities for innovative statistical methods and applications in drug development trials.

• PhD or equivalent in statistics/biostatistics, or a Master’s degree in statistics/biostatistics with at least 3 years of relevant experience.

• Solid knowledge of statistical analysis methodologies and experimental design.
• Proficiency with statistical and data processing software such as SAS and/or R.
• Strong oral and written communication skills and ability to function effectively in a team environment.
• Demonstrated ability to learn, be proactive, motivated, and consistently focus on detail and execution.
• Ability to collaborate with scientists and work on multi‑disciplinary teams.
• Interest in statistical research activities and application of novel methods for clinical trials.

• Strong project management and multi‑tasking skills.

Salary range: $ – $. The successful candidate will be eligible for annual bonus and long‑term incentive, if applicable.

Benefits include medical, dental, vision, healthcare and other insurance benefits for employee and family, retirement benefits (including 401(k)), paid holidays, vacation, and compassionate and sick days.

As an Equal Employment Opportunity Employer, we provide equal opportunities for all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics. As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities.