Responsibilities:
- 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 (discovery/experimental medicine/clinical pharmacology), including potential regulatory submissions.
- Partner with Clinical, Regulatory, Statistical Programming, Data Management, and Research Laboratories scientists on trial design/analysis and coordinate statistical activities.
- Conduct project work and applied research as needed.
Primary Activities:
- Serve as statistical representative on cross-functional teams for discovery/development planning and execution.
- Develop protocols and data analysis plans; determine appropriate statistical methodology.
- Participate in database design meetings to ensure data quality and analysis fit.
- Collaborate with statistical programming to ensure programs meet requirements (internal SOPs and external regulatory).
- Analyze trial data, interpret results, and meet protocol objectives.
- Prepare oral and written reports for project teams, management, regulators, and investigators.
- Respond to study design/analysis/interpretation queries from scientists/monitors/regulators.
- Participate in discussions with regulatory agencies and investigators.
- Contribute to innovative statistical methods/applications for clinical trials.
Education Minimum:
- PhD (or equivalent) in statistics/biostatistics; or Masterβs in statistics/biostatistics with 3+ years relevant experience.
Required Skills/Experience:
- Solid statistical analysis methodology and experimental design knowledge.
- Proficiency with SAS and/or R; strong oral/written communication; effective teamwork.
- Proactive, detail-focused, motivated; collaborative multi-discipline work.
- Interest in statistical research and novel clinical trial methods.
Preferred:
- Strong project management and multi-tasking skills.
Application:
- Apply via https://jobs.merck.com/us/en (or Workday Jobs Hub). Apply by the deadline shown on the posting.