Responsibilities:
- Develop, coordinate, and provide biostatistical support for drug/vaccine projects under supervision in Late Development Statistics.
- Collaborate with Clinical, Regulatory, Statistical Programming, Data Management, and other R&D scientists to design and analyze clinical trials and coordinate statistical activities.
- May initially work in a specific disease therapeutic area.
Primary Activities:
- Serve as statistical representative in cross-functional teams for clinical trial planning, execution, and reporting.
- Develop protocols and data analysis plans; determine appropriate statistical methodology.
- Participate in database design meetings; collaborate with programming staff to meet analysis requirements, internal SOPs, and external regulatory requirements.
- Evaluate software for planned analyses; identify needs for novel methodology development.
- Analyze and interpret clinical trial data to meet protocol objectives; apply basic and complex statistical techniques.
- Prepare oral/written reports; respond to study design/analysis/interpretation queries from monitors, regulators, and investigators.
- Plan and ensure accuracy of Statistical Review Aids submitted to regulators.
- Participate in discussions with regulatory agencies and investigators; contribute to innovative statistical method research.
Education/Minimum Requirement:
- PhD (or equivalent) in statistics/biostatistics or related discipline, or a Masterβs with 3+ years relevant experience.
Required Skills:
- Statistical analysis methodologies and experimental design; SAS and/or R; strong oral/written communication; ability to learn, be proactive, and detail-focused; interest in statistical research and applying novel methods.
Preferred Skills:
- Understanding of biology of disease and drug discovery/development.
Application:
- Apply via https://jobs.merck.com/us/en (or Workday Jobs Hub). Deadline is stated on the posting.
Benefits (if applicable per posting):
- Annual bonus and long-term incentive; comprehensive benefits including medical/dental/vision, retirement (401(k)), paid holidays, vacation, and sick/compassionate days.