Senior Scientist, Biostatistics Full-time

Statistician Position

Our company in the United States and Canada, is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. The difference between potential and achievement lies in the spark that fuels innovation and inventiveness; this is the space where our company has codified its legacy for over a century. Our company's success is backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare.

In BARDS (Biostatistics and Research Decision Sciences), a distinguished department within our company's renowned Research and Development division, quantitative scientists, in partnership with other subject matter experts, apply state-of-the art scientific methodologies and tools to enable the discovery, development, regulatory approval, manufacturing, and marketing of medical drugs and vaccines for the benefit of patients and global human health.

This position is for a statistician who will contribute to early development clinical trials aimed at identifying, developing and validating biomarkers and platforms that can be used to make early go/no go decisions for our company's compounds. This would include working directly and partnering with cross-functional discovery/development teams.

Responsibilities:

• Provides biostatistical support for drug/vaccine projects in Early Clinical Development Statistics.
• Ensures that sound scientific principles and statistical methods are applied to designing and analyzing clinical studies in support of discovery/experimental medicine/clinical pharmacology clinical trials (and possibly worldwide regulatory submissions).
• Interacts with Clinical, Regulatory, Statistical Programming, Data Management and our company's Research Laboratories Scientists in designing and analyzing clinical trials, and in coordinating the statistical activities for clinical drug/vaccine projects.
• Conducts project work and applied research, as needed.

Primary activities:

• Serves as statistical representative on cross-functional teams for the strategic planning and execution for product discovery and development.
• Develops individual protocols and data analysis plans and determines appropriate statistical methodology for data analysis.
• Participates in database design meetings to ensure that the data evaluated are in high quality and satisfy analysis requirements.
• Collaborates with the statistical programming staff, as needed, to ensure that all programs meet analysis requirements, internal standard operating procedures, and external regulatory requirements.
• Analyzes data and interprets results from clinical trials to meet objectives of the study protocol.
• Prepares oral and written reports to effectively communicate results of clinical studies to the project team, management, regulatory agencies, or individual investigators.
• Provides responses to queries relating to study design, analysis and interpretation posed by the scientists, clinical monitors, regulatory agencies and/or other investigators.
• Participates with management in discussions with corresponding scientific personnel at regulatory agencies and with investigators concerning proposed or ongoing studies.
• Participates in research activities for innovative statistical methods and applications in clinical trials for drug development.

Education Minimum Requirement:

• (i) PhD or equivalent degree in statistics/biostatistics, or (ii) a Master's degree in statistics/biostatistics with a minimum of 3 years relevant experience.

Required Experience and Skills:

• Solid knowledge of statistical analysis methodologies and experimental design.
• Solid knowledge of statistical and data processing software e.g. SAS and/or R. Strong oral and written communication skills. Able to function effectively in a team environment.
• Must also demonstrate the ability to learn, be proactive and motivated, and consistently focus on details and execution.
• Ability to collaborate with scientists and work on multi-discipline teams.
• Demonstrate interest in statistical research activities and in application of novel methods for clinical trials.

Preferred Experience and Skills:

• Strong project management and multi-tasking skills.

Required Skills:

Biostatistics, Business Decisions, Clinical Trials, Clinical Trials Analysis, Data Management, Data Science, Global Health, Manufacturing, Numerical Analysis, Regulatory Compliance, Regulatory Requirements, Scientific Modeling, Statistical Analysis, Statistical Programming, Strategic Management, Strategic Planning

Preferred Skills:

The salary range for this role is $117,000.00 – $184,200.00. This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employee's position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs.

The successful candidate will be eligible for annual bonus and long-term incentive, if applicable.

We offer a comprehensive package of benefits. Available 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. More information about benefits is available at https://jobs.merck.com/us/en/compensation-and-benefits.