• Serves as a statistical lead in project teams
• Lead, develops, coordinates, and provides biostatistical support for related drug/vaccine projects in Late Development Statistics

Lead the interaction with Clinical, Regulatory, Statistical Programming, Data Management, and other Scientists from our Research & Development Division in designing and analyzing clinical trials, and in coordinating the statistical activities for clinical drug/vaccine projects

• Interacts with Academic Research Organization (ARO), Contract Research Organization (CRO) and external statistical consultants
• The incumbent may initially work in a specific disease area
• Serves as statistical representative and lead in the cross-functional teams for the strategic planning and execution for product development
• Lead a team of statistical and/or programing staff assigned to a development project as needed
• Lead biostatistics in early or late clinical development planning to ensure that study designs are consistent with program objectives and meet worldwide regulatory and marketing needs
• Independently identifies and anticipates technical or other potential problems arising in the design, conduct, and analysis of clinical trials, proposes solutions and carries them out
• Develops individual protocols and data analysis plans and independently determines appropriate statistical methodology for analysis
• May lead a team of statisticians and statistical programming staff to ensure that all programs meet analysis requirements, internal standard operating procedures, and external regulatory requirements
• Evaluates appropriateness of available software for planned analyses and ascertains needs for potential program development of novel statistical methodology
• Analyzes data and interprets results from clinical trials to meet objectives of the study protocol
• Independently applies and implements basic and complex statistical techniques to these analyses
• Prepares oral and written reports to effectively communicate results of clinical trials to the project team, our Company's Management, regulatory agencies, or individual investigators
• Represent biostatistics in regulatory interactions including presentation at advisory committee meetings
• Provides responses to queries relating to study design, analysis, and interpretation posed by the clinical monitors, regulatory agencies, and/or investigators
• Participates with management in discussions with corresponding scientific personnel at regulatory agencies and with investigators concerning proposed or ongoing studies
• Lead research activities for innovative statistical methods and applications in clinical trial development
• Collaborates in publication of research results in areas of applications
• Mentors and guides junior staff in functional activities
• Participates in departmental activities including recruiting and training other statisticians, providing statistical training for non-statistical group and other committee works as needed
• Demonstrated ability in statistical research activities and in application of novel methods to clinical trial development
• Publications in peer reviewed statistical/medical journals

This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely

• PhD or equivalent degree in statistics/biostatistics or related discipline with a minimum of 9 years relevant work experience, or a Master’s degree with a minimum of 12 years relevant work experience
• Solid knowledge of statistical analysis methodologies and experimental design
• Strong scientific leadership in design and analysis of clinical trials
• Strong project management skills
• Solid knowledge of statistical and data processing software e.g
• SAS and/or R
• Solid understanding of worldwide regulatory requirements and clinical trial expertise from phase II to V
• Excellent oral and written communication skills and strong leadership in a team environment

Must also demonstrate the ability to learn, be proactive and motivated, and consistently focus on details and execution

Biostatistics, Clinical Development, Clinical Trial Management Processes, Clinical Trials, Clinical Trials Analysis, Data Analysis, Data Management, Data Science, Numerical Analysis, Project Management, Regulatory Compliance, Regulatory Requirements, Scientific Leadership, Scientific Modeling, Statistical Analysis, Statistical Programming, Statistics, Strategic Planning

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