Senior Principal Scientist, Biostatistics

Job Description

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.

Role Responsibilities:

• 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 our Company Research Laboratories Scientists in designing and analyzing clinical trials, and in coordinating the statistical activities for clinical drug/vaccine projects.
• Interacts with Academic Research Organization, Contract Research Organization and external statistical consultants.

Primary activities:

• 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 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
  

Education and Minimum Requirement:

• PhD or equivalent degree in statistics/biostatistics or related discipline with a minimum of 9 years relevant work experience, or
• Master’s degree with a minimum of 12 years relevant work experience.
  

Required Skills and 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 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.
• Demonstrated ability in statistical research activities and in application of novel methods to clinical trial development.
• Publications in peer reviewed statistical/medical journals.
• Must also demonstrate the ability to learn, be proactive and motivated, and consistently focus on details and execution.

Preferred Skills and Experience:

• An understanding of biology of disease and drug discovery and development.

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BARDS2020

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Where required by law, the compensation range for this role is provided below.

The salary range for the primary location of this role is:

This range reflects the Company's reasonable expectation of the base salary applicable to this role at the time of 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.

Additional location(s): Please note the salary range above applies to the Primary Location of the position. Where a role has other listed locations, different compensation guidelines may apply. You may find the salary ranges for additional locations below. If the salary range is not listed for the location you are applying to, our Talent Acquisition team will provide further information to you relevant to your location.

Additional location(s) Compensation Information:

San Francisco Residents Only: We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance

Los Angeles Residents Only: We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles’ Fair Chance Initiative for Hiring Ordinance

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Requisition ID:R423600