Principal Scientist, Biostatistics, Late-Stage Clinical Development

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. This position is for a principal scientist in biostatistics. The candidate should have a solid knowledge of statistical methodology, experimental design, computing software and data management; a general understanding of worldwide regulatory requirements; and with good clinical trial experience in Phase II/ III trials. The knowledge must be sufficient to ensure that sound scientific principles and statistical methods applied to designing and analyzing clinical trials in support of worldwide regulatory submissions. This position involves interaction with Medical, Data Coordination, Statistical Programming, our Research & Development Division scientists and Regulatory staffs in designing and analyzing clinical trials and coordinating the statistical activities for clinical trial projects; and may lead a group of statistical or programming staff assigned to a development project as needed. More specifically, Develops, coordinates, and provides biostatistical support for drug projects under the supervision of management. Lead a team of staff assigned to the project as needed. This includes the following activities: Is involved in late clinical development planning (LDP) 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 data analysis. Participates in Worksheet development, database (collector and view) design meetings to ensure that the data evaluated are free of bias, contain maximum information (minimum variance), and satisfy analysis requirements. Determines the statistical programming needs and organizes the programming activities to ensure that all programs meet analysis requirements, internal standard operating procedures, validation, 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 experiments to meet objectives of the study protocol. Independently applies and implements basic and complex 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. Provides responses to queries relating to study design, analysis, and interpretation posed by the clinical monitors, regulatory agencies, or investigators. Responsible for ensuring the accuracy of Statistical Review Aids submitted to regulatory agencies. Participates with management in discussions with corresponding technical personnel at regulatory agencies and with investigators concerning proposed or ongoing studies. Collaborates in publication of research results in areas of applications. Independently conducts research on statistical methodology, pursues solutions to various technical problems, adapts known methods and develops new methods. Maintains technical skills and increases own knowledge of new methods or areas of applications by reading journals and attending professional society meetings. Presents own research at meetings and seminars. Communicates with statisticians outside our Company's concerning technical problems. Participates in departmental activities including recruiting and training other statisticians, providing statistical training for non-statistical groups, department research effort, and other committee works, etc., as needed. Position Qualifications : Education Minimum Requirement: Ph.D. (preferred) or MS in Biostatistics or Statistics Required Experience and Skills : With a MS, a minimum of 9 years relevant work experience; with a Ph.D., a minimum of 6 years relevant work experience. Preferred Experience and Skills: Scientific leadership in design and analysis of clinical trials; Experience with regulatory filing for approval of drug/vaccine products; Regulatory submission experience strongly preferred; Prior experiences with respiratory and immunology disease areas are desired. BARDS2020 #eligibleforERP Required Skills: Biostatistics, Clinical Trial Management, Clinical Trials, Clinical Trials Analysis, Computing Software, Data Management, Data Science, Numerical Analysis, Regulatory Compliance, Regulatory Requirements, Scientific Leadership, Scientific Modeling, Standard Operating Procedure (SOP), Statistical Analysis Preferred Skills: Current Employees apply HERE Current Contingent Workers apply HERE US and Puerto Rico Residents Only: Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process. As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics. As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit: EEOC Know Your Rights EEOC GINA Supplement​ We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively. Learn more about your rights, including under California, Colorado and other US State Acts The salary range for this role is $190,800.00 - $300,300.00 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 . You can apply for this role through (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting. 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 Search Firm Representatives Please Read Carefully Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. Employee Status: Regular Relocation: Domestic VISA Sponsorship: Yes Travel Requirements: 10% Flexible Work Arrangements: Hybrid Shift: Not Indicated Valid Driving License: No Hazardous Material(s): n/a Job Posting End Date: 08/7/2026 *A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.