Senior Scientist, Biostatistics, Clinical Safety Statistics (CSS)

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. The Clinical Safety Statistics (CSS) group within BARDS supports proactive assessment, transparent communication, and effective management of product risk profiles across our company Research Laboratories pre- and post-marketing development stages. Responsibilities: Provide statistical support for the evaluation of clinical safety at the project level. Interact with Safety Physicians, Safety Scientists, Clinical Trial Physicians, Regulatory, Early/Late Development Statistics, Statistical Programming, and other our company's Research Laboratories Scientists in the planning and execution of ongoing safety evaluation across pre-marketing and post-marketing development stages Design, develop and evaluate processes and tools for product safety evaluation, including ongoing aggregate safety evaluation Primary activities: Provide statistical support to cross-functional safety teams including strategic planning and scientific reasoning activities that facilitate safety evaluation. Plan and execute ongoing aggregate safety evaluations, including cumulative meta-analysis of safety. Design, develop and apply safety evaluation methods (including enhanced graphics analyses), processes, standards and tools. Collaborate with the Late Development Statistics (LDS) and Statistical Programming (SP) to ensure high quality safety-related deliverables Collaborates with the statistical programming staff to ensure that all programs meet analysis requirements, internal standard operating procedures, and external regulatory requirements. Prepare oral or written reports to effectively communicate results of safety evaluations to the project teams Evaluate appropriateness of available software for planned analyses and ascertain the need for potential program development of novel statistical methodology. Involved in research activities for innovative statistical methods and applications in clinical safety evaluation. Education and Minimum Requirement: PhD or equivalent degree in statistics/biostatistics or related discipline, or a Master's degree with a minimum of 3 years relevant experience. Required Skills and Experience: Knowledge of statistical analysis methodologies and experimental design, particularly in meta-analysis and Bayesian methodologies. Working knowledge of statistical and data processing software e.g. SAS and/or R. Good oral and written communication skills. Able to work effectively with personnel with different functional background. Demonstrate strong interest in statistical research activities and in application of novel methods for clinical safety evaluation. 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. Proficiency with AI to facilitate writing (summaries, reports, manuscripts, etc.), programming, and other types of tasks. BARDS2020 #EligibleforERP Required Skills: Biostatistics, Clinical Risk Management, Clinical Safety, Clinical Trials, Product Safety, Regulatory Compliance, Regulatory Requirements, Scientific Modeling, Statistical Programming, Strategic Planning, Visual Analytics 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 U.S. Hybrid Work Model Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, Monday - Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence. 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. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as "remote". 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. You can apply for this role through https://jobs.merck.com/us/en (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: 05/9/2026 •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. Our company 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 we have codified our legacy for over a century. Our success is backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare.