Principal Scientist, Biostatistics at Merck Sharp & Dohme Corp. /Netherlands

North Wales, Pennsylvania, United States -

Full Time

Start Date

Immediate

Expiry Date

30 May, 26

Salary

300300.0

Posted On

01 Mar, 26

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Biostatistics, Clinical Development, Clinical Trials Analysis, Data Analysis, Data Management, Data Science, Leadership, Numerical Analysis, Product Development, Project Management, Regulatory Compliance, Regulatory Requirements, Scientific Modeling, Statistical Analysis, Statistics, AI/ML Application

Industry

Pharmaceutical Manufacturing

Description

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. Principal Scientist, Biostatistics Are you passionate about biostatistics and eager to make a significant impact in the field of drug and vaccine development? Join our company, where we are at the forefront of research, delivering innovative health solutions that advance the prevention and treatment of diseases in people and animals. As a Principal Scientist in Biostatistics, you will play a critical role in our research & development division, contributing to the design, analysis, and interpretation of clinical trials. Responsibilities: Serve as a statistical lead in project teams. Develop, coordinate, and provide biostatistical leadership and support for related drug/vaccine projects in Late Development Statistics. Interact with Clinical, Regulatory, Statistical Programming, Data Management, and other Research & Development Division Scientists in designing and analyzing clinical trials, and in coordinating the statistical activities for clinical drug/vaccine projects. Interact with Academic Research Organization (ARO), Contract Research Organization (CRO), and external statistical consultants. Serve as statistical representative and lead in the cross-functional teams for the strategic planning and execution for product development. Participate in clinical development planning to ensure that study designs are consistent with program objectives and meet worldwide regulatory and marketing needs. Independently identify and anticipate technical or other potential problems arising in the design, conduct, and analysis of clinical trials, propose solutions, and carry them out. Develop individual protocols and data analysis plans and independently determine appropriate statistical methodology for analysis. Participate in database design meetings to ensure that the data evaluated are of high quality and satisfy analysis requirements. 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. Evaluate the appropriateness of available software for planned analyses and ascertain needs for potential program development of novel statistical methodology. Analyze data and interpret results from clinical trials to meet objectives of the study protocol. Independently apply and implement basic and complex statistical techniques to these analyses. Prepare oral and written reports to effectively communicate results of clinical trials to the project team, Company Management, regulatory agencies, or individual investigators. Provide responses to queries relating to study design, analysis, and interpretation posed by the clinical monitors, regulatory agencies, and/or investigators. Represent biostatistics in regulatory interactions including presentation at advisory committee meetings. Plan and ensure the accuracy of Statistical Review Aids submitted to regulatory agencies. Participate with management in discussions with corresponding scientific personnel at regulatory agencies and with investigators concerning proposed or ongoing studies. Engage in research activities for innovative statistical methods and applications in clinical trial development. Mentor and guide junior staff in functional activities. Education Requirements: PhD or equivalent degree in statistics/biostatistics or related discipline with a minimum of 6 years relevant work experience, or a Master’s degree with a minimum of 9 years relevant work experience. Qualifications: Required Solid knowledge of statistical analysis methodologies and experimental design. Strong project management skills. Solid knowledge of statistical and data processing software (e.g., SAS or R). Good understanding of worldwide regulatory requirements and clinical trial expertise from phase II to V. Strong oral and written communication skills. Able to function effectively in a team environment. Demonstrate strong interest in statistical research activities and in application of novel methods to clinical trial development. Solid knowledge and strong interest in exploring applications of AI/ML to the analysis, validation, and reporting of clinical trial data. Demonstrate the ability to learn, be proactive and motivated, and consistently focus on details and execution. Preferred Publications in peer-reviewed statistical/medical journals. An understanding of biology of disease and drug discovery and development. BARDS2020 #eligibleforERP Required Skills: Biostatistics, Clinical Development, Clinical Trials Analysis, Data Analysis, Data Management, Data Science, Leadership, Numerical Analysis, Product Development, Project Management, Regulatory Compliance, Regulatory Requirements, Scientific Modeling, Statistical Analysis, Statistics 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 $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 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: No Travel Requirements: 10% Flexible Work Arrangements: Hybrid Shift: Not Indicated Valid Driving License: No Hazardous Material(s): n/a Job Posting End Date: 03/2/2026 *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. Requisition ID:R383075

How To Apply:

Incase you would like to apply to this job directly from the source, please click here

Responsibilities

The Principal Scientist will serve as the statistical lead on project teams, coordinating biostatistical leadership and support for late development drug/vaccine projects. This role involves interacting with cross-functional teams, academic organizations, and regulatory agencies to ensure sound study design, analysis, and interpretation of clinical trial data.