Principal Scientist, Process Control and Data Analytics

Merck; Rahway (NJ); Hybrid; USD 153,000 - 243,000; Full time

Job summary

An established industry player is seeking a Principal Scientist to lead a team focused on statistical analysis and product control strategies for medical devices. This pivotal role requires expertise in advanced statistical methods and a strong background in data science. The ideal candidate will mentor a high-performing team while ensuring product quality and regulatory compliance. Join a dynamic environment that fosters innovation and collaboration, where your contributions will directly impact the development of cutting-edge medical solutions. If you are passionate about data analytics and leadership, this opportunity is perfect for you.

Benefits

Health Care Benefits

Retirement Benefits

Paid Holidays

Vacation Days

Sick Days

Bonus Eligibility

Long Term Incentives

Qualifications

• 8+ years of experience in statistical analysis in the medical device industry.
• Strong background in statistical process control and regulations.

Responsibilities

• Lead a team in developing product control strategies and statistical analysis.
• Implement statistical process control methodologies for quality assurance.

Skills

Statistical Analysis

Data Science

Statistical Process Control

Advanced Statistical Methods

Leadership

Communication Skills

Education

Master's or Ph.D. in Statistics

Master's or Ph.D. in Data Science

Master's or Ph.D. in Engineering

Tools

Statistical Software

Data Analysis Tools

Job description

Job Description

The Principal Scientist, Process Control and Data Analytics will be responsible for leading a team focused on developing and implementing product control strategies, statistical analysis, and advanced statistical methods for medical device and combination product engineering within the pharmaceutical company. The position requires a strong understanding of statistical principles, expertise in medical devices and combination product processes, and analytical testing for devices, as well as the ability to enhance the organization's big data skill set and connect with digital efforts. The ideal candidate will have a background in data science, statistics, and a strong understanding of medical device and combination product regulations and processes. It is expected that this role will lead significant investigations or events directly, and mentor and coach their team to provide on-going support.

Essential Duties and Responsibilities:

• Lead and manage a team of subject matter experts focusing on product control strategies, statistical analysis, and advanced statistical methods, including principal component analysis, etc.
• Develop and implement statistical process control methodologies and data anlaysis to ensure the quality and reliability of autoinjector and syringe products, and other medical device and combination products. Ensure these efforts are integrated with the product stewardship organization.
• Through team members analyze and issue routine data reports and analysis, such as product complaints and on-going performance data, to drive deeper technical understanding and proactive problem identification and resolution.
• Through team members, rapidly and thoroughly map process control strategies across processes end to end, analyzing tests methods and controls, to generate a comprehensive assessment of product performance. Identify critical attributes, and create and implement prospective monitoring plans
• Ensure data analysis using structured and modern data science techniques, and provide mentorship and training to build the team's capabilities.
• Ensure seamless interface in the Device Development and Technology team including process stewardship and technical transfer functions. Act as a liaison between the device process teams and partner groups including the statistical centers of excellence, quality, sites, and digital and other departments.

Qualifications:

• Master's or Ph.D. in Statistics, Data Science, Engineering, or related field.
• Minimum of 8 years of experience in statistical analysis and statistical process control within the medical device or pharmaceutical industry.
• In-depth knowledge of medical device and combination product regulations, manufacturing processes, and quality control.
• Proficiency in advanced statistical methods, such as partial least squares regression, multivariate analysis, and design of experiments.
• Demonstrated leadership and management experience, including the ability to build and develop high-performing teams.
• Strong communication and interpersonal skills, with the ability to collaborate with cross-functional stakeholders and interface with other departments.

Preferred Qualifications:

• Experience in leveraging big data and digital technologies for statistical analysis and product control strategies.
• Background in data science and machine learning techniques for analyzing complex datasets.
• Knowledge of Six Sigma methodologies and structured problem-solving approaches.
• Experience with technical transfer and lifecycle support for medical devices and combination products.

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:

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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.

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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 Company is required to provide a reasonable estimate of the salary range for this job in certain states and cities within the United States. Final determinations with respect to salary will take into account a number of factors, which may include, but not be limited to the primary work location and the chosen candidate’s relevant skills, experience, and education.

Expected US salary range:

$153,800.00 - $242,200.00

Available benefits include bonus eligibility, long term incentive if applicable, health care and other insurance benefits (for employee and family), retirement benefits, paid holidays, vacation, and sick days. A summary of benefits is listed here.

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:

05/13/2025

*A job posting is effective until 11:59:59PM on the day BEFOREthe 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:R346466