Sr. Statistician – Chemistry, Manufacturing, and Controls (CMC) at Merck Sharp & Dohme Corp. /Netherlands

Upper Gwynedd Township, Pennsylvania, United States -

Full Time

Start Date

Immediate

Expiry Date

21 Jun, 26

Salary

199100.0

Posted On

23 Mar, 26

Experience

10 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Experimental Design, Design of Experiments (DoE), Statistical Process Control (SPC), Continued Process Verification (CPV), ANOVA, ANCOVA, Mixed-Effects Models, Regression, Multivariate Methods, Monte Carlo Simulations, SAS, R, JMP, Minitab, Bayesian Statistics, ICH Guidance

Industry

Pharmaceutical Manufacturing

Description

Job Description Sr. Statistician – Chemistry, Manufacturing, and Controls (CMC) R3 Under the general supervision of a senior staff member in Center for Mathematical Sciences (CMS), the incumbent is responsible for the statistical analysis and evaluation of data to meet the needs of our company’s Manufacturing Division. The individual will, through consultation with employees and teams, provide statistical expertise on experimental design, and the evaluation and interpretation of data. As required, the incumbent will evaluate data for submission to regulatory agencies and pharmacopoeia. Primary Activities Partner with manufacturing teams to define clear objectives, success criteria, and decision points for process studies; select fit-for-purpose tools (e.g., ANOVA, ANCOVA, mixed-effects models). Design and analyze experiments using Design of Experiments (DoE) to understand, optimize, and qualify/validate vaccine manufacturing processes and analytical methods. Support scale-up, technology transfer, and comparability with sound protocols, acceptance criteria, and statistical justifications. Analyze stability and shelf-life studies aligned with International Council for Harmonisation (ICH) guidance; perform degradation modeling, trend analysis, and shelf-life estimation using regression, mixed-effects models, and tolerance/prediction intervals. Establish and maintain ongoing monitoring using Statistical Process Control (SPC) and Continued Process Verification (CPV) for Critical Quality Attributes (CQAs) and Critical Process Parameters (CPPs); implement control charts (e.g., X-bar/R, Individuals-Moving Range), capability analysis (Cp/Cpk/Pp/Ppk), and nonparametric trend tests as needed. Troubleshoot issues, including Out-of-Specification (OOS) and Out-of-Trend (OOT) results, using data analysis, root-cause hypotheses, and targeted confirmation studies; apply multivariate methods (e.g., PCA, PLS) and Monte Carlo simulations for risk and sensitivity analysis. Translate results into practical recommendations for setpoints, ranges, sampling plans, and control strategies; based on risk and uncertainty. Develop reproducible, auditable analysis using good manufacturing/documentation practices. Prepare clear statistical content for Chemistry, Manufacturing, and Controls (CMC) documentation; assist with regulatory queries using sound statistical rationales. Minimum Education Requirements and Experience: Bachelor of Science (BS) in statistics or related field with ten (10) years of required experience, OR Master of Science (MS) in statistics or related field with five (5) years of required experience, OR PhD in statistics or related field with no required experience. Please note: Coursework and/or experience should include industrial statistics (DOE, SPC, regression, general linear models, and multivariate methods, computer programming). Required Skills and Experience: A statistician experienced working in a pharmaceutical company dedicated to supporting vaccine manufacturing, emphasizing critical thinking, domain knowledge, and scientific partnership. Demonstrated experience supporting Chemistry, Manufacturing, and Controls (CMC) activities for drug substance and drug products, including stability studies, comparability assessments, process validation, and control strategy development aligned with ICH guidelines Working experience with Bayesian statistical framework Background in mammalian cell culture and yeast fermentation Proficient in live virus potency (plaque assays, TCID50, qPCR/dPCR) and recombinant protein analytics (ELISA, HPLC/UPLC). Excellent statistical computing skills with substantial experience in at least two of the following statistical software packages: SAS, R, JMP, Minitab. Hands-on experience with Design of Experiments (DoE), Analysis of Variance (ANOVA), Analysis of Covariance (ANCOVA), mixed-effects models, response surface methods, process capability, Statistical Process Control (SPC), Continued Process Verification (CPV), tolerance intervals, equivalence/non-inferiority testing, and Monte Carlo simulations Strong consulting skills with the ability to work independently and collaboratively across cross-functional teams. Excellent oral and written communication skills; able to explain statistical concepts and results to non-statisticians and influence decision-making Proven leadership with advanced problem-solving and decision-making skills; adept at managing multiple projects, meetings, time, and priorities Ability to think originally and creatively to develop practical, high-impact solutions and to persuade and motivate others toward adoption Required Skills: Accountability, Accountability, Bayesian Statistics, Business Intelligence (BI), Capability Analysis, Cell-Based Assays, Cell Cultures, Computer Programming, Control Charts, Data Analysis, Database Design, Data Engineering, Data Modeling, Data Science, Data Visualization, Machine Learning (ML), Mammalian Cell, Mammalian Cell Culture, Manufacturing, Manufacturing Processes, Manufacturing Support, Mixed Models, Response Surface Methodology, SAS Language, Software Development {+ 9 more} 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 $126,500.00 - $199,100.00 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: Not Applicable Shift: 1st - Day Valid Driving License: No Hazardous Material(s): N/A Job Posting End Date: 03/27/2026 *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:R373127

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Responsibilities

The incumbent provides statistical expertise on experimental design, data evaluation, and interpretation for the Manufacturing Division, partnering with teams to define objectives and success criteria for process studies. Primary activities include designing and analyzing experiments for process qualification, supporting scale-up, analyzing stability studies, and establishing ongoing monitoring using SPC and CPV.