Sr. Statistician, CMC

Job Description

In BARDS (Biostatistics and Research Decision Sciences) a distinguished department within our companys 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.

Education and Minimum Requirement:

• Masters degree in statistics or related discipline with a minimum of 3 years relevant experience.

• A minimum of 12 months experience in large molecule drug substance process characterization.

Required Skills and Experience:

• This is a hands-on project facing position and must have demonstrated experience interacting with large molecule drug substance process characterization teams.

• Must have demonstrated experience of effectively working remotely; Must be able to travel to Rahway site as business needs dictate.

• Proven experience applying DOE to real-life large molecule drug substance process characterization problems.

• Proven experience with large molecule drug substance process characterization study data management in structured database (e.g. RLIMS)

• Proven experience of statistical analysis methodologies for mixed-effects models including variable selection and experimental design.

• Proven experience generating simulations for PAR setting generating impact ratios and other details for parameter classification.

• Strong hands-on experience with JMP and working knowledge of other statistical and data processing software.

• Must also demonstrate the ability to learn be proactive and motivated and consistently focus on details and execution.

• Strong oral and written communication skills. Able to function effectively in a fast paced team environment. Flexibility is critical.

Responsibilities:

• Willing to learn and use the internal computing platform.

• Develop study design (DOE) statistical analysis and reported output using in-house developed JMP tools in fast-paced critical path projects.

• Provide expert second statistician review of drug substance process characterization studies.

• Participate on drug substance process characterization teams to understand requirements to design study experiments and discuss results. Experiment design entails having joint conversations with the Process scientists/engineers to discuss the issues and constraints on study design and execution.

• Work with Process Scientists/Engineers to complete study reports as needed.

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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 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

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 employees 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 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

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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.

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