Senior Scientist, Statistical Programming

Job Description

Senior Scientist Statistical Programming Rahway NJ:

• Support the centralized management of technology platforms inspections and related process and training for the global Statistical Programming organization to ensure it operates in compliance with departmental and company SOPs regulatory requirements and standards.
• Support the Business System Ownership (BSO) of platforms or applications and corresponding documents and training.
• Work in partnership in managing prioritizing and implementing portfolio projects.
• Drive compliance initiatives change management and communication.
• Support audit and inspections Center of Excellence with audits inspections and CAPA (Corrective Action and Preventive Action) management.
• Engage with operational staff and partners globally. Lead and actively contribute to departmental strategic initiative project teams.
• Maintain SOPs corresponding processes assuring they are of high quality and complaint with regulatory requirements.

Education Requirements:

• Masters degree in Computer Science Statistics Applied Mathematics Information Technology Life Sciences Engineering or related field plus at least 2 years in a clinical trial environment (Analysis & Reporting Information Technology Data Management etc.) in the pharmaceutical industry and at least 3 years SAS or R programming experience

OR

• Bachelors degree in Computer Science Statistics Applied Mathematics Information Technology Life Sciences Engineering or related field plus at least 5 years in a clinical trial environment (Analysis & Reporting Information Technology (IT) Data Management etc.) in the pharmaceutical industry and at least 3 years SAS or R programming experience.

Required Experience and Skills:

• Must have Business Analyst (BA) experience.
• Must possess comprehensive knowledge of reporting processes (SOPs) that align with regulatory requirements (e.g. 21 CFR Part 11 ICH GCPs) and software development life cycle (SDLC)
• Understanding of Statistical Clinical Medical Monitoring and Data Management concepts as applied to drug/vaccine development within the pharmaceutical industry; and broad knowledge of clinical trials processes data structures and corresponding tools used to manage extract analyze & report data.
• Ability to anticipate stakeholder requirements
• Focus on customers
• Ability to listen to and address stakeholders needs and concerns
• Ability and interest to work across cultures and geographies including partnering with statistical programming staff in AP and EU regions and offshore programming resources
• Demonstrated ability to communicate effectively across multiple audiences and clearly explain processes and system functionality to users; and demonstrated success in the assurance of deliverable quality and process compliance also required.
• Must possess effective interpersonal skills and ability to negotiate and collaborate effectively
• Written oral and presentation skills
• Knowledge and experience in developing analysis and reporting deliverables for R&D projects (data analyses tables graphics listings).
• Must be a project leader
• Possess the ability to complete tasks independently at a project level
• The ability to collaborate with key stakeholders.

The salary range for this role is

$114700.00 to $180500.00

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 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 Compensation and Benefits Webpage.

Required Skills:

Preferred Skills:

Current Employees apply HERE

Current Contingent Workers apply HERE

US and Puerto Rico Residents Only:

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 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 anothers thinking and approach problems collectively.

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.

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.

Employee Status:

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Shift:

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Hazardous Material(s):

Job Posting End Date:

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