Job Title: Business System Owner/Associate Principal Scientist, Statistical Programming

Requisition ID: STA000996

Merck & Co., Inc. Kenilworth, N.J., U.S.A. known as Merck in the United States and Canada, is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. The difference between potential and achievement lies in the spark that fuels innovation and inventiveness; this is the space where Merck has codified its legacy for over a century . Merck's success is backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare.

Merck is on a quest for cures and is committed to being the world's premier, most research-intensive biopharmaceutical company. Today, we're doubling down on this goal. Merck Research Laboratories is a true scientific research facility of tomorrow, and will take Merck's leading discovery capabilities and world-class small molecule and biologics R&D expertise to create breakthrough science that radically changes the way we approach serious diseases.

Responsibilities:
This position supports the centralized management of technology, platforms and related process for the global Statistical Programming organization. The individual supports the organization to ensure it operates in compliance with departmental and company SOPs, regulatory requirements and standards.

Primary Activities:
• Business System Ownership of platforms and corresponding processes and training
• Oversight of departmental compliance for processes, training, and technology
• Departmental website development and maintenance
• Engagement with operational staff and partners globally
• Drive compliance initiatives
• Lead and actively contribute to departmental strategic initiative project teams

Qualifications

Education and Minimum Requirement:
BA/BS in Computer Science, Statistics, Applied Mathematics, Life Sciences, Engineering or related field plus 9-12 years SAS programming experience in a clinical trial environment
MS in Computer Science, Statistics, Applied Mathematics, Life Sciences, Engineering or related field plus 7 or more years SAS programming experience in a clinical trial environment


Department Required Skills and Experience:
Excellent interpersonal skills and ability to negotiate and collaborate effectively
Excellent written, oral, and presentation skills
Broad knowledge and significant experience in setting strategy and developing analysis and reporting deliverables for R&D projects (data, analyses, tables, graphics, listings)
Strong project management skills; leadership at a program level; determines approach and ensures consistency and directs development of others when opportunities arise; ability to engage key stakeholders


Position Specific Required Skills and Experience:
Solid experience with documenting 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
SAS programming experience in a clinical trial environment
Experience with CDISC and ADaM standards
Demonstrated success in the assurance of deliverable quality and process compliance
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


Preferred Skills and Experience:
Experience in process assessment, improvement and operational excellence methodologies; Six Sigma
Experience with MS Visio
Experience developing and managing a project plan using Microsoft Project or similar package
Experience with developing training content including videos
Active in professional societies


Your role at Merck is integral to helping the world meet new breakthroughs that affect generations to come, and we're counting on your skills and inventiveness to help make meaningful contributions to global medical advancement. At Merck, we're inventing for life.

If you need assistance and/or a reasonable accommodation due to a disability during the application or the recruiting process, please send a request to staffingaadar@merck.com .

Search Firm Representatives Please Read Carefully:
Merck & Co., Inc. is not accepting unsolicited assistance from search firms for this employment opportunity. Please, no phone calls or emails. All resumes submitted by search firms to any employee at Merck via email, the Internet or in any form and/or method without a valid written search agreement in place for this position will be deemed the sole property of Merck. No fee will be paid in the event the candidate is hired by Merck as a result of the referral or through other means.

Visa sponsorship is not available for this position.

For more information about personal rights under Equal Employment Opportunity, visit:

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Merck is an equal opportunity employer, Minority/Female/Disability/Veteran - proudly embracing diversity in all of it's manifestations.

Job: Statistical Programming
Other Locations: Upper Gwynedd, PA, US
Employee Status: Regular
Travel: Yes, 5 % of the Time
Number of Openings: 1
Shift (if applicable): 1st
Hazardous Materials: no
Company Trade Name: Merck