Principal Scientist Statistical Programming - SDTM Job

Principal Scientist Statistical Programming - SDTM-STA000847

Description

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.

The Principal Scientist, Statistical Programming - SDTM, focuses on strategic activities impacting creation of SDTM deliverables for analysis and reporting and world-wide regulatory application submissions of drug and vaccine clinical development projects to the direct benefit of clinical development project teams.
The position is a key collaborator with internal and external stakeholders including Statistical Programming, Statistics, Regulatory, Data Management, Clinical and other project stakeholders.
Accountability predominantly includes creation and validation of SDTM study data standard deliverables (SDTM dataset, Define.XML, SDRG, aCRF), collaborating and consulting with project teams, outreach to external vendors and partners, and keeping current with industry submission data standards.

Primary Activities:

- Address operational challenges that require strategic solutions resulting in improved regulatory submissions in both timeliness and quality
- Oversight of SDTM deliverable creation for A&R and submission including up-versioning
- Oversight of the use of Pinnacle 21 Enterprise to ensure compliance of CRT deliverables,
- Leadership in industry teams and conferences on best practices
- Leadership on departmental strategic initiative project teams

Qualifications

Education:

- BA/BS in Computer Science, Statistics, Applied Mathematics, Life Sciences, Engineering or related field plus 12 years SAS programming experience in a clinical trial environment
- MS (preferred) in Computer Science, Statistics, Applied Mathematics, Life Sciences, Engineering or related field plus 10 or more years SAS programming experience in a clinical trial environment

Required:

- US and/or worldwide drug or vaccine regulatory application submission experience at the leadership level including the development of study data standards for electronic submissions
- Superior knowledge with study data standards CDISC (SDTM, ADaM), Define.XML, SDRG, ADRG, aCRF
- Superior knowledge and significant experience in setting strategy and developing SDTM and analysis and reporting deliverables for R&D projects (data, analyses, tables, graphics, listings)
- Excellent interpersonal skills and ability to negotiate and collaborate effectively
- Excellent written, oral, and presentation skills
- Excels in technical writing, able to convert complex ideas and information into simple readable form
- Excellent project management skills; leadership across multiple and complex programs; determines approach and ensures consistency and directs effort others; ability to engage key stakeholders
- Demonstrated success in the assurance of deliverable quality and process compliance.
- Familiarity with statistics and clinical data management concepts

Preferred:

- Experience in process assessment, improvement and operational excellence methodologies
- Strong working knowledge of reporting processes (SOPs) and software development life-cycle (SDLC)
- Experience providing technical and/or programming guidance and mentoring to colleagues
- Deals well with change and seamlessly assimilates to new projects and stakeholders
- Ability and interest to work across cultures and geographies
- Ability to complete statistical programming deliverables through the use of global outsource partner programming staff
- Experience developing and managing a project plan using Microsoft Project or similar package
- Active in industry forums and professional societies
- Experience with Meta Data Repositories
- Strategic thinking - ability to analyze operational activities and challenges and develop and implement strategic solutions
- Ability to anticipate stakeholder requirements

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 an accommodation for the application process please email us at staffingaadar@merck.com.

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Job: Statistical Programming

Job Title:Prin. Scientist, Stat. Programming

Primary Location: NA-US-PA-Upper Gwynedd

Other Locations: NA-US-NJ-Rahway

Employee Status: Regular

Travel: Yes, 10 % of the Time

Number of Openings: 1

Shift (if applicable): N/A

Company Trade Name:Merck