Education Minimum Requirement: BA/BS in Computer Science, Statistics, Applied Mathematics, Life Sciences, Engineering or related field plus 5-9 years SAS programming experience in a clinical trial environment MS in Computer Science, Statistics, Applied Mathematics, Life Sciences, Engineering or related field plus 3-7 years SAS programming experience in a clinical trial environment Required Experience and Skills: Department Required Skills and Experience: - Effective interpersonal skills and ability to negotiate and collaborate effectively
- Effective written, oral, and presentation skills
- Effective knowledge and experience in developing analysis and reporting deliverables for R&D projects (data, analyses, tables, graphics, listings)
- A project leader; completes tasks independently at a project level; ability to collaborate with key stakeholders
Position Specific Required Skills and Experience: - Significant expertise in SAS and clinical trial programming including data steps, procedures, SAS/MACRO, SAS/GRAPH; systems and database expertise
- Designs and develops complex programming algorithms
- Ability to comprehend analysis plans which may describe methodology to be programmed; an understanding of statistical terminology and concepts
- Familiarity with clinical data management concepts
- Experience in CDISC and ADaM standards
- Experience ensuring process compliance and deliverable quality
- Strategic thinking - ability to turn strategy into tactical activities; design of statistical databases with the end in mind that optimize analysis and reporting and leverage departmental standards and industry best-practices
- Ability to anticipate stakeholder requirements
Preferred Experience and Skills: - Demonstrated success in the assurance of deliverable quality and process compliance. Strong working knowledge of reporting processes (SOPs) and software development life-cycle (SDLC)
- US and/or worldwide drug or vaccine regulatory application submission experience including the development of electronic submission deliverables
- Experience assuring programming consistency across protocols and projects, directing the program development effort of other programmers; experience as a programming mentor
- 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 professional societies
- Experience in process improvement
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. For more information about personal rights under Equal Employment Opportunity, visit: EEOC Poster EEOC GINA Supplement |
