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. Today, we are building a new kind of healthcare company - one that is ready to help create a healthier future for all of us.
Our ability to excel depends on the integrity, knowledge, imagination, skill, diversity and teamwork of an individual like you. To this end, we strive to create an environment of mutual respect, encouragement and teamwork. As part of our global team, you'll have the opportunity to collaborate with talented and dedicated colleagues while developing and expanding your career.
- This position manages programmers responsible for statistical programming activities for multiple late stage (phase II - IV) drug/vaccine clinical development projects, in one or multiple therapeutic areas.
- The incumbent is responsible for implementing departmental objectives and managing resource and operational challenges.
- The position ensures appropriate and consistent application of SOPs, standards and quality and compliance measures.
- Provides technical and/or scientific guidance to employees and colleagues.
- Contributes to building and fostering group capability for the delivery of expertise, and behaviors required to deliver success on projects.
- Position is responsible for hiring appropriate, qualified staff; performance management and employee development including coaching and mentoring; training plan management.
Education Minimum Requirement:
- Bachelors or Master's (preferred) Degree or equivalent in Computer Science, Statistics, Applied Mathematics, Biological Sciences, or Engineering.
Required Experience and Skills:
- BS plus 9-12 years or MS plus 7 years SAS programming experience in a clinical trial environment.
- Experience managing a team of statistical programmers in the development and execution of statistical analysis and reporting deliverables (e.g. safety and efficacy analysis datasets, tables, listings, figures) in one or multiple therapuetic areas (TA).
- Broad knowledge and demonstrated experience in developing analysis and reporting statistical programming deliverables using global and TA standards and according to quality, compliance and timeliness requirements.
- Expertise in SAS and clinical trial programming including data steps and procedures; systems and database expertise; Familiarity with statistical analysis methods and clinical data management concepts.
- Knowledge of regulatory agency requirements pertaining to statistical computing and programming issues.
- Experience managing and forecasting programming resources at the project and therapeutic area level.
- Excellent communication and negotiation skills with a demonstrated history of teamwork and collaboration; deals well with change and seamlessly assimilates to new projects and stakeholders; ability to engage key stakeholders.
- Strategic thinking - ability to turn strategy into tactical activities and operational objectives.
- Ability to anticipate stakeholder and regulatory requirements.
Preferred Experience and Skills:
- US and/or worldwide drug or vaccine regulatory application submission experience at the leadership level including the development of electronic submission deliverables.
- Demonstrated success in the assurance of deliverable quality and process compliance. Strong working knowledge of reporting processes (SOPs) and software development life-cycle (SDLC)
- Ability and interest to work across cultures and geographies.
- Experience leading the activities of a programming team that includes outsource-partner, contractor, and global resources.
- 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.
- Experience contributing to project resource allocation and forecasting activities at the late-stage development portfolio level.
- Experience in CDISC and ADAM standards.
- Active in professional societies.
- Experience in process improvement.
Our employees are the key to our company's success. We demonstrate our commitment to our employees by offering a competitive and valuable rewards program. Our Company's benefits are designed to support the wide range of goals, needs and lifestyles of our employees, and many of the people that matter the most in their lives. If you need an accommodation for the application process please email us at email@example.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.
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