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 supports statistical programming activities for late stage drug/vaccine clinical development projects. This may include leadership of one or more projects. Accountability predominantly includes the development and execution of statistical analysis and reporting deliverables (e.g. safety and efficacy analysis datasets, tables, listings, figures), the span of which range from individual clinical trials to world-wide regulatory application submissions and post marketing support.
The incumbent is responsible for the design and maintenance of statistical datasets that support multiple stakeholder groups which include clinical development, outcomes research and safety evaluation.
The position is a key collaborator with statistics and other project stakeholders in ensuring that project plans are executed efficiently with timely and high quality deliverables.
For assigned projects the position serves as the statistical programming point of contact and knowledge holder through the entire product lifecycle.
- Effective analysis and report programming development and validation utilizing global and TA standards and following departmental SOPs and good programming practices.
- Maintain and manage a project plan including resource forecasting.
- Coordinate the activities of a global programming team that includes outsource provider staff.
- Membership on departmental strategic initiative teams.
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.
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 firstname.lastname@example.org. Search Firm Representatives Please Read Carefully:
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