Senior Programmer, Global Scientific Programmer Job - United States
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 reports to the Director, Statistical Programming (SP), within the Biostatistics and Research Decision Sciences (BARDS) organization and is a member of the Global Process, Portfolio and Platform Standards (GP3S) team supporting SP personnel to ensure they have the processes, systems, tools, training and information they need to operate effectively.
As a member of the GP3S Team, this position contributes to the Statistical Programming department and the overall Quantitative Sciences organization in various ways.
The position serves as an owner/steward of many departmental procedures and systems used by staff to efficiently create quality, compliant analysis and reporting and submission deliverables.
Key areas of focus include:
- Analysis and Reporting processes/procedures and corresponding training;
- Statistical analysis and reporting platforms and medical monitoring utilities;
- Submission standards processes and tools including SDTM up-versioning, case report tabultations, OSI and ICH listings as well as submission data review guidelines (SDRG) and analysis data review guidelines (ADRG)
- Development and support of the departmental project and resource portfolio system;
- Engagement with operational staff and partners globally
- Driving compliance initiatives and serving as leader/member of strategic and cross-departmental teams.
- BA/BS in Computer Science, Statistics, Life Sciences or related field with a minimum of 5 years experience in Statistics, Software Development, Clinical Data Management, Clinical Research, or Database Design & Development OR MS with a minimum of 3 years experience in Statistics, Software Development, Clinical Data Management, Clinical Research, or Database Design & Development
- Good working knowledge of analysis and reporting systems
- Broad knowledge of clinical trials processes, data structures and corresponding tools used to manage, extract, analyze & report data
- Knowledge of statistics, medical monitoring and data management concepts as applied to drug/vaccine development within Pharmaceutical industry
- Project management skills with the ability to track and coordinate projects at a program level
- Ability to organize and manage work to complete tasks independently
- Demonstrated interpersonal skills and ability to communicate effectively with excellent written, oral, and presentation communication skills
- Good interpersonal skills and ability to negotiate and collaborate effectively; Ability to engage key stakeholders
- Understanding of statistical programming and developing Analysis and Reporting deliverables for research and development projects (datasets, analyses, tables, graphics, listings)
- Understanding of operating procedures, regulatory requirements (e.g. 21 CFR Part 11) and software development life-cycle (SDLC)
- J-Review/I-Review knowledge
- Website management
- SDLC knowledge and experience
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.
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Job: Statistical Programming
Job Title:Sr. Scientist, Stat. Programming
Primary Location: NA-US-PA-Upper Gwynedd
Other Locations: NA-US-NJ-Rahway
Employee Status: Regular
Travel: Yes, 5 % of the Time
Number of Openings: 1
Company Trade Name:Merck
Nearest Major Market: Philadelphia
Job Segment: Scientific, Developer, Medical, Pharmaceutical, Law, Engineering, Technology, Healthcare, Science, Legal