Scientist, Statistical Programming, Early-Stage Oncology (Hybrid)
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Job description
In BARDS (Biostatistics and Research Decision Sciences), a distinguished department within our Company’s renowned Research and Development division, quantitative scientists, in partnership with other subject matter experts, apply state-of-the art scientific methodologies and tools to enable the discovery, development, regulatory approval, manufacturing, and marketing of medical drugs and vaccines for the benefit of patients and global human health.
This position supports statistical programming activities for early-stage oncology clinical development projects. Accountability predominantly includes the development and execution of statistical analysis and reporting datasets, tables, listings, figures and submission deliverables under the guidance of a senior level programmer. The statistical programmer will perform validation tasks according to departmental SOPs and collaborate effectively with outsource partner on medical monitoring reports development, validation, and deployment.
The position is a key collaborator with statistics and other project stakeholders to gather and document user requirements for statistical programming deliverables.
Primary Activities:
- Programmatically develop, validate and maintain efficacy and safety datasets, tables, listings, and figures at a protocol level
- Assure deliverable quality and compliance with departmental SOPs and good programming practices
- Collaborate effectively with project team members including outsource provider staff
Requirements
- BA/BS in Computer Science, Statistics, Applied Mathematics, Life Sciences, Engineering or related field plus a minimum of 2 years SAS programming experience in a clinical trial environment
- MS in Computer Science, Statistics, Applied Mathematics, Life Sciences, Engineering or related field
- R programming is highly preferred
Department Required Skills and Experience:
- Good interpersonal skills and ability to negotiate and collaborate effectively
- Good written, oral, and presentation skills
- Knowledge and experience in developing analysis and reporting deliverables for R&D projects (data, analyses, tables, graphics, listings)
- Takes direction effectively and completes tasks at a project level; ability to collaborate with key stakeholders
Position Specific Required Skills and Experience:
- SAS programming experience including data steps, procedures, SAS/MACRO, SAS/GRAPH
- Ability to quickly and effectively learn new program techniques and data structures
- Takes direction effectively and completes programming tasks under the guidance of a senior programmer at a project level
- Knowledge in CDISC SDTM and ADaM standards
- An interest to advance career by investing in development activities and taking on tasks with increasing levels of challenge and responsibility
Preferred Skills and Experience:
- R programming experience, including data derivation and analysis is analysis highly preferred
- Knowledge of pharmaceutical development processes and clinical endpoint data (efficacy and safety)
- Unix operating system experience; systems and database experience
- Good working knowledge of reporting processes (SOPs) and software development life cycle, Accountability, Base SAS, Base SAS Procedures, CDISC ADaM, Clinical Development, Computer Programming, Computer Science, Data Management, Data Modeling, Drug Development, Interpersonal Communication, Negotiation, Numerical Analysis, Oncology, Oncology Research, Pharmaceutical Process Development, Presentation Delivery, Project Leadership, SAS System, Stakeholder Relationship Management, Statistical Programming, Unix Operating Systems, Waterfall Model
About the company
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.
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