Sr. Scientist, Statistical Programmer, Late Stage Development Oncology- Hybrid

Merck-posted 3 months ago

$114,700 - $180,500/Yr

Full-time

North Wales, PA

5,001-10,000 employees

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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.

Support statistical programming activities for late stage drug/vaccine clinical development projects.
Lead one or more projects and ensure accountability for the development and execution of statistical analysis and reporting deliverables.
Design and maintain statistical datasets that support multiple stakeholder groups including clinical development, outcomes research, and safety evaluation.
Collaborate with statistics and other project stakeholders to ensure efficient execution of project plans with timely and high quality deliverables.
Serve as the statistical programming point of contact and knowledge holder through the entire product lifecycle.
Develop and validate analysis and report programming utilizing global and TA standards.
Maintain and manage a project plan including resource forecasting.
Coordinate the activities of a global programming team that includes outsource provider staff.
Participate in departmental strategic initiative teams.

BA/BS in Computer Science, Statistics, Applied Mathematics, Life Sciences, Engineering or related field plus 5 years SAS programming experience in a clinical trial environment.
MS in Computer Science, Statistics, Applied Mathematics, Life Sciences, Engineering or related field plus 3 years SAS programming experience in a clinical trial environment.
Effective interpersonal skills and ability to negotiate and collaborate effectively.
Effective written, oral, and presentation skills.
Knowledge and experience in developing analysis and reporting deliverables for R&D projects.
Ability to complete tasks independently at a project level and collaborate with key stakeholders.
Significant expertise in SAS and clinical trial programming including data steps, procedures, SAS/MACRO, SAS/GRAPH.
Ability to comprehend analysis plans and understand 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 and ability to design statistical databases that optimize analysis and reporting.

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.
Experience assuring programming consistency across protocols and projects.
Ability and interest to work across cultures and geographies.
Experience developing and managing a project plan using Microsoft Project or similar package.
Active in professional societies.
Experience in process improvement.

Medical, dental, vision healthcare and other insurance benefits (for employee and family).
Retirement benefits, including 401(k).
Paid holidays, vacation, and compassionate and sick days.

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Sr. Scientist, Statistical Programmer, Late Stage Development Oncology- Hybrid

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