Senior Scientist, Statistical Programming

Merck•Rahway, NJ

13h•$117,000 - $184,200•Onsite

About The Position

Provide support to statistical programming activities for late-stage drug/vaccine clinical development projects. Be accountable for 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. Design and maintain statistical datasets that support multiple stakeholder groups which include clinical development, outcomes research and safety evaluation. Act as a key collaborator with statistics and other project stakeholders in ensuring that project plans are executed efficiently with timely and high quality deliverables. Serve as the statistical programming point of contact and knowledge holder through the entire product lifecycle. 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. Lead one or more projects.

Requirements

Master’s degree (or US equivalent) in Computer Science, Statistics, Applied Mathematics, Life Sciences, Engineering or related field plus 3 years experience in SAS programming in a clinical trial environment OR a Bachelor’s degree (or US equivalent) in Computer Science, Statistics, Applied Mathematics, Life Sciences, Engineering or related field plus 5 years experience in SAS programming in a clinical trial environment.
Experience in CDISC and ADaM standards.
Experience in designing and developing complex programming algorithms and ensuring process compliance and deliverable quality.
Must possess expertise in SAS and clinical trial programming including data steps, procedures, SAS/MACRO, SAS/GRAPH.
Systems and database expertise.
Must have ability to comprehend analysis plans which may describe methodology to be programmed.
Have an understanding of statistical terminology and concepts; strategic thinking ability to turn strategy into tactical activities.
Ability to 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.
Familiarity with clinical data management concepts.
Effective interpersonal skills and ability to negotiate and collaborate effectively.
Written, oral, and presentation skills.
Knowledge and experience in developing analysis and reporting deliverables for R&D projects (data, analyses, tables, graphics, listings) also required.
Must be a project leader and possess ability to complete tasks independently at a project level.
Ability to collaborate with key stakeholders.

Responsibilities

Provide support to statistical programming activities for late-stage drug/vaccine clinical development projects.
Be accountable for 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.
Design and maintain statistical datasets that support multiple stakeholder groups which include clinical development, outcomes research and safety evaluation.
Act as a key collaborator with statistics and other project stakeholders in ensuring that project plans are executed efficiently with timely and high quality deliverables.
Serve as the statistical programming point of contact and knowledge holder through the entire product lifecycle.
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.
Lead one or more projects.