Senior Scientist,Statistical Programming Job Rahway area,New Jersey USA,IT/Tech

Senior Scientist, Statistical Programming – Rahway, NJ:
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:

Must have a 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.

Required Skills:

Clinical Development
Clinical Trials
Computer Science
Data Management
Data Modeling
Global Health
Marketing
Numerical Analysis
Outcomes Research
Project Leadership
Stakeholder Engagement
Stakeholder Relationship Management
Statistical Analysis
Statistical Programming
Strategic Thinking
Waterfall Model
Working Independently

Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics.

As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit: EEOC Know Your Rights EEOC GINA Supplement We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds.

The fastest way to breakthrough innovation is when people with…