Senior Scientist, Statistical Programming

Job Description

Primary Activities:

Provide support to statistical programming activities for late-stage drug/vaccine clinical development projects. Develop and execute 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 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 for assigned projects. Perform effective analysis and report programming development and validation utilizing global and Therapeutic Area (TA) standards and following departmental standard operating procedures (SOPs) and good programming practices. Maintain and manage a project plan including resource forecasting. Coordinate the activities of a global programming team that includes outsource provider staff. Serve as a member on the departmental strategic initiative teams.

Eduactional Qualifications:

• Must have a master’s degree in computer science, Statistics, Applied Mathematics, Life Sciences, Engineering or related field plus at least 3 years SAS programming experience in a clinical trial environment.
• OR a bachelor’s degree in computer science, Statistics, Applied Mathematics, Life Sciences, Engineering or related field plus at least 5 years SAS programming experience in a clinical trial environment.

Positions Required skills and expereince:

• Must have experience in CDISC and ADaM standards and in ensuring process compliance and deliverable quality.
• Significant expertise in SAS and clinical trial programming including data steps, procedures, SAS/MACRO, SAS/GRAPH; and systems and database expertise also required.
• Applicant must also possess effective knowledge and experience in developing analysis and reporting deliverables for R&D projects (data, analyses, tables, graphics, listings).
• Effective interpersonal skills and ability to negotiate and collaborate effectively; effective written, oral, and presentation skills.
• Ability to design and develop complex programming algorithms; the ability to comprehend analysis plans which may describe methodology to be programmed; an understanding of statistical terminology and concepts.
• Familiarity with clinical data management concepts; and ability to anticipate stakeholder requirements.
• Must be project leader with ability to complete tasks independently at a project level and ability to collaborate with key stakeholders.
• Ability to think strategically, specifically ability to turn strategy into tactical activities; and design of statistical databases with the end in mind that optimize analysis and reporting and leverage departmental standards and industry best-practices also required.

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