Senior Scientist, Stat. Programming, Late-Stage Development; Hybrid

Overview

In BARDS (Biostatistics and Research Decision Sciences), a distinguished department within our Company's renowned Research and Development division, quantitative scientists collaborate with subject matter experts to apply state-of-the-art methodologies to support discovery, development, regulatory approval, manufacturing, and marketing of medical drugs and vaccines for patients and global health.

• Lead and/or support statistical programming activities for late-stage drug/vaccine clinical development projects, including development and execution of statistical analyses and reporting deliverables (safety and efficacy datasets, tables, listings, figures) across trials and regulatory submissions.
• Design and maintain statistical datasets supporting multiple stakeholder groups (clinical development, outcomes research, safety evaluation).
• Collaborate with statistics and project stakeholders to ensure plans are executed efficiently with timely, high-quality deliverables.
• Serve as the statistical programming point of contact and knowledge holder through the product lifecycle for assigned projects.
• Coordinate activities of a global programming team including outsource provider staff; participate on departmental strategic initiative teams.

• Education Minimum Requirement: BA/BS in Computer Science, Statistics, Applied Mathematics, Life Sciences, Engineering or related field plus a minimum of 5 years SAS programming experience in a clinical trial environment.
• OR MS in Computer Science, Statistics, Applied Mathematics, Life Sciences, Engineering or related field plus a minimum of 3 years SAS programming experience in a clinical trial environment.

• Effective interpersonal, written, oral, and presentation skills; ability to collaborate effectively with stakeholders.
• Experience developing analysis and reporting deliverables for R&D projects (data, analyses, tables, graphics, listings).
• Project leadership: can complete tasks independently at the project level and collaborate with key stakeholders.
• Significant expertise in SAS and clinical trial programming including data steps, procedures, SAS/MACRO, SAS/GRAPH; systems and database expertise.
• Designs and develops complex programming algorithms; ability to comprehend analysis plans and statistical terminology.
• Familiarity with clinical data management concepts; experience with CDISC and ADaM standards.
• Experience ensuring process compliance and deliverable quality; strategic thinking to translate strategy into tactical activities and design of statistical databases that optimize analysis and reporting.

• Working knowledge of R programming for data analysis, automation, and clinical data standards activities.
• Strong working knowledge of reporting processes (SOPs) and software development life-cycle (SDLC); experience ensuring deliverable quality and process compliance.
• Experience with US and/or worldwide drug or vaccine regulatory submissions and electronic submission deliverables; mentoring of other programmers; coordinating programming across protocols and projects.
• Ability to work across cultures and geographies; ability to manage project plans with outsource staff; experience developing and managing project plans using Microsoft Project or similar.
• Active in professional societies; experience in process improvement.
• Experience developing and managing project plans with global outsource partner programming staff.

The salary range for this role is $ - $. This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employee s position within the salary range will be based on several factors including education, qualifications, certifications, experience, skills, location, and business needs.

The successful candidate will be eligible for annual bonus and long-term incentive, if applicable. We offer a comprehensive benefits package including medical, dental, vision, retirement benefits (401(k)), paid holidays, vacation, and paid sick days. More information about benefits is available at

You can apply for this role through  or via the Workday Jobs Hub if you are a current employee. The Final date to receive applications is stated on this posting.

EEO and Compliance
:
As an Equal Employment Opportunity Employer, we prohibit discrimination and provide equal opportunities to all employees and applicants for employment. We comply with all applicable laws, including San Francisco and Los Angeles local ordinances where applicable. We are a federal contractor and comply with affirmative action requirements for protected veterans and individuals with disabilities.