Senior Scientist, Statistical Programming

Responsibilities

• Support statistical programming activities for clinical trial data analysis.
• Develop SAS programs to create and validate analysis datasets (ADaM) and summaries (TFLs) in support of Clinical Study Reports and regulatory submissions (FDA, EMA, etc.).
• Collaborate with biostatisticians, project leads, and other stakeholders in ensuring project plans are executed efficiently with timely and high-quality deliverables.
• Develop effective study and report programming and validation utilizing global CDISC, ICH, and Therapeutic Areas standards and following departmental SOPs and good programming practices.
• Maintain and manage a project plan including resource forecasting. Coordinate activities of a global programming team. Participate in departmental strategic initiative teams.

Requirements

• Must have 3 years of experience with all the following:
• Developing analysis and reporting deliverables for Phase 2 and 3 clinical trials, including creation of analysis datasets, tables, graphics, and listings, for planned and unplanned analyses.
• SAS programming in a clinical trial environment including data step and procedures, macros, graphics, ODS.
• Interpreting and executing on clinical trial statistical analysis plans.
• Utilizing CDISC standards to create ADaM and SDTM datasets.
• Designing and developing complex programming algorithms.
• Ensuring process compliance and deliverable quality.
• Required Skills:
• Preferred Skills:
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• Current Contingent Workers apply HERE
• US and Puerto Rico Residents Only:
• EEOC Know Your Rights
• EEOC GINA Supplement
• San Francisco Residents Only: We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance
• Los Angeles Residents Only: We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance
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• Employee Status:
• Regular
• Relocation:
• No relocation
• VISA Sponsorship:
• No
• Travel Requirements:
• No Travel Required
• Flexible Work Arrangements:
• Not Applicable
• Shift:
• Not Indicated
• Valid Driving License:
• Hazardous Material(s):
• n/a
• Job Posting End Date:
• 08/19/2026 *A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.

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