Job Description
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:
Master’s degree or equivalent in Computer Science, Statistics, Applied Mathematics, Biomedical Engineering, or a closely related field and 3 years of experience in the position offered or a related role; OR a Bachelor's degree or equivalent in Computer Science, Statistics, Applied Mathematics, Biomedical Engineering, or a closely related field and 5 years of experience in the position offered or a related role.
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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**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:
No
Hazardous Material(s):
n/a
Job Posting End Date:
08/19/2026
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