Qualifications
- Bachelor's (BS/BA) or Master’s (MS) degree in computer science, statistics, biostatistics, mathematics, or related field (or equivalent combination of education and experience).
- At least 2 years of SAS programming experience in a clinical trial environment.
- Proficient SAS programming skills, including PROC and DATA steps, macros, and PROC REPORT.
- Experience programming SDTM and ADaM datasets in compliance with CDISC standards.
- Experience programming tables, listings, and figures (TLFs) in accordance with the Statistical Analysis Plan (SAP).
- Exposure to data definition files (including define.xml), annotation of case report forms (CRFs) and data reviewer guides.
- Ability to multi-task, prioritize, negotiate, analyze and solve problems, manage competing priorities, meet timelines, and work independently is required.
- Excellent communication skills; ability to work within a cross functional team; and strong attention to detail are encouraged.
Skills
- Required: Clinical, SAS, CDISC, SDTM, ADaM, tables, figures, listings (or TFLs, TLGs, TLFs), Pinnacle 21, DEFINE.xml, safety, efficacy, macros.
- Encouraged: Statistics, modeling, integration (ISS, ISE, ISI, CSS, CSE - clinical summary of Safety/Efficacy, Integration summary of immunogenicity, etc), submission, Phase I, II, III, IV, and SQL.
Responsibilities
- Ensures that Trialwise standard operating procedures are being followed and that appropriate project documentation is ongoing.
- Displays excellent time management, ensuring deadlines of project milestones are accomplished with a strong focus on quality.
- Programs/validates SDTM and ADaM/analysis datasets and TLFs.
- Provides proper documentation in programming/validating.
- Creates the define.xml, annotated CRFs with aid of a senior statistical programmer.
- Supports the biometrics team in developing tools to help automate and simplify work processes within the biometrics area.
- Provides lead programmer with timely and accurate programming status of their assignments.
- Communicates proactively with lead programmer concerning potential changes in scope of work.
Expectations
- Looks for opportunities to expand breadth and depth of statistical programming knowledge computer software, and/or clinical research experience.
- Assists the cross-functional team when possible.
- Maintains a positive outlook and a growth mindset in all work activities.
Salary: $70,000–$85,000 based on experience
Corporate Location
Foster City, CA or US remote-based (home office) with travel as required.
This job description is not designed to cover or contain a comprehensive listing of activities, duties, or responsibilities that are required of the employee. Duties, responsibilities, and activities may change, or new ones may be assigned at any time with or without notice.