Statistical programmers work collaboratively with internal colleagues and external vendors to ensure the efficient, high-quality production of analysis datasets and statistical outputs for study reports and integrated summaries in support of Gilead’s regulatory, scientific and business objectives.
Locations (2)
Foster City, California, United States
Raleigh, North Carolina, United States
Compensation
The salary range for this position is:
Bay Area: $169,320.00 - $219,120.00.
Raleigh: $146,200.00 - $189,200.00.
Responsibilities
Works collaboratively with Clinical Development staff to meet project deliverables and timelines for statistical data analysis and reporting.
Generates or oversees the production of programming deliverables (e.g., tables, figures, listings) for study reports and integrated summaries.
Anticipates resource needs
Directs the design and/or coding of analysis files.
Ensures programming and corresponding documentation is completed in a manner that is consistent with departmental procedures.
Requirements
BS degree in Biostatistics/Computer Science or equivalent
MS degree in Biostatistics/Computer Science or equivalent
PhD degree in Biostatistics/Computer Sciences or equivalent
Provide end‑to‑end statistical programming support across clinical development programs, leading and performing development and validation of SDTM, ADaM, and TLF datasets, ensuring compliance with CDISC standards and regulatory requirements.
Compensation
The potential base pay range for this role, when annualized, is $98,200.00 - $273,200.00. The actual base pay offered may vary based on a number of factors including job-related qualifications such as knowledge, skills, education, and experience; location; and/or schedule (full or part-time). Dependent on the position offered, incentive plans, bonuses, and/or other forms of compensation may be offered, in addition to a range of health and welfare and/or other benefits.
Responsibilities
Provide end‑to‑end statistical programming support for clinical studies from study setup through submission
Lead and perform development and validation of SDTM datasets
Lead and perform development and validation of ADaM datasets
Lead and perform development and validation of Tables, Listings, and Figures (TLFs)
Ensure all deliverables are compliant with CDISC standards and regulatory requirements
Lead enterprise data governance and data management across NewAmsterdam Pharma’s cloud data platform, establishing standards, policies, and controls to ensure data integrity and regulatory compliance.
Locations (2)
United States
Philadelphia, Pennsylvania, United States
Compensation
We offer a competitive base salary, annual bonus, and long-term incentives.
Responsibilities
Build and run the enterprise data governance and data management function
Develop strategy, policy, and operating processes
Co-chair the Data Governance Council
Establish cross-functional accountability
Design data quality program and domain scorecards
Requirements
Nice to have: designing GxP readiness into a platform
Nice to have: maintaining a validated system in a cloud
Lead statistical programming activities for routine studies, develop SAS programs for ADaM datasets, create documentation for regulatory filings, and produce data visualizations.
Compensation
The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position.
Responsibilities
Lead statistical programming activities for routine studies
Create documentation for regulatory filings including reviewers guides and data definition documents
Participate in the development of standard SAS Macros
Produce dynamic and static data visualizations to communicate quantitative analyses
Develop SAS programs for the creation of ADaM data sets following CDISC standards
Requirements
MS in Statistics, Computer Science or a related field
BS in Statistics, Computer Science or a related field
Nice to have: Support efficacy analyses across clinical development phases and therapeutic areas
Lead statistical programming activities for routine studies, develop SAS programs for ADaM datasets, create documentation for regulatory filings, and produce data visualizations.
Responsibilities
Leads the statistical programming activities for routine studies
Create documentation for regulatory filings including reviewers guides and data definition documents
Participate in the development of standard SAS Macros, as well as, presenting information on existing Macros
Produce dynamic and static data visualizations to communicate quantitative analyses
Develop SAS programs for the creation of ADaM data sets following CDISC standards
Requirements
MS in Statistics, Computer Science or a related field
BS in Statistics, Computer Science or a related field
Nice to have: Support efficacy analyses across clinical development phases and therapeutic areas
Supports delivery of clinical trial data systems, external vendor data acquisition, and fit‑for‑purpose datasets for reporting, analysis, and regulatory submissions.
Locations (2)
Irvine, California, United States
Chicago, Illinois, United States
Responsibilities
Leads external vendor data acquisition for multiple concurrent studies
Ensures study protocol requirements are accurately reflected in clinical system designs
Collaborates extensively with cross‑functional partners
Aggregates clinical trial data into centralized data warehouses
Accounts for timely design and delivery of clinical systems
Requirements
Bachelor's degree
Master's degree
Nice to have: Experience with clinical system design
Provide end‑to‑end statistical programming support across clinical development programs, leading and performing development and validation of SDTM, ADaM, TLFs, and regulatory submission support.
Compensation
The potential base pay range for this role, when annualized, is $98,200.00 - $273,200.00.
Responsibilities
Provide end‑to‑end statistical programming support for clinical studies from study setup through submission
Lead and perform development and validation of SDTM datasets
Lead and perform development and validation of ADaM datasets
Lead and perform development and validation of Tables, Listings, and Figures (TLFs)
Ensure all deliverables are compliant with CDISC standards and regulatory requirements
Requirements
Bachelor’s or Master’s degree in Statistics, Mathematics, Computer Science, Life Sciences, or related field
The Senior Clinical Database Programmer oversees outsourced and in-house database programming activities for global clinical trials, focusing on eCRF design in Medidata Rave and managing CRO responsibilities.
Responsibilities
Lead and monitor the progress of clinical database programming activities with CROs or other vendors
Design eCRF in leading EDC systems such as Medidata Rave
Provide technical support and troubleshooting for Medidata Rave study development
Serve as system administrator for user access via iMedidata Cloud Administration (Rave EDC, Coder, Lab Admin, RTSM, Safety Gateway)
Create Advanced Analytics dashboards
Requirements
BA/BS, preferably in the scientific/healthcare field
Developing and validating R programs for statistical analysis and reporting of clinical trial data.
Leading more than one Statistical Programming team to create, validate and generate statistical outputs, including listings, tables, figures, and CDISC-compliant SDTM and ADaM datasets.
Collaborating with biostatisticians to define analysis plans and statistical methods to be applied to clinical data.
Performing quality control and validation of statistical outputs, ensuring accuracy, consistency, and regulatory compliance.
Assisting in the preparation of statistical reports, presentations, and publications to support regulatory submissions and clinical study reporting.
Requirements
Bachelor's or Master's degree in Statistics, Mathematics, Computer Science, Life Sciences, or a related quantitative field.
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