Principal Statistical Programmer

Redbock - an NES Fircroft company; San Francisco (CA); Presencial; USD 180.000 - 240.000; Jornada completa

Descripción de la vacante

Redbock, an NES Fircroft company, seeks an experienced Statistical Programmer to lead programming and verification of clinical trial data using SAS, ensuring timely, high-quality deliverables and clear communication with statisticians and cross-functional teams.

The role includes producing analysis files, tables, listings, figures, writing analysis specifications, conducting QC, and supporting SDTM/ADaM datasets for regulatory submissions and related documentation.

Formación

• Oncology experience required.
• At least 14+ years of statistical programming experience with clinical trial data using SAS.

Responsabilidades

• Provide Statistical Programming support for SAS scripts and outputs for analysis files, tables, listings, figures and deliverables.
• Ensure accuracy of clinical trial results via QC of documents with clinical data for internal and external audiences.
• Support regulatory submissions and data documentation including SDTM and ADaM datasets.
• Hands-on programming of in-house deliverables and contribution to study-related meetings and publications.

Conocimientos

Statistical programming

Communication

Domain knowledge in clinical trials

Educación

MS or BS/BA in a relevant field

Herramientas

SAS

Descripción del empleo

This position will be responsible for statistical programming and verification of Clinical Trial Data to produce high quality deliverables in a fast-paced environment. This person needs to consistently meet study timelines, quality standards and requirements, and be required to work closely and communicate effectively with internal team members, Statisticians, and other functional group members to best serve the deliverable need.

Responsibilities:

• Provide Statistical Programming support either in the form of production or verification of SAS scripts and outputs for Analysis Files, Tables, listings, Figures, and any other form of Clinical Trial in addition to writing analysis file specifications and other relevant documentation of deliverables and analysis methods.
• Ensure accuracy of clinical trial results for internal and external audiences (e.g., regulatory authorities, academic community, and healthcare providers) via biometrics QC of documents with clinical data.
• Programming support for relevant deliverables, such as Investigator Brochures, publications, US and ex-US regulatory submissions, including CDISC compliant datasets (SDTM, ADaM) and data documentation, Reviewer's Guide, TLFs, Statistical Analysis Plans (study specific, ISS, ISE, Exposure-Response).
• Hands-on programming of in-house deliverables including but not limited to Dose Committee meetings, Board of Director meetings, Exploratory Analysis, etc.

Required Skills, Experience and Education:

• MS, BS/BA degree or other suitable qualification with relevance to the field.
• Oncology experience is required.
• At least 14+ years of statistical programming experience with clinical trial data using SAS software.