Senior Clinical Programmer – 6 month contract

Job Title: Senior Clinical Programmer – 6 month contract

Job Number: 84572

Location: Hayward, US

Job Description

The Clinical Programmer will provide support for data review, reconciliation, and edit checks, as well as programming submission-ready SDTM deliverables. Reporting to a senior member of the Clinical Programming team, this role involves regular interaction with internal and external biostatisticians, data managers, and other key team members. Strong communication skills, the ability to prioritize tasks, and effective collaboration with stakeholders across departments such as Biometrics, research, clinical operations, and regulatory are essential. This is an exciting opportunity to join a growing Biometrics team focused on early-stage immuno-oncology therapeutics. The ideal candidate will bring extensive industry experience in a regulated global setting, combined with the flexibility and scientific insight to contribute to building internal processes, establishing analysis standards, and supporting both formal and exploratory initiatives.

Responsibilities

* Build and execute programs for data reviews, reconciliation, and edit checks based on specifications from Data Management.   * Assist in developing and maintaining programming standards and tools. * Review documentation such as case report forms and database specifications in coordination with Data Management. * Develop specifications for data transfers and oversee the transfer of external data with some support. * Program datasets and produce deliverables such as data collection forms and metadata files. * Manage relationships with stakeholders, ensuring alignment on timelines and deliverables with minimal supervision. * Contribute to the development of standards and operational processes within the department.

Required Skills

* Bachelor’s or Master’s degree in a relevant field such as statistics, mathematics, computer science, or bioinformatics, or equivalent experience.   * At least 4 years of experience in the biotechnology or pharmaceutical industry, with a preference for oncology experience. * Proficiency in SAS programming; experience with additional languages (e.g., R) in regulated environments is a plus. * Understanding of data standards, including CDISC formats. * Experience handling various data types, including biomarkers and clinical data. * Ability to adapt to changing project and strategic needs. * Practical approach to both daily tasks and long-term objectives. * This role can be based at our preferred locations in Hayward or Brisbane, CA, or may be performed remotely.

Application Deadline: 2024-11-04