Based in South San Francisco, California, Onyx Pharmaceuticals is an Amgen subsidiary, engaged in the development and commercialization of innovative therapies for improving the lives of people with cancer. At Onyx, our success begins with our employees. The progress we have made as a company reflects the talents of the individuals who have come together to develop possible new therapeutics for treating cancer.
Onyx is seeking talented and dedicated individuals of the highest caliber who are passionate about the pharmaceutical industry and driven to change the way cancer is treated. We are proud to be an equal opportunity employer who respects individual differences and recognizes each employee as an integral member of our company. Our culture is one where everyone can learn and develop personally and professionally.
Provides clinical programming support for assigned studies under the guidance of a supervisor. Responsible for program listing and reports. Responsible for performing system setup and/or User Acceptance Testing following standard process procedure and SOP.
* Responsible for program data review listing, reports (including patient profiles) and Study Quality Metrics
* Responsible for program and execution of ad hoc requests, and other reports under supervision as required
* Responsible for setting up external data transfer specifications with CROs and Vendors. , scheduling and performing data transfers between Onyx and CRO and/or vendors. ,generating reconciliation programs to ensuing consistencies between clinical and external databases under supervision
* Responsible for generation of the program specifications under supervision as required
* Ensures timely completion of tasks assigned with quality
* Identifies areas of deficiency requiring SOPs or guidelines
* Follows guidelines and specifications on validation procedures and data transfer procedures. Maintain appropriate documentation surrounding maintaining or archiving clinical data and/or programs.
* Works directly with CRO used for data management and/or clinical programming under supervision
Bachelor in Computer Sciences, Mathematics, Life Sciences with a minimum of 1+ years of clinical programming experience in the pharmaceutical or biotechnology industry
* Clinical programmer experience in a pharmaceutical or CRO working in a FDA regulated environment
* Oncology experience preferred
* Experience in performing programming to support project needs
* Good working knowledge of ICH, FDA, and GCP regulations and guidelines; Strong well-rounded technical skill using SAS
* Committed to learning scientific background and understanding of clinical trials, pharmaceutical operations, and regulatory compliance
Amgen is an Equal Opportunity/Affirmative Action employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, national origin, protected veteran status, or disability status.