Senior Statistical Programmer
We are Rakuten Aspyrian Inc., a privately funded, clinical stage, Biotechnology Company headquartered in San Diego, California. We are focused on advancing innovative science into breakthrough products that provide cancer patients with new treatments to conquer their disease.
We are supported by investors that have the commitment to build a long-term company that integrates research, development and commercialization of cutting edge cancer therapies with the aim to transform cancer treatments. Our mission is “CONQUERING Cancer. For LIFE.”
We are developing therapies based on a novel proprietary technology platform that utilizes antibodies conjugated with payloads that are specifically activated at the tumor site. Our first clinical product will advance into Phase 3 pivotal clinical testing to treat terminal cancer patients. This is a first-in-class product with unique pharmacological activity and with the potential to have a broad impact in cancer. Given the rapid progression of the clinical studies we are quickly expanding the team to support late stage pivotal clinical development and future commercialization of our products.
The Senior Statistical Programmer is responsible for providing timely support to clinical study teams on all programming matters (simple to complex) related to processing data from clinical studies. You will play a key role in developing, implementing, and evaluating statistical programming standards and processes. This role will function as the lead programmer on assigned studies, phase I to IV. The Senior Statistical Programmer will create, document, and validate corresponding related SAS programs, datasets, and outputs needed for the analysis, interpretation, and monitoring of clinical trials. You will also hold responsibilities for maintenance and management of the departmental program codes, documentations, and output as they are developed. The Senior Statistical Programmer will respond to both planned and ad-hoc data requests from the clinical team. You will participate actively in project teams. The Senior Statistical Programmer will interact with both internal parties and external study vendors, acting as a representative of Clinical Programming.
Key Duties and Responsibilities
As the Senior Statistical Programmer, you will work closely with colleagues (Medical, Clinical Scientists, Statisticians, Project Management, Medical Writing, Safety, Clinical Operations, Regulatory, and Data Management teams) as well as external CRO partners to:
- Oversee CROs, vendors, and consultants for the statistical programming deliverables, while ensuring consistency of approach for all studies assigned to CROs; review their adherence to timelines, as well as quality and cost.
- Consult in the design and development of clinical trials to ensure compliance with regulatory requirements, sponsor and CRO SOPs and working practice documents.
- Review study and project related documents that require statistical programming input, including the protocol, CRF and database design, SAP, SPP (statistical programming plan), and 3rd party data transfer specifications.
- Responsible for the generation of study deliverables and being the Clinical Programming point of contact for other functions.
- Retrieve clinical data and metadata from EDC systems and create SAS datasets; create SAS datasets from other systems data as well (IWRs, Labs, Imaging, etc.).
- Develop, validate, and document programs, SAS Macros, and systems used.
- Program TLFs needed for analyses and reporting, including for CSRs, DSURs, IB, DSMBs, etc.
- Fulfill ad-hoc requests in support of data collection/cleaning/data presentations/ or analyses.
- Review CDISC specifications and output for SDTM and ADaM datasets as well as define.xml, reviewers guide documents and Pinnacle 21 validation reports for a clinical study. Create ADaM specifications when needed.
- Review and provide feedback on the output SAS datasets from the database to ensure that the clinical database and the data collected are complete and, in a format, conducive to efficient and error-free SAS programming.
- Keep abreast of biopharmaceutical trends and best practices in the use of SAS as well as discuss technical and software concepts with the clinical group.
- Participate in standardization efforts.
- Maintain effective and efficient communication both within the Clinical Programming group and Biometrics, as well as with the other functional groups.
- Contribute to or develop programming and quality standards, SOPs and WPs.
- Present to internal audiences on study-specific issues and processes.
- Solve problems proactively and determine when and how to escalate issues.
- Keep manager informed of progress and any issues that may impact process compliance, data integrity, reporting accuracy, long term efficiency, timelines, or quality.
- Perform other functions as necessary or assigned.
Desired Education, Skills and Experience
- Bachelor’s degree in a scientific discipline, Mathematics, Statistics or Computer Science Experience required. Master’s degree preferred.
- A minimum of 5 years of SAS programming experience required.
- A minimum of 2 years of clinical trials experience required.
- Experience with oncology clinical trials preferred.
- Experience in BLA/NDA Submission and/or interactions with the regulatory requests is preferred.
- Must be familiar with FDA and ICH guidance and regulations as they relate to statistical programming, 21CFR Part 11, E9, good programming practices and software validationmethods.
- Experience with working with CRO’s, vendors, or consultants preferred.
- Must have advanced experience with SAS Base.
- Must be proficient in SAS MACRO language, ODS.
- Experience with SAS/STAT, SAS/Graph required.
- Experience with SAS JMP and/or SAS JMP Clinical preferred.
- Experience with CDISC STDM and ADaM required.
- Experience performing a leadership role in project teams preferred.
- Must have demonstrated ability to support multiple difficult assignments with challenging timelines.
- Must have excellent verbal and written communication skills.
We are proud to offer a competitive compensation plan with an excellent benefits package including flexible time off, stock options, 401k, medical, dental, vision plans and more.
Rakuten Aspyrian Inc. is proud to be an Equal Opportunity Employer. We celebrate diversity and are committed to building a team that represents a variety of backgrounds, perspectives and skills.