– 12 month renewable contract
– Onsite San Diego
- Provide programming support to multiple oncology studies, provide input to timeline development
- Create/review programming plan, specifications for datasets and TLFs; knowledgeable with CDISC standard i.e., SDTM and ADaM models and experienced in implementing these models.
- Develop and validate SAS programs to produce high quality deliverables for in-house projects within set timelines in accordance with company and regulatory requirements. The deliverables include SDTM and ADaM datasets, define.xml, tables, listings and figures.
- Perform conformance checking of SDTM and ADaM datasets using Pinnacle 21; recommend/implement solutions to identified issues; ensure datasets are in compliance with submission standards
- Review and validate deliverables produced by CROs, provide solutions to issues raised by CROs
- Create/review analysis file specification for ISS and ISE; program and validate ISS and ISE.
- Having advanced level of programming expertise, create and validate SAS macros and utilities to automate frequent tasks
- Create/oversee the creation of proper documentation related to statistical programs, datasets, review guides and QC documentation, ensure documentations are in compliance with SOPs and/or meeting submission requirements.
- Review and provide input on documents produced by other biostatistics functions such as: statistical analysis plans; TFL shells; data management plans; data transfer plans and case report forms.
- Effectively communicate in a team environment, within department and among functional groups
- Perform other programming duties as assigned
What would a successful candidate look like?
- Minimum of BS required in Computer Science, Statistics, Life Sciences or other related field
- SAS programming experience in drug development in CRO or pharma/biotech company is preferred; experience with R language is a plus
- Good written and verbal communication skills.
- Oncology experience preferred, and submission experience is a plus