Poseida Therapeutics, Inc. is seeking a talented Senior Manager/Associate Director of Statistical Programming to join our team in San Diego, CA. This position offers an excellent opportunity for a highly motivated individual to contribute to innovative clinical trials for new CAR-T, gene editing and gene therapy products in an exciting and dynamic environment focused on cutting-edge gene editing technology. The Senior Manager/Associate Director, of Statistical Programming will provide statistical programming support for the Biometrics team in support of multiple clinical studies, biomarker data and manufacturing data which includes internal requests, safety reports, manuscripts, posters, presentations, etc. The position will also oversee the CRO delivery to ensure high quality output.
These may include but are not limited to:
- Function as lead programmer on multiple projects by performing all SAS programming requirements for the project, overseeing the work of external vendors (CROs), supporting programming needs of Data Management and act as Lead Biostatistical Programmer interacting with the Lead Biostatistician
- Create or review and approve CDISC compliant datasets and corresponding documentation for electronic submission to regulatory agencies
- Perform quality control checks the SAS program and output produced by other statistical programmers and external vendors
- Developing SAS programs for study related ad hoc requests, presentations, posters, etc.
- Provide technical expertise to the development of programming standards and procedures
- Assists Data Management with SAS programming needs
- Develop Programming department and provide training and performance management of staff
- Assists in developing SOPs
Requirements, Knowledge, Skills and Abilities
- Master’s Degree preferred or Bachelor’s Degree with equivalent years of work experience in Biostatistics, Mathematics, Statistics, Computer Science or Life Sciences.
- Minimum 8+ years in the biotech, pharmaceutical or CRO setting
- Experience programming on oncology clinical trials.
- Experience programming for chimeric antigen receptor cell (CAR-T) trials preferred
- Understand and able to implement CDISC standards and transform raw data to these standards
- Highly competent in SAS programming and Macro development
- Demonstrated working knowledge of data processing, database design and organization in clinical data environment
- Experience with NDAs/BLAs
- Demonstrated out of the box problem-solving and critical thinking skills
- Demonstrated ability to work independently and effectively in a dynamic, complex and fast-paced team environment
- Experience working with JMP, JMP Clinical and/or Spotfire or other similar platforms preferred
- Management experience preferred
- Travel may be required up to 5% of the time.
Who We Are and What We Do
Poseida is a San Diego based biotechnology leader in the development of cell and gene therapies. We have built a wholly-owned pipeline of autologous and allogeneic chimeric antigen receptor T cell, or CAR-T, product candidates, initially focused on the treatment of hematological malignancies and solid tumors. Here at Poseida we are constantly innovating and growing as we advance our CAR-T therapies in the clinic and our gene therapies currently under development. The Poseida team is passionate about the impact we are making in developing treatments, or even cures, for patients with cancer or other genetic diseases.
The company’s CAR-T product candidates are manufactured with Poseida’s non-viral piggyBac® DNA Modification System, resulting in a high percentage of stem cell memory T cells (TSCM). Tscm cells are the only T cells that are self-renewing and long-lived, potentially resulting in product candidates that are more efficacious, less toxic and more durable. Poseida is currently developing the following CAR-T product candidates:
- P-BCMA-101 is an autologous CAR-T therapy for the treatment of relapsed/refractory multiple myeloma, currently enrolling patients for a Phase 2 registrational trial with initial dosing expected in the first half of 2019.
- P-PSMA-101 is an autologous CAR-T product candidate targeting PSMA-specific cancer cells in castrate resistant prostate cancer, with filing of an IND anticipated in the second half of 2019.
- P-BCMA-ALLO1 is an allogeneic, or universal donor, CAR-T product candidate, manufactured using Poseida’s proprietary Cas-CLOVER™ site specific gene editing system and is being developed as a treatment for relapsed/refractory multiple myeloma, with an IND filing anticipated by late 2019 or early 2020.
- P-MUC1C-101 is an autologous CAR-T product candidate in late-stage preclinical development for numerous solid tumor indications, including ovarian, breast, lung, colorectal, pancreatic and renal cancers, with filing of an IND anticipated in 2020.
Poseida plans to broadly advance its current CAR-T programs and emerging pipeline programs, including gene therapies for orphan genetic diseases.
To apply send your resume and cover letter to email@example.com.