Senior Manager, Statistical Programming
Harpoon Therapeutics (ticker: HARP) is a clinical-stage immunotherapy company developing a novel class of T cell engagers that harness the power of the body’s immune system to treat patients suffering from cancer and other diseases. T cell engagers are engineered proteins that direct a patient’s own T cells to kill target cells that express specific proteins, or antigens, carried by the target cells. Using its proprietary Tri-specific T cell Activating Construct (TriTAC®) platform, Harpoon is developing a pipeline of novel TriTACs initially focused on the treatment of solid tumors and hematologic malignancies. HPN424 targets PSMA and is in a Phase 1/2a trial for metastatic castration-resistant prostate cancer. HPN536 targets mesothelin and is in a Phase 1/2a trial for cancers expressing mesothelin, initially focused on ovarian and pancreatic cancers. HPN217 targets BCMA and is in a Phase 1/2 trial for relapsed, refractory multiple myeloma. HPN328 targets DLL3 and is in a Phase 1/2 trial for cancers expressing DLL3, initially focused on small cell lung cancer and other tumors with high-grade neuroendocrine features. Harpoon is led by an experienced management team. The company emphasizes a collegial, collaborative environment and has a strong record of scientific innovation, pioneering protein engineering, expertise in tumor immunology and pre-clinical and clinical research. For additional information about Harpoon Therapeutics, please visit www.harpoontx.com.
We are seeking a highly motivated individual to serve as the Senior Manager of Statistical Programming at Harpoon. This individual will report into the Head of Statistical Programming and will oversee Statistical Programming activities supporting multiple clinical studies.
This position requires a comprehensive knowledge of SAS and CDISC standards and a broad understanding of the pharmaceutical drug development process. Project-level responsibilities include the oversight and management of workflows in the generation of clinical data listings, summary tables and graphical output.
- Manage and oversee statistical programming vendors
- Lead statistical programming activities for one or more projects
- Represent the statistical programming department in study team meetings
- Develop and oversee implementation of CDISC SDTM and ADaM datasets
- Review and support the development of SAP, Protocol, CRF design and edit-check specifications
- Ensure data quality through the monitoring of ongoing clinical trial data and identification of data inconsistencies
- Interact with cross-functional personnel, including Statistics, Data Management and Clinical
- Perform pre-defined and ad hoc data analyses to support the evolving needs of the project team
- Develop tools to improve programming efficiency, primarily in SAS
- Monitor clinical data workflow, including raw EDC extracts and outside vendor data
- Manage project timelines for statistical programming deliverables
Skills and Qualifications
- Bachelor/Master’s degree in Statistics, Mathematics, Computer Sciences or other closely-related field with at least 7 years of Pharmaceutical/Biotech programming experience and 2+ years of management/supervisory experience
- Experience in the analysis of complex oncology clinical trial data
- Regulatory filing experience a plus
- Expertise in SAS programming concepts relevant to the pharmaceutical industry
- Extensive knowledge of CDISC SDTM and ADaM data models
- Experience managing FTEs, Contractors and CROs
- Excellent written and interpersonal communication skills
- Ability to effectively manage multiple projects concurrently and meet time-sensitive deliverables