Careers

Sr/Director Statistical Programming

Harpoon Therapeutics is a clinical-stage immunotherapy company located in South San Francisco. Harpoon Therapeutics 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. 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 small cell lung cancer and other DLL3-associated tumors. Harpoon has also developed a proprietary ProTriTAC™ platform, which applies a prodrug concept to its TriTAC platform to create a therapeutic T cell engager that remains inactive until it reaches the tumor. The company’s third proprietary technology platform, extended release TriTAC-XR, is designed to mitigate cytokine release syndrome. 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.

Position Overview

The Director of Statistical Programming will oversee all Statistical Programming activities supporting multiple drug development programs. This position requires a comprehensive knowledge of SAS and CDISC standards, regulatory filing experience, and a broad understanding of the pharmaceutical drug development process.

Professional Responsibilities

  • Lead a Statistical Programming department focused on data integrity, collaboration and on-time deliverables
  • Manage and provide oversight of Statistical Programming FTEs, contractors and CROs
  • Oversee the development and implementation of Statistical Programming SOPs and work instructions
  • Develop and maintain CDISC-compliant and submission-ready SAS programs, SDTM, ADaM and summary tables and figures
  • Partner with the many functions of Clinical Development and provide programming support as necessary
  • Review and support the development of SAP, Protocol, CRF design and edit-check specifications
  • Monitor and evaluate ongoing clinical trial data and contribute to the resolution of data discrepancies
  • Develop and maintain standard reporting templates
  • Acquire necessary tools to improve programming efficiency and facilitate review of clinical trial data
  • Ensure programming infrastructure supports integrated summaries (ISE/ISS), CSR, conferences/publications, ad-hoc analyses and regulatory deliverables
  • Oversee Statistical Programming department budget and requirements
  • Ensure proper filing of study documentation, regulatory compliance and inspection readiness

Education/Experience

  • Bachelor/Master’s degree in Statistics, Mathematics, Computer Sciences or other closely-related field with a minimum 15 years Pharmaceutical/Biotech programming experience with 7+ years of management experience
  • Experience in the analysis of complex oncology clinical trial data
  • Regulatory filing experience

Professional Requirements

  • Mastery of SAS programming concepts relevant to the pharmaceutical industry
  • Extensive knowledge of CDISC SDTM and ADaM data models

Personal Characteristics

  • Extensive experience managing FTEs, Contractors and CROs
  • Excellent written and interpersonal communication skills
  • Ability to effectively manage multiple projects concurrently and meet time-sensitive deliverables

Harpoon anticipates that the annual base salary for this position could range from between $235,000.00 - $250,000.00 and will depend, in part, on the successful candidate’s credentials for the role, including education, qualifications, and type as well as length of experience. Any offered salary is also based on internal equity, internal salary ranges, market data, and the position’s wage range. The salary range listed does not include any applicable bonuses or long-term incentives, differential pay or other forms of compensation or benefits. Harpoon is a multistate employer and the salary offered will be market competitive. At Harpoon, it is not typical for an individual to be hired at or near the top of the range for their role and compensation decisions are dependent on the facts and circumstances of each case.