Senior Director Biostatistics
South San Francisco, CA
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.
Summary & Scope of Position
This position is responsible for the strategy, planning and implementation of all statistical aspects for the development of products sponsored by Harpoon. This position is responsible for providing statistical input, in partnership with Statistical Programming on protocol development, study design, statistical analysis plans, database development, data review, and data analysis, and will interface with CRO resources. This position also provides support to Regulatory, Translational Medicine, Manufacturing, Business Development, and other areas where biostatistical expertise is required. The successful candidate must have proven technical skills and have demonstrated both strong leadership and highly collaborative abilities.
Provide strategic leadership to the development and maintenance of the Biostatistics functions within Harpoon and provide guidance with Statistical Programming function
Lead the biostatistics staff, including assignments, staffing requirements, prioritization, and budgets.
Define, establish, and document procedures and policies for the Biostatistics department within Clinical Development
Provide statistical expertise and leadership to the development and approval of research compounds, including presenting, negotiating, and defending these results with worldwide regulatory agencies
Contribute to the preparation and review of clinical protocols and statistical analysis plans (SAP) by developing statistical methodology and writing statistical sections including trial design, sample size and power estimates and describing the procedures to be used to analyze the clinical trial for a final clinical study report
Co-author clinical study reports, abstracts, publications, manuscripts, and posters, ensuring that statistical results are accurately interpreted
Interact with FDA, EMA, and other regulatory agencies as appropriate in statistical aspects of study design and data analysis
Collaborate with team to develop standard operating procedures (SOPs) and processes for critical biostatistics, data management, and programming activities
Supervise statistical services outsourced to contract research organizations (CROs), independent contractors, and other vendors
Contribute to clinical development programs and project teams, including input into strategic study design and planning
Develop and implement standards for biostatistics in partnership with programming function including production metrics, protocol statistical sections, SAPs, CRFs, analysis tables, figures, and listings
- Relevant early & late phase oncology and/or immune-oncology experience required
- Demonstrated strategic and critical thinking
- Excellent communication skills (verbal and written) and excellent organizational skills
- Detail oriented with a dedication to quality and reliability
- Demonstrated sense of urgency and accountability for both individual and team-owned work products with the ability to work on multiple tasks in a fast-paced, entrepreneurial environment
- Thorough knowledge of FDA and worldwide regulatory requirements and ICH/GCP guidelines
- 12+ years relevant experience managing a biostatistics group within clinical research in the
- pharmaceutical, biotechnology, or CRO industry, preferably with oncology products
- MS or Ph.D in biostatistics or statistics, or equivalent
Harpoon anticipates that the annual base salary for this position could range from between $235,000.00 – $270,000.00 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.