JOB POSTING

Senior Director, Statistician, Oncology Clinical Development

ALX Oncology is a publicly traded, clinical-stage immuno-oncology company focused on helping patients fight cancer by developing therapies that block the CD47 checkpoint pathway. Our lead candidate, ALX148, is a next generation CD47 blocking therapeutic that combines a high-affinity CD47 binding domain with an inactivated proprietary Fc domain. ALX148 has demonstrated promising clinical responses across a range of hematologic and solid malignancies in combination with a number of leading anti-cancer agents. 

We are seeking an exceptional candidate who can provide statistical expertise to shape and inform the overall development strategy for the company’s growing oncology portfolio across all phases of clinical development. This position will report to the Vice President of Clinical Development. The individual will collaborate with a multi-disciplined development team encompassing clinical development, regulatory, safety and pharmacovigilance efforts, providing strategic statistical thinking and leadership for the execution of ALX Oncology’s clinical programs in oncology. They will ensure that program and protocol statistical design and statistical analysis plans accurately support clinical strategy. This position will be located in Burlingame, CA, although consideration will be given to exceptional candidates based elsewhere on the West Coast. Domestic and/or International travel may be required up to 20% of work time.

Responsibilities

These may include but are not limited to: 

  • Provide statistical expertise on study design, statistical analysis plans, interpretation and communication of statistical results, project development plans, regulatory issues, and other product support projects.
  • Author statistical analysis plans and statistical sections of protocols.
  • Develop collaborative relationships with stakeholders from research, CMC, clinical pharmacology, external development partners, and business development.
  • Provide planning, delivery, and communication of statistical analyses, data presentations, and scientific reports, including clinical trial results in support of publication activities and product defense.
  • Ensure all study and project level statistical activities are conducted in compliance with relevant regulatory requirements and ALX Oncology standards.
  • Provide statistical input and leadership to cross-functional activities, in collaboration with other statisticians and/or programming colleagues.
  • Contribute to the development of clinical sections of regulatory documents, e.g., Investigators’ Brochures, safety updates, IND/BLA submission documents, responses to Health Authorities questions as needed.
  • Work with CRO data management and clinical teams on data integrity and analyses for study activities as required.

Education, Experience, and Skills

  • Advanced degree in statistics, biostatistics, or related field.
  • Minimum of 10 years clinical research experience in clinical development within a biotechnology and/or pharmaceutical company.
  • Ability to provide statistical leadership to cross-functional teams at both protocol and project levels.
  • Strong statistical skills with application to clinical trials including survival analysis methodology.
  • Expertise in the design, execution, and reporting of late stage clinical trials in oncology with small and/or large molecule drug candidates.
  • Broad understanding of oncology, internal medicine and clinical pharmacology.
  • Excellent working knowledge of FDA and EMA regulations and expectations, GCPs, ICH guidelines, and clinical drug development.
  • Strong communication and collaboration skills.
  • Comfortable with Windows, Outlook, Gmail, Power Point, Word, Excel, and with accessing and working with electronic data capture systems.

ALX Oncology is an equal opportunity employer. All applicants should be legally entitled to work for any employer in the US. Title and salary are commensurate with experience. Our compensation program includes competitive salary, equity participation and attractive bonus incentives.

To apply for this position, please send your cover letter and resume to hr@alxoncology.com