ALX Oncology Inc. 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. ALX is headquartered in Burlingame, California.

Reporting to the Head of Biometrics, we are seeking an exceptionally talented individual to provide statistical leadership and oversight for the Company’s lead program, ALX148, involving development plans, regulatory interactions, and commercial evaluation. The ideal candidate will guide the analytical aspects of our clinical development program, inform study design, develop and implement novel statistical and computational tools for analyzing trial data, lead reporting and analysis deliverables, and possess a proven track record of functional leadership and mastery of statistics in drug development. Work will be performed remotely during the pandemic, but this position will be expected to move in-house in Burlingame, CA, when conditions permit.

Key Responsibilities

Serves as statistical leader for early and late-stage oncology clinical trials; develop trial design options and provide high quality decision support.
Provide strategies for clinical study design, endpoint selection, sample size calculation, randomization schedules, statistical analysis plans, and data interpretation in collaboration with all team members including programmers, data managers, medical writers and clinical development staff.
Evaluate and implement innovative designs and novel statistical methodologies as appropriate for clinical studies.
Act as the primary contact and provide oversight for all biometrics related activities outsourced to CROs and external vendors. Work collaboratively with CRO vendors, Clinical Research, Drug Safety, Regulatory, Clinical Operation, and Project Management management/staff to meet project deliverables and timelines for statistical data analysis and reporting.
Applies knowledge of regulatory requirements regarding statistical principles to ensure the company meets its regulatory, scientific, and business objectives.
Collaborates with study investigators, outside experts, and internal colleagues to present and publish trial results and statistical analyses within and outside of the company.
Review data collection strategies and instruments, database design, edit check specifications, external data transfer specifications, and SDTM mapping as needed.
Prepare and/or review in detail the Statistical Analysis Plan (SAP) including development of standardized well-presented mock-up displays for Tables, Listings, and Figures (TLFs), conduct data analyses, and oversee preparation of all TLFs (including review of work by programmers), as well as preparation of the clinical study report.
Create or review programming specifications for analysis datasets and TLFs, including SDTM and ADaM specifications.
Ensure accurate, statistically valid deliverables included in protocols, statistical analysis plans, TLFs, study reports, manuscripts, and regulatory submission documents.
Oversee and contribute to the completion of all technical and operational statistical activities for a group of clinical studies.
Conduct hands-on exploratory analyses, sample size computation, modeling and simulation, and create tools to gain meaningful insights from trial data as needed.
Interpret, summarize, and present data and statistical considerations to internal study team, senior management, advisory boarding meetings and global health authorities.
Develop and maintain all biostatistics related SOPs and guideline documents.
Keep abreast of new developments and advancements in statistics, drug development, science, and regulatory guidance.
Able to effectively work within a team and independently.
Provide leadership and direction for department strategic initiatives.
Work with Head of Biometrics, Senior Management and Human Resources to identify and justify resource needs, develop staffing plans, and support recruiting.
Travel may be required (up to 15%).

Education and Experience

PhD degree in Biostatistics or equivalent with 10+ year (or MS degree with 12+ years) of experience in the statistical analysis of biomedical data using statistical software.
Extensive knowledge of statistical methodology and its application to solve problems in the pharmaceutical/biotechnology industry.
Proven competencies in interaction with health authorities (such as FDA, EMA, PMDA) and eCTD (NDA/BLA) regulatory submissions.
Experience working in a quality regulated environment with a thorough understanding of GCPs.
Extensive hands-on experience in oncology drug development including design and analysis of early and late phase oncology trials.
Excellent programming skills in SAS/R.
Familiarity with industry data standards, including CDISC, SDTM and ADaM data models.
Good understanding of the business beyond the area of Biostatistics and is a recognized authority outside of the company.
Demonstrated effective verbal and written communication skills and interpersonal skills.
Makes effective decisions with limited information.
Ability and interest to work cross functionally.
Has strong networks with external academic or government organizations to extend the visibility or business needs of the company.

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.

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