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 expertise for the Company’s lead program, ALX148. This position will involve feasibility assessments, development plans, innovative study designs, novel statistical methodology, data collection, statistical analysis, interpretations, and regulatory submissions. 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

Provide statistical support to both 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 and Project 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.
Ensure statistical integrity of analysis and reporting deliverables.
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.
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 Board meetings and global health authorities.
Develop and maintain all biostatistics related SOPs and guideline documents.
Oversee and contribute to the completion of all technical and operational statistical activities for a group of clinical studies.
Keep abreast of new developments and advancements in statistics, drug development, science, and regulatory guidance.
Able to effectively work within a team and independently.
Travel may be required (up to 10%).

Education and Experience

PhD degree in Biostatistics or equivalent with 6+ year (or MS degree with 8+ 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.
Experience working in a quality regulated environment with a thorough understanding of GCPs.
Proven competencies in interaction with health authorities (FDA, EMA, PMDA or other regulatory agencies) and active participation in NDA/BLA filing.
Extensive hands-on experience in oncology drug development including design and analysis of phase 2 and 3 oncology trials.
Strong programming skills in SAS/R.
Familiarity with industry data standards, including CDISC, SDTM and ADaM data models.
Demonstrated written and oral communication skills and ability to work within a team and work independently are required.
Proven ability of analytic thinking skills, building strategic working relationships, and good decision-making capability.

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