- Statistical leadership to early and late-stage oncology clinical trials: developing trial design options and providing 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 manager, medical writers and clinical development
- 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
- Apply knowledge of regulatory requirements regarding statistical principles to ensure the company meets its regulatory, scientific, and business objectives
- Develop SOPs for Biostatistics with collaboration with cross-functional teams
- 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 detailed 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 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
- Is expected to 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
- Ability to work within a team as well as independently
- Provide leadership and direction for department strategic initiatives
- Effectively interact with Head of Biometrics, Senior Management and Human Resources to identify and justify resource needs, develop staffing plans, manage recruiting process within Biometrics
- PhD degree in Biostatistics or equivalent with 8+ years (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 developed that influence collaborations with external academic or government organizations to extend visibility or business need of the company
- Effectively uses competitive intelligence to influence clinical development strategies
- Proven effective interpersonal skills to create collaborative relationships within the function as well as with all cross functional organizations
- Hybrid work model acceptable (i.e., part-time in South San Francisco office with flexibility to work part-time from home).
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Director, Biostatistics - South San Francisco, United States - ALX Oncology Inc.
Description
ALX Oncology is a clinical-stage and patient-focused immuno-oncology company developing therapies that block the CD47 myeloid checkpoint pathway. Our lead candidate, evorpacept (ALX148), is a next generation CD47 blocking therapeutic that combines a high-affinity CD47 binding domain with an inactivated proprietary Fc domain. For more information about us, please visitReporting to the Head of Biometrics, the Director of Biostatistics will support oncology drug development, providing statistical leadership and oversight to the development plans, regulatory interactions, and commercial evaluation of investigational compounds in one or more indications. We are seeking an outstanding individual to guide the analytical aspects of our clinical development programs, inform study design, develop and implement novel statistical and computational tools for analyzing trial data, and lead the reporting and analysis of deliverables. The qualified candidate will have a proven track record of functional leadership and mastery of statistics in drug development.
Key Responsibilities and Success Factors:
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.
