Director, Biostatistics

Director, Biostatistics

Reporting to the Vice President, Biometrics, the Director, Biostatistics will serve as a project-level biostatistician and provide leadership within biostatistics function to develop and execute statistical strategy, study design, statistical analyses, and regulatory submissions for clinical trials in oncology. Partners with clinical science, regulatory and other team members in clinical development plans, authoring key clinical/regulatory/statistical documents, and ensuring exceptional delivery and interpretation of clinical data. Develops and implements biostatistics department policies, standards, procedures, and work-instructions in collaboration with department leadership and cross-functional teams. Represents biostatistics function in interactions with CROs, institutional review boards, and global regulatory authorities.

Essential Job Functions and Responsibilities:

• Provide strategic and technical leadership in biostatistics to support oncology clinical development programs and study execution
• Contribute to protocol development, ensure appropriate trial design, sample size determination, and efficient statistical methodologies
• Lead development of statistical analysis plans, data presentation plans, and biometrics components of clinical and regulatory strategies
• Review the accuracy of clinical data, perform statistical analysis, interpret study results, and collaborate with clinical team and other team members to produce interim reports, final reports, and publications
• Write/review sections of meeting packages and assist in the development and review of other documents required for regulatory submissions and other regulatory processes
• Provide oversight of SDTM/ADaM specifications, TLFs, and vendor data transfer specifications to ensure quality and compliance
• Represent biostatistics function or biometrics department in cross function teams
• Work with department head to develop and implement department policies, standards and procedures
• Partner with clinical operations, data management and CRO to develop and implement CRFs, database design, and the overall data quality plan
• Evaluate and manage CROs and other vendors, including scope-of-work, timelines, deliverables and budgets
• Provide strategic statistical and regulatory guidance to anticipate challenges, mitigate risk, and ensure project success
• Participate in FDA and other health authorities to interactions to align on development strategies

Preferred Qualifications:

• Master's degree in statistics or biostatistics required, or a related area degree preferred (e.g., MS) with 10+ years of progressive clinical trial, or healthcare experience in the life sciences industry or an equivalent combination of academic and industry experience
• Technical expertise and knowledge of experimental design and analyses using SAS; Experience with R helpful
• In-depth knowledge of CDISC standards
• Solid working knowledge of ICH, FDA and GCP regulations and guidelines
• Experience in supporting oncology phase 1/2/3 clinical trials
• Excellent communication and interpersonal skills, with the ability to collaborate effectively with internal and external stakeholders
• Strong analytical and problem-solving abilities
• This position requires periodic/regular travel which may include overnight travel

Physical Demands and Work Environment:

Physical Demands:

• Constant or continuous use of a computer keyboard, monitor, and mouse to perform a variety of tasks
• Constant or frequent sitting, standing, or walking
• May lift and/or move objects of various weights

Work Environment:

• Remote: Home office; expected to travel to and work from the Company's headquarters in San Diego from time to time
• San Diego-based: On-site requirement (Monday through Thursday)
• Noise level in the work environment is usually moderate
• Fast-paced, time sensitive environment with frequently changing priorities
• Handle multiple projects simultaneously

Reasonable accommodation may be provided to enable qualified individuals with disabilities to perform the essential functions of the position.

Salary Range:

The salary range for this position is $235,000 to $248,000 per year. The final pay offered to a successful candidate will be dependent on several factors that may include, but are not limited to, the type and years of experience within the job and the industry, education, and skills and certifications.

Benefits:

Provided they meet all eligibility requirements under the applicable plan documents, employees (and their eligible dependents) will be eligible to enroll in group healthcare plans that offer medical, dental, vision, and basic life and AD&D insurance. Additional benefit programs include short-term and long-term disability insurance, flexible spending accounts, health savings accounts, and voluntary insurance programs, including voluntary life, AD&D accident, and critical illness. Employees will also be able to enroll in the Company's 401(k) plan. In addition, employees will accrue 10 hours of paid vacation time every month and accrue 1 hour of paid sick leave for every 30 hours worked. Employees also enjoy 17 paid holidays each calendar year, including a winter closure, subject to applicable Company policies. All benefits are subject to the terms and conditions of the applicable plan documents and Company policies, which may be amended from time to time.

Other Compensation:

The hired candidate will be eligible to receive an annual discretionary bonus and an equity award, subject to the terms of the applicable employment agreement, plan documents, and Company policies.

Applications for this position are anticipated to close on Aug 31, 2026. For more information about this posting, please contact View email address on click.appcast.io.

Equal Employment Opportunity:

Avenzo is committed to providing equal employment opportunities to all employees and applicants without regard to an individual's actual or perceived protected characteristic or characteristics, or any combination of protected characteristics including race (including traits associated with race, such as hair texture and protective hairstyles, including braids, locks, and twists), ethnicity, religion, religious creed (including religious dress and grooming practices), color, sex (including childbirth, breast feeding, and related medical conditions), gender, gender identity or expression, sexual orientation, national origin, ancestry, citizenship status, uniformed service member and veteran status, marital status, pregnancy, age (40 and over), protected medical condition (including cancer and genetic conditions), genetic information, disability (mental and physical), reproductive health decision-making, medical leave or other types of protected leave (requesting or approved for leave under the Family and Medical Leave Act or the California Family Rights Act), the employee or their family member's status as a victim of a qualifying act of violence, political activity or affiliation, use of cannabis off the job and away from the workplace, association with an individual who has, or is perceived to have, a protected characteristic or characteristics, or any combination of protected characteristics, or any other protected status in accordance with all applicable federal, state, and local laws.

Notice to Search Firms/Third Party Agencies:

Avenzo does not accept unsolicited resumes from recruiters, employment agencies or search firms without a valid, executed search agreement in place.