Sr. Director, Biostatistics

Valid8 Financial, Inc.; South San Francisco (CA); On-site; USD 240,000 - 280,000; Full time

Benefits offered by this job

Equity participation

Attractive bonus incentives

Flexible working models

Job summary

ALX Oncology in South San Francisco seeks a Senior Director of Biostatistics to lead statistical strategy across oncology programs, with emphasis on Phase 3 registrational studies, adaptive designs, and CDx development.

You will guide protocols, SAPs, CSRs, and regulatory submissions, mentor statisticians and CROs, and drive methodological innovation while aligning with global regulators and business goals.

Qualifications

• PhD or MS in Biostatistics, Statistics or related quantitative discipline.
• Proven leadership in Phase 3 registrational oncology trials.
• Expertise in adaptive trial designs and CDx co-development.
• Experience with global regulatory submissions and health authority interactions.
• Strong SAS and R proficiency; experience with EAST/ADDPLAN is a plus.

Responsibilities

• Provide strategic statistical leadership for oncology programs from early development through registration.
• Design and execute Phase 1–3 oncology trials, emphasizing registrational Phase 3.
• Develop innovative adaptive designs and simulation-based evaluation.
• Guide SAPs, CSRs, regulatory briefing packs, and publications.
• Mentor statisticians and CROs; support regulatory meetings and submissions.
• Ensure ICH/FDA/EMA compliance and cross-functional collaboration.

Skills

Strategic leadership

Adaptive trial design

Regulatory interactions

Communication

Biostatistics expertise

Clinical development

Education

PhD in Biostatistics

MS in Biostatistics

Tools

SAS

R

EAST

ADDPLAN

Job description

We are seeking an experienced and strategic Senior Director of Biostatistics to provide statistical leadership across oncology clinical development programs, demonstrating strong expertise in Phase 3 registrational studies, adaptive trial design, and companion diagnostic (CDx) development.

Key Responsibilities

• Provide strategic statistical leadership for oncology programs from early development through registration and lifecycle management.
• Lead the design and execution of Phase 1–3 oncology clinical trials, with emphasis on registrational Phase 3 studies.
• Develop innovative and efficient clinical trial designs, including basket, umbrella, and platform trials.
• Provide statistical guidance on endpoint selection, multiplicity control, estimand strategy, and sensitivity analyses.
• Contribute to protocols, statistical analysis plans (SAPs), clinical study reports (CSRs), regulatory briefing packages, publications, and scientific presentations.
• Lead development and evaluation of adaptive design methodologies using simulation‑based approaches, evaluating operating characteristics, power, futility and efficacy boundaries.
• Partner with programming teams to develop simulation frameworks in R and/or SAS.
• Communicate complex adaptive design concepts to cross‑functional teams and regulatory agencies.
• Lead statistical support for regulatory meetings and submissions (e.g., End‑of‑Phase 2, Type B, NDA/BLA).
• Provide strategic input on alpha allocation, multiplicity adjustment, interim/final data analyses, IDMC/DMC support and benefit‑risk assessments.
• Ensure compliance with ICH, FDA, EMA and global regulatory guidance for therapeutics and diagnostics.
• Serve as a core member of oncology program teams, mentor statisticians and programmers, and oversee CROs and external vendors.
• Drive adoption of statistical standards, innovative methodologies and data quality best practices.
• Support business development, due diligence and portfolio strategy activities.

Qualifications

• PhD or MS in Biostatistics, Statistics or a related quantitative discipline (PhD strongly preferred).
• Typically: 12 + years of biotech/pharma industry experience for PhD holders, or 15 + years for MS holders.
• Extensive oncology drug development experience with demonstrated leadership in Phase 3 registrational oncology trials.
• Strong experience with adaptive trial designs, simulation methodologies and companion diagnostic co‑development.
• Prior experience with global regulatory submissions and health authority interactions.
• Biotech industry experience strongly preferred.
• Technical expertise in oncology clinical trial methodology, survival analysis, multiplicity adjustment, group sequential and adaptive methodologies, Bayesian and frequentist approaches, biomarker‑driven development, estimands framework, missing data methodology, interim monitoring, IDMC support and companion diagnostic statistical methods.
• Proficiency in SAS, R and preferred adaptive design software such as EAST or ADDPLAN.
• Strategic, innovative thinker with strong scientific judgment, excellent communication, stakeholder management skills and proven ability to lead in a fast‑paced biotech environment.

Preferred Experience

• Immuno‑oncology and targeted therapy development.
• Companion diagnostic co‑development and PMA support.
• Precision medicine and biomarker‑enriched development programs.
• Global multi‑regional clinical trials and accelerated approval pathways.

Salary & Benefits

Salary range: $240,000 – $280,000 DOE.

We offer flexible working models, competitive benefits, equity participation and attractive bonus incentives.

Physical Demands

• Ability to communicate in written and oral forms.
• Communicate with a diverse group of individuals on technical and business topics.
• Perform tasks that require sitting, standing, kneeling, stooping, walking and using hands to finger, handle and reach.
• Travel 25 % of the time domestically and/or internationally.
• Use the telephone and communicate clearly with external individuals.
• Work at a computer for extended periods.
• Manage multiple tasks in a fast‑paced working environment.

Work Environment & Conditions

We offer flexible working models, competitive benefits, equity participation and attractive bonus incentives.

Equal Opportunity Employer

ALX Oncology is an equal‑opportunity employer; hiring decisions are made without regard to race, color, religion, gender, sexual orientation, gender identity/expression, national origin, ancestry, age, disability, marital status or veteran status. Reasonable accommodation will be provided for qualified individuals with disabilities and for disabled veterans as required by law.

Disclaimer

The above description is intended to describe the general nature of the job and may include other duties as performed or assigned; it is not intended to be all inclusive or limit the duties of the position.