Associate Director Biostatistics (Temporary)

Aligos Therapeutics•South San Francisco, CA

1d•$110 - $120•Hybrid

About The Position

The role provides subject matter expertise for the statistical design, analysis, and interpretation of clinical trial data. This role reports to Head of Biostatistics and works closely with cross functional teams including clinical operations, data management, medical writing, and regulatory affairs to ensure the integrity, accuracy, and scientific rigor of statistical analyses across multiple studies. They contribute to the strategic planning of study design and provide guidance on statistical methodology, data analysis and reporting to support late-stage clinical development programs. Ideally, the person hired for this role will work out of our South San Francisco, CA office however remote candidates will also be considered.

Requirements

Master's degree in biostatistics, statistics or a related scientific discipline or PhD in Biostatistics, Statistics, Mathematics, Epidemiology, or a related scientific discipline.
3+ years proven experience in late-stage clinical trial design (phase 2 and/or phase 3), statistical programming, and data analysis.
4-6 years’ experience working with a team of statistical programmers.
4-6 years’ strong knowledge of statistical software such as SAS, R, or Python
4-6 years’ familiarity with regulatory requirements and guidance from FDA, EMA, or other health authorities.
4-6 years’ experience with global clinical trials and multi-center studies.
Ability to adapt quickly, succeed in a team environment and learn new tasks independently.
Excellent interpersonal and communications skills, ability to build productive internal/external working relationships with cross-functional teams.
The successful candidate must be flexible and adaptable to the needs of a small company.
All candidates are expected to have authorization to work in the United States.

Responsibilities

Lead and oversee the statistical analysis plan SAP development, study design, and protocol development in collaboration with cross functional teams.
Provide statistical input for study protocols, case report form CRF design, and data collection strategies.
Ensure high-quality statistical deliverables, including SDTM, ADAM, specifications, data reviewer guides, tables, listings, figures, and clinical study reports.
Conduct complex statistical analyses using appropriate methodologies for clinical trials.
Review and approve statistical outputs, results, and programming code generated by team members.
Collaborate with medical writing, regulatory, and clinical teams to ensure accuracy and clarity of statistical content in submissions.
Support regulatory submissions and respond to queries from health authorities regarding statistical analyses.
Provide strategic input for study design, sample size calculations, and adaptive trial methodologies.
Participate in department and corporate initiatives, including SOP development, quality assurance, and methodological advancements.
Perform other duties as assigned.
Comply with all policies and standards.