[Hiring] Associate Director Biostatistics @Aligos Therapeutics

Role Description

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.

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.
• Reasonable accommodations may be made to enable individuals with disabilities to perform these essential functions.

Qualifications

• 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.

Additional Eligibility Qualifications/Competencies

• 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.

Work Authorization/Security Clearance

• All candidates are expected to have authorization to work in the United States.

Position Type and Expected Hours of Work

• This is a temporary, part-time position requiring approximately 20–25 hours per week for an initial 12-month period.

Physical Requirements

• It is expected that the contractor is able to sit/stand at a desk and have full use of a computer through its standard input devices (e.g., mouse and keyboard).

Travel

• If hired remotely, periodic travel to our office in South San Francisco, CA will be required.

Other Duties

• Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties, or responsibilities that are required of the contractor for their job. Duties, responsibilities, and activities may change at any time with or without notice.

Work Environment

• This position is ideally located onsite in our South San Francisco, CA office, but remote candidates may be considered.

EEO Statement

Aligos Therapeutics, Inc., is an Equal Opportunity Employer. We do not discriminate against qualified applicants based upon any protected group status, including but not limited to race, religion, color, creed, sex (including breastfeeding and related conditions), gender identity/gender expression, pregnancy (including childbirth and related conditions), national origin, ancestry, age, marital status, military or veteran status, sexual orientation, genetic information, physical or mental disability or medical condition as defined by applicable equal opportunity laws. Any request for accommodation can be directed to Aligos People Operations.

Compensation

The anticipated contract rate for fully qualified candidates applying for this role will be $110–$120/hr. The final contract rate offered will be dependent on several factors that include but are not limited to relevant previous experience including duration and type of experience within the industry and education.