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About the Role
This role provides subject matter expertise for the statistical design, analysis, and interpretation of clinical trial data. The position reports to the Head of Biostatistics and collaborates with cross-functional teams to ensure the integrity, accuracy, and scientific rigor of statistical analyses. The individual will contribute to strategic planning of study design and provide guidance on statistical methodology, data analysis, and reporting to support late-stage clinical development programs.
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.
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.
Skills
- SAS
- R
- Python
Location
- South San Francisco, CA
- Remote
Work Type
- Temporary
- Part-time
- Remote
Experience Level
- 3+ years
- 4-6 years
Education Level
- Master's degree in biostatistics, statistics or a related scientific discipline
- PhD in Biostatistics, Statistics, Mathematics, Epidemiology, or a related scientific discipline
Salary/Compensations
- $110– $120/hr
About the Company
- Founded in 2018 and headquartered in South San Francisco, California, Aligos was founded with the mission to become a leader in the treatment of liver and viral diseases.
- Our team members thrive in a science-first culture with many critical domains represented on staff.
- Our team of respected scientists use their decades of experience to build a cutting-edge pipeline of transformative treatment options that have the potential to change lives.
- Aligos, you’ll have an opportunity to pursue your passion among the best in the industry.
- It’s a place where you’ll be challenged, supported, and inspired.
- A highly-collaborative, fast-paced work environment where we honor accountability, transparency, and diversity.
Equal Opportunity
- 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.