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Key Responsibilities and Required Skills for Biostatistician

💰 $65,000 – $140,000

BiostatisticsData AnalysisClinical ResearchEpidemiologyLife Sciences

🎯 Role Definition

A Biostatistician applies statistical methodologies to design studies, analyze complex datasets, and interpret results in clinical trials, epidemiological research, or health sciences projects. They collaborate closely with scientists, clinicians, and regulatory teams to ensure data-driven insights inform scientific and business decisions. The role requires proficiency in statistical programming, data management, experimental design, and the ability to communicate findings to both technical and non-technical audiences.

📈 Career Progression

Typical Career Path

Entry Point From:

  • Statistical Analyst
  • Research Associate with quantitative experience
  • Data Analyst in health or life sciences

Advancement To:

  • Senior Biostatistician
  • Lead Biostatistician / Principal Biostatistician
  • Director of Biostatistics / Head of Data Science

Lateral Moves:

  • Clinical Data Scientist
  • Epidemiologist
  • Health Economics and Outcomes Research (HEOR) Analyst

Core Responsibilities

Primary Functions

  1. Design statistical analysis plans (SAPs) for clinical trials, observational studies, and epidemiological research.
  2. Develop and validate statistical models for primary and secondary endpoints, biomarker analysis, and predictive modeling.
  3. Analyze large-scale clinical, genomic, or survey datasets using advanced statistical techniques.
  4. Prepare detailed reports, tables, figures, and listings to summarize study results for internal and external stakeholders.
  5. Collaborate with clinical teams to ensure appropriate study design, randomization, sample size calculation, and endpoint selection.
  6. Implement and maintain reproducible, high-quality statistical programming workflows using SAS, R, or Python.
  7. Provide guidance on data management, quality control, and data cleaning procedures to ensure integrity and accuracy of datasets.
  8. Conduct interim analyses and adaptive trial monitoring, advising stakeholders on trends, safety, and efficacy.
  9. Support regulatory submissions by preparing analysis datasets, statistical outputs, and technical documentation according to FDA, EMA, or ICH guidelines.
  10. Collaborate with cross-functional teams including medical writing, clinical operations, and regulatory affairs to align statistical analysis with study objectives.
  11. Mentor junior statisticians, analysts, and interns, providing training in statistical methods, programming, and reporting standards.
  12. Conduct exploratory data analysis to identify patterns, trends, and anomalies in clinical or epidemiological datasets.
  13. Apply survival analysis, longitudinal data analysis, mixed models, and generalized linear models to complex datasets.
  14. Review study protocols and ensure statistical integrity in study design, endpoint definition, and hypothesis testing.
  15. Participate in project planning, milestone tracking, and resource allocation to ensure timely completion of analyses.
  16. Contribute to scientific publications, abstracts, and presentations by providing statistical expertise, generating figures, and validating results.
  17. Develop and implement standard operating procedures (SOPs) for statistical analysis and reporting within the organization.
  18. Evaluate new statistical methods, tools, and software to improve analytical efficiency and accuracy.
  19. Provide ad-hoc statistical support for internal teams, including predictive modeling, risk assessment, and experimental design consultation.
  20. Ensure compliance with ethical standards, regulatory requirements, and data privacy guidelines throughout study design, data analysis, and reporting processes.

Secondary Functions

  • Support exploratory analyses to inform research strategy and study design optimization.
  • Contribute to departmental initiatives, statistical best practices, and continuous improvement of analytic methodologies.
  • Assist in cross-functional workshops to align statistical approaches with organizational objectives.

Required Skills & Competencies

Hard Skills (Technical)

  • Proficiency in statistical software such as SAS, R, or Python.
  • Strong understanding of study design, including clinical trials, observational studies, and epidemiology.
  • Expertise in survival analysis, regression modeling, longitudinal data analysis, and generalized linear models.
  • Data management skills, including data cleaning, merging, transformation, and quality control.
  • Ability to develop reproducible, well-documented analysis pipelines.
  • Knowledge of regulatory guidelines (FDA, EMA, ICH) and compliance standards.
  • Experience with sample size calculation, power analysis, and randomization strategies.
  • Ability to create clear tables, figures, and listings for regulatory submissions or publications.
  • Knowledge of biomarker analysis, pharmacokinetics, or health outcomes research is a plus.
  • Experience with data visualization tools and reporting dashboards.

Soft Skills

  • Excellent written and verbal communication skills.
  • Strong analytical and problem-solving abilities.
  • Attention to detail and high level of accuracy.
  • Ability to work collaboratively in multidisciplinary teams.
  • Time management and project management skills.
  • Mentoring and leadership skills for junior staff development.
  • Adaptability to fast-paced and evolving research environments.
  • Critical thinking to interpret complex statistical results in a biological or clinical context.
  • Integrity and adherence to ethical standards in research and data analysis.
  • Continuous learning mindset to stay current with emerging statistical methods and tools.

Education & Experience

Educational Background

Minimum Education:

  • Bachelor’s degree in Statistics, Biostatistics, Mathematics, Epidemiology, or related quantitative field.

Preferred Education:

  • Master’s degree or PhD in Biostatistics, Statistics, Epidemiology, or a closely related discipline.

Relevant Fields of Study:

  • Biostatistics
  • Statistics
  • Epidemiology
  • Mathematics
  • Public Health
  • Data Science

Experience Requirements

Typical Experience Range:

  • 2–5 years of experience in statistical analysis, clinical research, or epidemiology.

Preferred:

  • 5+ years of experience in biostatistics, clinical trial analysis, or life sciences research with demonstrated expertise in regulatory submissions and mentoring junior staff.
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