Biostatistician (Data Insights Specialist)
3 weeks ago
Unreal Gigs is seeking a highly skilled Biostatistician to join our team of data experts. As a Biostatistician, you will play a crucial role in analyzing and interpreting health data to drive critical decisions in clinical trials, medical research, and healthcare strategy.
Key Responsibilities:- Design and Analyze Clinical Trials:
- Collaborate with clinical researchers to design statistically sound clinical trials, determining sample sizes, randomization strategies, and statistical analysis plans.
- Analyze trial data to assess drug efficacy, safety, and outcomes.
- Conduct complex statistical analyses for a range of medical and epidemiological studies.
- Analyze data from observational studies, longitudinal research, and experimental trials, providing insights into trends, associations, and causal relationships.
- Build and refine statistical models that help understand and predict patient outcomes, disease progression, and treatment efficacy.
- Work with big data, including patient registries, electronic health records, and genetic data, to develop predictive algorithms.
- Support the preparation of regulatory submissions, ensuring that statistical methodologies meet regulatory standards set by agencies like the FDA or EMA.
- Provide statistical analysis results and interpretations for clinical study reports (CSRs) and regulatory filings.
- Develop and implement data validation strategies to ensure the accuracy and reliability of data used in clinical trials and research studies.
- Conduct data cleaning and manage missing data, ensuring that analyses are based on high-quality data.
- Create detailed reports, data visualizations, and presentations that communicate the results of statistical analyses clearly to both technical and non-technical stakeholders.
- Ensure that findings are presented in a way that supports decision-making in clinical research and healthcare.
- Provide guidance to clinical research teams on statistical best practices, including study design, data collection methods, and appropriate statistical tests.
- Ensure that research methodologies align with scientific and ethical standards.
Requirements:
Required Skills:
- Biostatistics and Data Analysis Expertise: Strong expertise in biostatistics, with experience applying statistical techniques to clinical trials, medical research, and epidemiological studies.
- Clinical Trial Design and Analysis: Experience in designing and analyzing clinical trials, including sample size calculations, randomization techniques, and interim analysis.
- Data Modeling and Statistical Methods: Expertise in developing statistical models and applying methods such as survival analysis, mixed-effects models, and Bayesian analysis.
- Regulatory Knowledge: Understanding of regulatory standards, including FDA and EMA guidelines, for statistical methodologies in clinical trials.
- Communication and Collaboration: Excellent collaboration skills with the ability to work with multidisciplinary teams, including clinicians, researchers, and regulatory professionals.
Educational Requirements:
- Master's or Ph.D. in Biostatistics, Statistics, Epidemiology, or a related field.
- Certifications or additional coursework in clinical trial design, statistical programming, or healthcare data analysis are a plus.
Experience Requirements:
- 3+ years of experience in biostatistics, with hands-on experience in analyzing clinical trial data or conducting medical research.
- Experience working with statistical software such as SAS, R, SPSS, or Python for data analysis and model development.
- Experience working in regulated environments and supporting regulatory submissions (e.g., FDA, EMA) is highly desirable.
Benefits:
- Health and Wellness: Comprehensive medical, dental, and vision insurance plans with low co-pays and premiums.
- Paid Time Off: Competitive vacation, sick leave, and 20 paid holidays per year.
- Work-Life Balance: Flexible work schedules and telecommuting options.
- Professional Development: Opportunities for training, certification reimbursement, and career advancement programs.
- Wellness Programs: Access to wellness programs, including gym memberships, health screenings, and mental health resources.
- Life and Disability Insurance: Life insurance and short-term/long-term disability coverage.
- Employee Assistance Program (EAP): Confidential counseling and support services for personal and professional challenges.
- Tuition Reimbursement: Financial assistance for continuing education and professional development.
- Community Engagement: Opportunities to participate in community service and volunteer activities.
- Recognition Programs: Employee recognition programs to celebrate achievements and milestones.
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