Job Description

Do you have a passion for using data to drive advancements in healthcare, medicine, and public health? Are you excited about applying statistical methods to clinical trials, epidemiological studies, and drug development to discover new insights that can improve patient outcomes? If you’re ready to make a significant impact by analyzing complex data and providing actionable insights, our client has the perfect opportunity for you. We’re seeking a Biostatistician (aka The Data-Driven Health Innovator) to analyze and interpret health data, driving critical decisions in clinical trials, medical research, and healthcare strategy.

As a Biostatistician at our client , you will collaborate with clinical researchers, data scientists, and regulatory teams to provide statistical expertise throughout the entire lifecycle of medical research. From study design to data analysis and interpretation, your work will play a pivotal role in ensuring that clinical trials are scientifically sound, data-driven, and aligned with regulatory requirements.

Key Responsibilities:

1. Design and Analyze Clinical Trials:
• Collaborate with clinical researchers to design statistically sound clinical trials, determining sample sizes, randomization strategies, and statistical analysis plans. You’ll analyze trial data to assess drug efficacy, safety, and outcomes.
2. Perform Statistical Analysis for Research Studies:
• Conduct complex statistical analyses for a range of medical and epidemiological studies. You’ll analyze data from observational studies, longitudinal research, and experimental trials, providing insights into trends, associations, and causal relationships.
3. Develop Statistical Models and Algorithms:
• Build and refine statistical models that help understand and predict patient outcomes, disease progression, and treatment efficacy. You’ll work with big data, including patient registries, electronic health records, and genetic data, to develop predictive algorithms.
4. Collaborate on Regulatory Submissions:
• Support the preparation of regulatory submissions, ensuring that statistical methodologies meet regulatory standards set by agencies like the FDA or EMA. You’ll provide statistical analysis results and interpretations for clinical study reports (CSRs) and regulatory filings.
5. Ensure Data Quality and Integrity:
• Develop and implement data validation strategies to ensure the accuracy and reliability of data used in clinical trials and research studies. You’ll conduct data cleaning and manage missing data, ensuring that analyses are based on high-quality data.
6. Generate Reports and Visualizations:
• Create detailed reports, data visualizations, and presentations that communicate the results of statistical analyses clearly to both technical and non-technical stakeholders. You’ll ensure that findings are presented in a way that supports decision-making in clinical research and healthcare.
7. Advise on Study Protocols and Statistical Best Practices:
• Provide guidance to clinical research teams on statistical best practices, including study design, data collection methods, and appropriate statistical tests. You’ll 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. You’re proficient in statistical software such as SAS, R, SPSS, or Python.
• Clinical Trial Design and Analysis: Experience in designing and analyzing clinical trials, including sample size calculations, randomization techniques, and interim analysis. You know how to structure trials to ensure robust statistical outcomes.
• Data Modeling and Statistical Methods: Expertise in developing statistical models and applying methods such as survival analysis, mixed-effects models, and Bayesian analysis. You’re familiar with handling longitudinal and multivariate data.
• Regulatory Knowledge: Understanding of regulatory standards, including FDA and EMA guidelines, for statistical methodologies in clinical trials. You can prepare statistical analysis plans and provide inputs for regulatory submissions.
• Communication and Collaboration: Excellent collaboration skills with the ability to work with multidisciplinary teams, including clinicians, researchers, and regulatory professionals. You can clearly communicate complex statistical concepts to non-experts.

Educational Requirements:

• Master’s or Ph.D. in Biostatistics, Statistics, Epidemiology, or a related field. Equivalent experience in biostatistics applied to healthcare or clinical research is highly valued.
• 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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