Biostatistics Research Scientist

2 months ago

Carnegie PA United States Joulé Full time

Title: Biostatistics Research Scientist

Please read the following job description thoroughly to ensure you are the right fit for this role before applying.
Location: Onsite, Oakland, PA
Schedule: M-F 8:30 am-5 pm
Type: Direct/Permanent

Overview:

The Biostatistician in Clinical Research will play a critical role in the design, analysis, and interpretation of clinical trial data to ensure the validity and accuracy of research outcomes. This position requires working closely with multidisciplinary teams, including clinicians, researchers, and data management teams, to support ongoing clinical trials and other related research studies. The Biostatistician will apply advanced statistical methodologies to analyze clinical data and will be responsible for contributing to study protocols, statistical analysis plans, and final study reports. If you are intrigued and would like to learn more, we encourage you to submit your application
Responsibilities

Collaborating with clinical investigators to design studies, analyze data, and interpret results.
Applying advanced statistical methods to clinical trials, including survival analysis, longitudinal data analysis, and Bayesian approaches.
Contributing to grant proposals, research manuscripts, and presentations.
Perform statistical analysis on clinical trial data to ensure the accuracy and relevance of research findings. This includes developing and executing statistical models, methods, and techniques appropriate to the study design.
Collaborate with clinical researchers to design studies, including determining sample size, randomization, and stratification methods. Provide input on study protocols to ensure proper data collection and analysis.
Ensure data integrity by monitoring data quality and completeness during the trial. Work closely with data management teams to identify and resolve data discrepancies.
Create statistical analysis plans (SAPs) and contribute to interim and final reports, including the preparation of tables, figures, and listings (TFLs) for clinical trial publications and regulatory submissions.
Collaborate with cross-functional teams, including clinical investigators, data scientists, and project managers, to interpret data and develop research conclusions. Present findings in a clear and accessible manner to stakeholders.
Ensure all statistical work complies with relevant regulatory guidelines (e.g., FDA, EMA) and Good Clinical Practices (GCP).
Use statistical software such as SAS, R, or STATA for data analysis. Stay current with new developments in biostatistics and clinical trial methodology.

Requirements Master's or Ph.D. in Biostatistics, Statistics, or a related field.
Ideally Ph.D. in Biostatistics or a related field and previous experience in health-related research
Minimum of 1-5 years of experience as a biostatistician in clinical research, preferably in a pharmaceutical, biotech, or academic research setting.
Proficiency in statistical programming languages such as SAS, R, or STATA.
Strong knowledge of clinical trial design, statistical methods, and regulatory requirements (FDA, EMA).
Experience with developing statistical analysis plans (SAPs) and interpreting clinical trial data.
Excellent communication skills with the ability to present complex data and statistical concepts to non-statisticians.
Strong problem-solving skills and the ability to work independently as well as collaboratively in a team-oriented environment.

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