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Ranger Evans
Clinical Statistical Programmer
Summary
Seasoned Clinical Statistical Programmer with 5+ years of experience in the pharmaceutical industry. Expertise in designing and implementing statistical analysis plans, utilizing advanced statistical techniques, and ensuring compliance with regulatory guidelines. Proficient in SAS, R, and Python, with a deep understanding of CDISC standards. Collaborated with clinical research teams to generate comprehensive study reports and provide statistical support throughout the clinical trial lifecycle.
Key skills include:
- SAS Programming
- R Programming
- SQL
- CDISC Standards (SDTM, ADaM)
- Clinical Trial Design
- Statistical Modeling
Education
Master’s Degree in Statistics or Biostatistics
April 2017
Skills
- SAS Programming
- R Programming
- SQL
- CDISC Standards (SDTM, ADaM)
- Clinical Trial Design
- Statistical Modeling
Work Experience
Clinical Statistical Programmer
- Conducted data cleaning, validation, and transformation to ensure data integrity and accuracy.
- Applied advanced statistical techniques, such as Bayesian modeling, mixed models, and survival analysis, to address complex clinical research questions.
- Collaborated with medical writers to develop clinical trial protocols and statistical sections of regulatory submissions.
- Provided statistical consultation and support to clinical research investigators and project managers.
Clinical Statistical Programmer
- Collaborated with clinical research teams to design and implement statistical analysis plans for phase II and III clinical trials.
- Utilized SAS, R, and Python to develop and validate statistical models for safety and efficacy endpoints.
- Generated comprehensive clinical study reports, including statistical tables, figures, and interpretation of results.
- Ensured compliance with regulatory guidelines (ICHGCP, FDA, EMA) for statistical analysis and reporting.
Accomplishments
- Collaborated with clinical researchers to design and implement statistical analyses for multiple clinical trials, ensuring adherence to regulatory guidelines.
- Developed and validated statistical methodologies to handle missing data in clinical trials, resulting in more accurate and reliable study results.
- Utilized advanced statistical techniques, such as Bayesian modeling and machine learning, to optimize patient selection and improve trial outcomes.
- Developed userfriendly software tools to automate statistical analyses and streamline clinical trial data management.
- Collaborated with regulatory bodies to provide statistical support for clinical trial submissions and ensure data integrity.
Awards
- Received recognition for outstanding contributions to a clinical trial involving over 10,000 participants, leading to a successful regulatory approval.
- Recognized by the International Society for Clinical Biostatistics for developing innovative statistical methods that improved the efficiency of clinical trials.
- Awarded a research grant from the National Institutes of Health to develop statistical models for personalized medicine.
Certificates
- Certified Statistical Programmer (CSP)
- Certified Clinical Research Professional (CCRP)
- SAS Certified Statistical Business Analyst
- RStudio Certified Professional
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How To Write Resume For Clinical Statistical Programmer
Quantify your accomplishments:
Use numbers and metrics to demonstrate the impact of your work, such as the number of trials you have supported or the percentage of projects that met regulatory deadlines.Highlight your expertise in statistical techniques:
Showcase your proficiency in advanced statistical methods, such as Bayesian modeling or machine learning, and how you have applied them to solve complex clinical research problems.Emphasize your understanding of regulatory guidelines:
Demonstrate your knowledge of ICHGCP, FDA, and EMA guidelines and how you have ensured compliance in your work.Use industry-specific keywords:
Include relevant keywords throughout your resume, such as ‘clinical trial design,’ ‘statistical modeling,’ and ‘CDISC standards,’ to make it easier for recruiters to find your application.
Essential Experience Highlights for a Strong Clinical Statistical Programmer Resume
- Collaborate with clinical research teams to design and implement statistical analysis plans for clinical trials
- Utilize SAS, R, and Python to develop and validate statistical models for safety and efficacy endpoints
- Generate comprehensive clinical study reports, including statistical tables, figures, and interpretation of results
- Ensure compliance with regulatory guidelines (ICHGCP, FDA, EMA) for statistical analysis and reporting
- Conduct data cleaning, validation, and transformation to ensure data integrity and accuracy
- Apply advanced statistical techniques, such as Bayesian modeling, mixed models, and survival analysis, to address complex clinical research questions
- Collaborate with medical writers to develop clinical trial protocols and statistical sections of regulatory submissions
Frequently Asked Questions (FAQ’s) For Clinical Statistical Programmer
What is the role of a Clinical Statistical Programmer?
A Clinical Statistical Programmer collaborates with clinical research teams to design, implement, and analyze statistical plans for clinical trials. They ensure compliance with regulatory guidelines, develop statistical models, and generate comprehensive study reports.
What are the key skills required for a Clinical Statistical Programmer?
Key skills include proficiency in SAS, R, and Python, knowledge of CDISC standards, experience in clinical trial design, statistical modeling, and regulatory compliance.
What are the career prospects for a Clinical Statistical Programmer?
Clinical Statistical Programmers with experience and expertise can advance to roles such as Senior Statistical Programmer, Statistical Team Lead, or Director of Biostatistics.
What is the average salary for a Clinical Statistical Programmer?
The average salary for a Clinical Statistical Programmer varies depending on experience, location, and company size, but typically ranges from $80,000 to $120,000 per year.
What are the top companies that hire Clinical Statistical Programmers?
Top companies that hire Clinical Statistical Programmers include pharmaceutical companies such as Bristol-Myers Squibb, Roche, and Pfizer, as well as contract research organizations (CROs) such as IQVIA and Parexel.
What is the difference between a Clinical Statistical Programmer and a Biostatistician?
While both roles involve statistical analysis in clinical research, Clinical Statistical Programmers focus on the implementation and analysis of statistical plans, while Biostatisticians are more involved in the design and interpretation of clinical studies.
What is the job outlook for Clinical Statistical Programmers?
The job outlook for Clinical Statistical Programmers is expected to be strong due to the increasing demand for clinical trials and the need for qualified professionals to analyze and interpret clinical data.