Statistical Analyst

Role Summary

The Statistical Analyst, Biostatistics is responsible for developing statistical analysis designs, writing SAS programs, and providing statistical interpretation in accordance with project and regulatory requirements along with summarizing findings in reports and publications.

Responsibilities

• Provide statistical analysis inputs and programming in a team environment to address project objectives.
• Adhere to company and regulatory guidelines in analysis and reporting of statistical findings.
• Understand and consider complexity of clinical studies while providing analysis of data.
• Develop optimal models for analysis and interpretation of clinical findings.
• Create extensive SAS programs with sufficient detail and ease of interpretation to implement potential complex designs of studies, and have a thorough knowledge to implement programs for linear regression models, linear mixed models, generalized linear models, generalized linear mixed models, non-linear models, survival analysis, simulation studies (e.g., MCMC) and power/sample size estimation.
• Responsible for developing/understanding/adhering to statistical methodologies as set forth in project requirements (e.g., Statistical Analysis Plan [SAP]) and ensuring methodologies are being implemented appropriately.
• Generate tables, figures and listings (TFLs) for presentation and interpretation of results in accordance with project requirements.
• Assist in development of documents or presentations as needed.
• Identify, interpret, and communicate meaningful findings to key individuals (i.e., answer the “so what” questions).

Qualifications

• Bachelor’s degree in Math/Statistics/Biostatistics or related field, from an accredited college or university. Advanced degree preferred.
• At least 3 years of SAS, R and/or Python programming experience required. Independent working knowledge of SAS macros is preferred.
• Minimum 2 years Assistantship/Internship of statistical experience in university, biotech, pharma, government, or research institutes.
• Proven ability to work independently and in a team environment.
• Excellent analytical and problem-solving skills.
• Excellent written and verbal English communication skills.
• Demonstrated knowledge of statistical methods and models.
• The ability to independently write SAS programs in adherence to clinical and statistical objectives.
• Knowledge of clinical terms, clinical study designs and the drug and/or device approval process.

Skills

• Knowledge of the drug/device approval process.
• Experience with statistical modeling, SAS programming, and data interpretation.
• Strong communication and collaboration abilities.

Education

• Bachelor’s degree in Math/Statistics/Biostatistics or related field; advanced degree preferred.