Ephicacy - Senior Statistical Programmer (7-12 yrs)

Job Description :

Key Responsibilities :

- Develop, test, and validate SAS programs to create SDTM, ADAM, and analysis datasets as per the Statistical Analysis Plan (SAP).

- Generate statistical tables, listings, and figures (TLFs) that are accurate, consistent, and compliant with regulatory standards.

- Write and maintain well-documented SAS programs and macros to automate routine tasks and improve efficiency.

- Collaborate with statisticians and data managers to understand study design, data structure, and analysis requirements.

- Develop and execute validation programs to verify the accuracy and completeness of data and statistical outputs.

- Perform peer reviews of SAS programs to identify and resolve potential issues.

- Adhere to quality control standards and best practices to ensure data integrity.

- Understand and apply CDISC SDTM and ADAM standards to map and transform raw data into standardized formats.

- Develop and maintain data mapping specifications and SAS programs to facilitate data integration and analysis.

- Identify and troubleshoot complex data and programming issues.

- Proactively seek opportunities to improve efficiency and quality through automation and innovative solutions.

- Stay updated on the latest advancements in statistical programming and data analysis techniques.

Required Skills and Qualifications :

- Advanced proficiency in SAS programming, including BASE SAS, SAS/STAT, and SAS/GRAPH.

- Strong understanding of statistical concepts and methods.

- 7-12 years of experience in clinical trial data analysis and reporting.

- Knowledge of CDISC SDTM and ADAM standards.

- Excellent problem-solving and analytical skills.

- Strong attention to detail and accuracy.

- Ability to work independently and as part of a team.

- Effective communication and interpersonal skills.

- Advanced degree in statistics, biostatistics, computer science, or a related field.

Desired Skills :

- Experience with statistical software packages like R or Python.

- Knowledge of data management and clinical trial operations.

- Experience with statistical analysis software like SAS/STAT or R.

- Familiarity with regulatory requirements (e., FDA, EMA, ICH-GCP)