Clinical Sas Programmer Resume Samples

Description :

1. Executed detailed clinical data analysis for Phase I to III trials, focusing on efficacy and safety of investigational agents through robust statistical methods.
2. Developed programming specifications and produced analysis datasets for both safety and efficacy evaluations.
3. Created and validated datasets in accordance with CDISC SDTM standards, ensuring accurate data representation for regulatory submissions.
4. Reviewed and interpreted study protocols, Case Report Forms, and Statistical Analysis Plans to align programming efforts with clinical objectives.
5. Conducted validation of derived datasets and SAS programs utilizing PROC COMPARE to ensure integrity and accuracy of clinical data.
6. Collaborated with cross-disciplinary teams to provide SAS programming expertise in the analysis and reporting of clinical trial data.
7. Designed and implemented automated reporting solutions, enhancing the efficiency of data presentation and analysis processes.

Experience

10+ Years

Level

Senior

Education

MS Biostatistics

Description :

1. Developed and validated SAS programs to create analysis datasets and statistical reports for Phase II clinical trials.
2. Automated data processing tasks using SAS macros, enhancing efficiency and reducing manual errors.
3. Generated comprehensive reports utilizing PROC REPORT, PROC SUMMARY, and PROC MEANS to summarize clinical findings.
4. Ensured compliance with FDA and ICH guidelines during the programming and reporting phases.
5. Participated in cross-functional meetings to discuss data insights and reporting strategies with stakeholders.
6. Mentored junior programmers in SAS programming techniques and best practices.
7. Developed and validated SAS programs for clinical trial data analysis, ensuring compliance with regulatory standards.

Experience

7-10 Years

Level

Senior

Education

M.S. Biostatistics

Description :

1. Produced analysis datasets, listings, tables, and graphs for regulatory submission, ensuring adherence to industry standards.
2. Created analysis-ready datasets using a combination of standard macro tools and custom solutions to meet CDISC guidelines.
3. Designed and developed Statistical Analysis Datasets (ADaM) in compliance with CDISC standards for multiple clinical trials.
4. Collaborated with biostatisticians to validate statistical methodologies and ensure robust data analysis.
5. Conducted comprehensive data validation processes, including checks for accuracy and completeness of clinical trial data.
6. Utilized SAS programming to generate insightful reports that support clinical decision-making and regulatory submissions.
7. Engaged in continuous improvement initiatives to streamline data processing workflows and enhance operational efficiency.

Experience

2-5 Years

Level

Junior

Education

M.S. Biostatistics

Description :

1. Produced high-quality statistical reports utilizing SAS procedures such as Proc Report and Proc Means, enhancing data interpretation for clinical studies.
2. Implemented efficient data sorting and merging techniques for data preparation, ensuring accuracy and reliability of analysis outputs.
3. Created comprehensive analysis datasets and performed robust statistical analyses to evaluate safety and efficacy outcomes of clinical trials.
4. Validated datasets, tables, and listings for accuracy in safety and efficacy studies, ensuring compliance with study protocols.
5. Coordinated project initiation activities, including the development of global programming specifications and tracking documentation.
6. Collaborated with cross-functional teams to ensure seamless data management processes throughout the clinical trial lifecycle.
7. Utilized advanced SAS techniques to produce Tables, Listings, and Graphs (TLGs) in accordance with regulatory requirements.

Experience

5-7 Years

Level

Executive

Education

M.S. Biostatistics

Description :

1. Converted .XPT files into SAS datasets using PROC COPY, ensuring data integrity and adherence to study protocols.
2. Designed and documented specifications for study-level databases, facilitating accurate data collection and analysis.
3. Conducted thorough Clinical Data Management activities, ensuring timely resolution of data discrepancies.
4. Imported and transformed PKDATA and PKARDATA .xls files into SAS datasets, streamlining data integration processes.
5. Developed datasets for NONMEM analysis, contributing to pharmacokinetic modeling efforts.
6. Generated comprehensive statistical reports and graphs for pharmacologists, aiding in the evaluation of drug performance metrics.
7. Maintained and enhanced SAS programs for data management, supporting ongoing drug development projects.

Experience

5-7 Years

Level

Executive

Education

M.S. Biostatistics

Description :

1. Collaborated with biostatisticians and clinical teams to develop and validate statistical analysis datasets in accordance with study protocols.
2. Designed and generated detailed reports, tables, listings, and graphs (TLGs) to present clinical trial data effectively.
3. Utilized SQL and SAS to extract, manipulate, and analyze data from various sources, ensuring accuracy and integrity.
4. Implemented automated reporting solutions, significantly reducing manual effort and increasing efficiency.
5. Conducted quality control checks on datasets and outputs, ensuring compliance with regulatory standards and internal guidelines.
6. Participated in the preparation of regulatory submissions, providing statistical programming support and documentation.
7. Mentored junior programmers in SAS techniques and best practices, fostering a culture of continuous improvement.

Experience

7-10 Years

Level

Management

Education

MS Biostatistics

Description :

1. Engineered and optimized macros to efficiently generate tables, graphs, and listings for routine clinical reports.
2. Delivered tailored data listings, tables, and figures for Clinical Study Report (CSR) documentation, enhancing clarity and compliance.
3. Executed statistical analyses utilizing PROC GLM and PROC MIXED, aligned with the Statistical Analysis Plan (SAP).
4. Consolidated and transformed SAS datasets for statistical analysis, employing advanced SAS data step techniques and PROC SQL.
5. Provided support for ad-hoc programming requests, ensuring timely responses to staff programming needs.
6. Developed specialized statistical models based on SAP guidelines, contributing to project-specific insights.
7. Authored SAS macros to streamline the generation of analysis datasets, tables, and listings for safety assessments across multiple projects.

Experience

7-10 Years

Level

Management

Education

MS Biostatistics

Description :

1. Streamlined clinical trial data production processes, enhancing overall efficiency.
2. Implemented robust statistical reporting methodologies for consistent data collection and analysis.
3. Developed and maintained SAS programs within a user support environment, ensuring optimal performance.
4. Utilized advanced SAS procedures and functions to create comprehensive datasets and reporting tools.
5. Conducted in-depth statistical analyses, generating accurate reports, listings, and graphs using SAS tools.
6. Created and edited documentation for tables and listings, ensuring clarity and compliance with project standards.
7. Collaborated with clinical teams to optimize data workflows and improve data accessibility.

Experience

7-10 Years

Level

Management

Education

M.S. Statistics

Description :

1. Specialized in analyzing clinical data for neurological and respiratory therapeutic areas.
2. Generated statistical tables and listings following CDISC SDTM standards, ensuring compliance with regulatory requirements.
3. Created Integrated Summaries of Efficacy (ISE) and Safety (ISS) in alignment with FDA regulations.
4. Developed and validated macro programs for data validation across various clinical studies.
5. Customized data outputs using SAS ODS, optimizing reporting formats for stakeholder review.
6. Ensured database consistency and data quality checks (QC) for all statistical outputs.
7. Collaborated with cross-functional teams to identify and resolve data discrepancies, enhancing data accuracy.

Experience

2-5 Years

Level

Executive

Education

MS Biostatistics

Description :

1. Executed data validation processes using SAS PROC COMPARE and parallel programming techniques to ensure data accuracy.
2. Developed clinical study tables and listings employing data steps and advanced SAS tools, including macros and ODS.
3. Ensured CDISC compliance of datasets in alignment with SDTM and ADaM standards for regulatory submissions.
4. Created SAS programs for intermediate data sets and statistical reports as outlined in the Statistical Analysis Plan (SAP).
5. Generated customized SAS reports adhering to FDA standards using the data null technique for comprehensive evaluations.
6. Managed multiple projects simultaneously, analyzing diverse data types including demographics, adverse events, and laboratory results.
7. Conducted quality control checks on datasets from data management to maintain high standards of data integrity.

Experience

2-5 Years

Level

Executive

Education

M.Pharm.Chem.