Clinical Sas Programmer Resume Samples

Description :

1. Conducted relevant Clinical data analysis on data captured during Phase I /II/III of Randomized, Double-Blinded clinical trials, conducted at multiple centers evaluating various doses of an investigational agent against placebo for Thermal Injury.
2. Created Programming specifications documents for creating analysis datasets for both safety and efficacy.
3. Developed Analysis datasets for Safety and Efficacy data.
4. Gained strong mapping knowledge in submission of data in CDISC SDTM format, based on CDISCSDTM Implementation guide.
5. Reviewed Protocols, Case Report Forms, and Statistical Analysis Plans for Clinical trials.
6. Involved in validation of derived datasets and other coded programs using PROC COMPARE.
7. Involved in creation and validation of datasets according of CDISC SDTM standards following specifications document.

Experience

10+ Years

Level

Senior

Education

Biochemistry

Description :

1. Created metadata for the analysis datasets.
2. Produced analysis ready datasets using standard set of macro tools and non-standard tools according to the CDISC standards.
3. Developed SDTM data mapping and created SDTM datasets per CDISC standards.
4. Designed and develop Statistical analysis data set ADaM in CDISC standards.
5. Provided SAS Programming and analysis support for phase II clinical trials Created a SAS customized reports using Proc Report, Proc Summary, Proc Means, Proc Freq, Proc Sort and Proc Transpose.
6. Used sorting and merging techniques on the input data sets for Data Preparation, to get the required output and then writing the code using SAS tools.
7. Provided programming support for nda submission. Generated sas macros/programs for tables/ard (analysis ready dataset)/arp(analysis ready program)/define file.

Experience

7-10 Years

Level

Senior

Education

Bachelors

Description :

1. Produced analysis datasets, listings, tables and graphs for NDA submission.
2. Provided SAS programming and analysis support for Phase II clinical trials.
3. Performed data analysis, statistical analysis, created listings, graphs and reports using SAS and various SAS procedures.
4. Produced quality customized reports by using Proc Report, Summary and also provided descriptive statistics using Proc Means, Frequency, and Univariate.
5. Produced analysis ready datasets using standard set of macro tools and non-standard tools according to the CDISC standards.
6. Developed SDTM data mapping and created SDTM datasets per CDISC standards.
7. Designed and develop Statistical analysis data set ADaM in CDISC standards.

Experience

2-5 Years

Level

Junior

Education

Bachelors

Description :

1. Produced quality customized reports by using Proc Report, Summary and also provided descriptive statistics using Proc Means, Frequency, and Univariate.
2. Used sorting and merging techniques on the input data sets for Data Preparation, to get the required output and then writing the code using SAS tools.
3. Created complex and reusable Macros, used existing Macros, developed SAS Programs for Data cleaning, Data validation, Data analysis and Report generation.
4. Created analysis data sets and performed statistical analysis on raw data to achieve safety and efficacy objectives of the study using SAS procedures like Proc Means, Proc Freq, Proc Reg, Proc Sort etc.
5. Analyzed using SAS Statistical Procedures such as Proc Means, Proc Tabulate, and Proc Freq.
6. Performed validation of data sets, tables and listings created for safety and efficacy studies which includes- Adverse events, Concomitant medications, Laboratory data values and Vital signs.
7. Coordinated project start-up activities, creation of global programs, tracking spreadsheets, and other required documentation.
   

Experience

5-7 Years

Level

Executive

Education

MS In Chemistry

Description :

1. Worked on conversion .XPT files with the data into SAS Data Sets with the SAS Program, PROC COPY IN = tran out-raw by select file name.
2. Developed specifications and data mapping for study Level 2 Database.
3. Completed Clinical Data Management activities on assigned projects accurately and efficiently Reviewed, resolved, and documented clinical data .
4. Imported and converted PKDATA and PKARDATA .xls files into SAS DATA Sets through SAS Application environment.
5. Developed NONMEM datasets POPPK and ER.
6. Analyzed the Data and generated the Statistical reports with Graphs for POPPK analysis and ER parameters (auc, cmax, tmax, vl, clearance, acc.ratio) for the Pharmacologists to analyze the drug performance.
7. Developmented and maintened of SAS data and statistical analysis programs to support drug development projects.

Experience

5-7 Years

Level

Executive

Education

Health Informatics

Description :

1. Responsible for collection, evaluation, initial assessment, and timely submission of adverse experience reports related to the companies marketed and investigational drug products.
2. Developed analysis datasets based on the guidelines provided in the SAP (Statistical Analysis Plan).
3. Generated reports on AE (Adverse Events) and SAE (Serious Adverse Events) Demographics, Laboratory shift tables by referring to the Statistical Analysis Plan and the Mockup Shells.
4. Validated TLGs by writing competing code and comparing the values produced with the source report values.
5. Extracted data from the database by SQL PASS THROUGH FACILITY and LIBNAME facility.
6. Created reports in PDF, Excel and HTML formats using ODS statements.
7. Developed macro programs defining the macro parameters using different debugging options like MPRINT, MLOGIC, and SYMBOLGEN.

Experience

7-10 Years

Level

Management

Education

Biotechnology

Description :

1. Developed Macros to create tables, graphs and listings for routine reports.
2. Provided custom data listings, tables and figures for inclusion in Clinical Study Report (CSR) documentation.
3. Performed statistical analyses using PROC GLM and PROC MIXED following the instructions in Statistical Analysis Plan.
4. Combined and Modified SAS datasets for statistical analysis using SAS data step and procedures including PROC SQL Create SAS Macros to develop SAS Programs for clinical data Cleaning, Validation, Analysis and Report generation.
5. Supported Staff programming needs and performed Ad hoc requests.
6. Provided ad-hoc programming for special requested tables. Performed statistical modeling according to sap.
7. Wrote sas macros/programs for analysis datasets; generated tables and listings in safety analysis in a dozen of projects.

Experience

7-10 Years

Level

Management

Education

Informatics

Description :

1. Wanted to streamline the production of clinical trials.
2. Implemented statistical reporting processes for regular data collection and clinical data analysis.
3. Analyzed Phase I to Phase IV Clinical Trials data.
4. Developed and maintained programs in SAS using SAS tools for Windows in a user support environment.
5. Extensived experience with the SAS programming and in data step and with various SAS Procedures in Base SAS and SAS/Stat, including thorough knowledge of SAS Macro Language.
6. Performed Data analysis, statistical analysis, generated reports, listings and graphs using SAS Tools such as SAS/Base, SAS/Macros and SAS/Graph, SAS/SQL.
7. Created and edited title/footnote files in excel for tables and listings (toc files).

Experience

7-10 Years

Level

Management

Education

Bachelors In Pharmacy

Description :

1. Specialized in treatments that help people with disorders of central nervous system and respiratory ailments.
2. Developed SAS programs for creating intermediate data sets, generating statistical reports and graphs as per statistical analysis plan.
3. Generated tables and listings based on CDISC (SDTM V3.1.2) standard.
4. Created Integrated Summaries of Efficacy (ISE) and Safety (ISS) as per FDA compliance.
5. Involved in data validation and creation of several macro programs which were modified and used for validation across different studies and protocols.
6. Customized data output using the sas ods report writing interface, such as manipulating rtf file structure.
7. Ensured database structure consistency, data accuracy, and quality check (qc) for statistical output.

Experience

2-5 Years

Level

Executive

Education

Biology

Description :

1. Performed data validation using parallel programming and sas proc compare.
2. Created clinical study tables and listings by effectively used data steps, various procedures, and additional sas tools such as macros, ods, sql, and advanced programming methodologies such as sas/stat and sas/graph.
3. Created the cdisc compliance of data set under sdtm and adam standards.
4. Developed sas programs for creating intermediate data sets, generating statistical reports and graphs as per statistical analysis plan.
5. Generated sas customized reports according to fda standards using the data null technique for evaluations.
6. Worked on multiple projects at the same time involving different kinds of data including demographic, adverse events, vital signs and laboratory data.
7. Performed validation and quality control checks on datasets received from data management.

Experience

2-5 Years

Level

Executive

Education

Masters Of Science