Data Clinical

ASHOK KAMBLE

Email: *************@*****.***

Phone: 512-***-****

PROFESSIONAL SUMMARY

Sr. Statistical Programmer/Analyst with 7+ Years of experience in developing and generating TLG by referring to CRF, experience in analysis, design, development, testing and implementation of Clinical Trial Projects in Pharmaceutical industries. Extensive experience in handling multiple projects in given timelines and budgets.

Worked with Senior Statisticians, Medical Writers and Project Managers to provide SAS programming in analyzing the data, generated reports, tables, listings and graphs.

Proficient in SAS procedures like PROC UNIVARIATE, PROC SQL, PROC SORT, PROC MIXED, PROCGPLOT, PROC GCHART, PROC DATASETS, PROC CONTENTS, PROC GLM, PROC LOGISTICS, PROC ANCOVA, PROC FORMAT, etc.

Extensive experience in BASE SAS, SAS MACROS, SAS/STAT, SAS/ACCESS, SAS/GRAPH, SAS-SQL, SAS ODS, SAS/GRAPH in Windows and UNIX environments.

Involved in Programming for Integrated Summaries of Efficacy & Safety (ISE/ISS), IND and NDA for FDA submissions.

Gained experience in analyzing clinical trials data in therapeutic areas including cardiovascular, gastrointestinal, allergy, and other diseases.

Experience in implementing CDISC SDTM for intervention, event and findings domain models and ADaM standards, knowledge of SDTM terminologies

Experienced in producing Excel, RTF formatted files using SAS ODS to produce ad-hoc reports for presentation and further analysis.

Generated data definition tables, transportable files, ISS and ISE for NDA submission.

Expertise in coding, developing processes and documenting Import and Export of data across various platforms.

Designed and developed datasets as per the CDISC standards

Technical Skills

SAS Skills: SAS 9.1.3, SAS 9.1.2, SAS 9.0, SAS 8.2 (SAS/BASE, SAS/GRAPH, SAS/MACRO, SAS/ODS, SAS/STAT, SAS/SQL, SAS/ACESS)

SAS Procedures: PROC Report, Print, Freq, Means, Summary, Univariate, Sql, Sort, Transpose Contents, Options, Import, Export, Format, Anova

Office Applications: MS Access, Excel, Word, PowerPoint

Database: ORACLE, DB2, SQL server

Operating Systems: Windows 95/ 98/2000/XP/NT, UNIX

Education

Bachelors of Biotechnology Engineering, Shivaji University, India

PROFESSIONAL EXPERIENCE

Roche Molecular Systems, Pleasanton, CA Feb’14- April’15

SAS Clinical Programmer (Contract)

Responsibilities:

Created datasets in CDISC SDTM V 3.1.2 format, based on CDISC SDTM implementation guide.

Developing the SAS programs for listings & tables for data review & presentation including ad-hoc reports, CRTs as per CDISC, patients listing mapping of safety database and safety tables.

Using the Base SAS (MEANS, FREQ, SUMMARY, TABULATE, REPORT etc) and SAS/STAT procedures (REG, GLM, ANOVA, and UNIVARIATE etc.) for summarization, Tabulations and statistical analysis purposes.

Worked in Blood Screening and Virology lifecycle studies.

Experienced in statistical procedures like PROC MEANS, PROC FREQ, PROC REPORT, PROC TABULATE, PROC TRANSPOSE, PROC UNIVARIATE, PROC ANOVA and PROC GLM.

Developed Macros for Data import, Tables and Listings.

Involved in creating Analysis datasets and Tables for Integrated Summary of Efficacy (ISE) and Safety (ISS).

Involved in validating the TLF’s generated by the CRO’s and interacted with them for any data issues.

Worked on all domains of SDTM like EX, CM, AE, MH, PD, LB,VS,EG, PK,TA, TV, SUPPQUAL and also on ADSL and BDS datasets of ADAM.

Involved in planning, writing and executing statistical programs designed to analyze data.

Create analysis data sets, graphs, tables and listings for High Priority requests.

Preparing reports and listings in accordance with client specifications, analysis plans and industry guidelines.

Used SAS/ODS to augment the output data and deliver it in different formats including HTML, PDF, RTF and CSV.

Generating the demographic tables, adverse events and serious adverse events reports.

Involved in multiple projects and interacted with other SAS programmers, statisticians and data managers to analyze data.

Exported data to various clients in the form of SAS Transport files over secure servers or on electronic media on regular basis.

Involved in working on define.xml.

Acted as a liaison between biostatistician and programmers working on study for addressing complex data and programming issues.

Involved in handling complex programming and data issues with good clinical practices, and 21 CFR part-11 in clinical and statistical programming assignments

Developed statistical reports based on specifications in analysis plan.

Created tables, listings, and graphs from specifications developed in conjunction with study statisticians.

Created Clinical SAS programs using SAS/ STAT, SAS/GRAPH and SAS/MACRO PROC ANOVA, GLM, MIXED.

Analyzed, developed, implemented and maintained Clinical SAS programs.

Pharmaceutical Product Development, NC Feb '11 – Dec '13

Sr. SAS Programmer (Contract)

Responsibilities:

Involved in Phase I, II, and III of clinical trials and worked through standard CDISC format.

Generate and validate PC/PP, ADPC/ADPP and PK TLFs with Pharmaco-kinetic team including generation of statistical analysis TLFs which uses PROC MIXED, PROC TTEST analysis and also generation of forest plots

Program Safety and Efficacy Analysis Reports for Regulatory Submissions.

Develop programs to generate listings and summary tables for Clinical Study Reports as described in the Statistical Analysis Plan.

Table Programming for Integrated Summary of Efficacy (ISE) and Safety (ISS).

Involved with the Data Integrity and also with Data Cleaning, Data Validation and produced Tables Listings Graphs (TLG).

Prepared new Datasets from raw data files using Import Techniques and modified existing datasets using Set, Merge, Sort, update, Formats, Functions and conditional statements.

Attended and contributed to SDTM Mapping peer workshops where mapping intricacies are discussed and new mappings are agreed upon.

Created CDISC SDTM mapping and Data Definition Document

Responsible to provide complete CDSIC support to study teams, helping them in all aspects of SDTM Mapping.

Developed specifications for database in CDISC format and involved in programming datasets in CDISC format (STDM model 3.1) and managed CDISC database for several studies.

Developed Tables, Listings and Figures using PROC REPORT.

Mapping and integrating external study data to a CDISC-compliant proprietary analysis data system (SDTM).

Provided SDTM Mapping across a wide variety of therapeutic areas such as Oncology, Inflammation and General Medicine.

Biogen Idec, Boston, MA Oct ’09 – Feb ‘11

Sr. SAS Programmer (Contract)

Responsibilities

Created datasets in CDISC SDTM V 3.1.2/3.1.3 IG standards and also have experience in using Open CDISC Validator to check Compliance of SDTM domains.

Responsible for developing the SAS programs following the information stated in Statistical Analysis Plan (SAP).

Involved in the support of Phase II- III clinical trials. Wrote statistical programs for analyses datasets, tables and listings for clinical study reports.

Worked on writing specifications for Analysis datasets following ADaM standards 2.1 and also worked on development and validation of the same.

Involved in using various SAS STAT procedures like PROC ANOVA, GLM, MIXED, LIFETEST, PHREG, LOGISTIC, MI, GLIMMIX, GENMOD etc.

Created ad hoc programs to provide information to the project team and/or client, as required.

Performed validation of SAS-generated output (tables, listings and graphs) via independent programming. Also performed QC check.

Used SAS/Graph for the creation of clinical trial bar charts, line graphs for lab and vital data.

Imported data in the form of SAS datasets from flat files of various formats like pipe delimited, tab delimited, .CSV, .XPT etc.

Developed Macros to generate ad hoc reports weekly, monthly or on a specified cut date.

Created Ad hoc reports using the SAS procedures and used ODS statements to generate rtf and pdf outputs.

Created various study specific macros by implementing debugging options.

Created data quality listings to ensure data correctness.

Satyam Computers, Hyderabad, India Apr ’08 – Sep ’09

SAS Programmer

Responsibilities:

Created analysis datasets, tables and listings according to the guidelines and specifications of the client.

Created datasets in SDTM 3.1.1 format and created analysis datasets based on ADaM specification.

Created Analysis datasets, Tables, Listings for ISS and ISE.

Extensive interaction with the functional users to understand the requirements on statistical methods and measures

Worked on Phase I and II data. Some of the data used includes prescription data, sales rep activity data, and physician profile information

Produced data listings, summary tables and graphs

Designed flowcharts indicating the input data sets and the techniques that would be used (sorting, merging, etc.) to get the desired output

SAS was used for pre-processing data, SQL queries, data analysis, generating reports, and statistical analyses.

Generate statistical Analysis files, tables, listings and graphs

Received intensive training on the implementation of SDTM model to clinical trials.

Performed gap analysis using PROC CDISC to estimate CDISC compliance of current trial.

Performed CDISC mapping for current trials and classified data into domains such as Demographics (DM), Disposition (DS), Medical History (MH), Lab Test (LB) etc.

Environment: SAS/BASE, SAS/MACRO, SAS/SQL, SAS/STAT, SAS/GRAPH, SAS/CONNECT, SAS/ACCESS, MS-Excel, SAS/ODS, UNIX and Windows.

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