SRINIVASAN RAMANUJAM

CLINICAL SAS PROGRAMMING

848-***-****

EMAIL ID: ac1brb@r.postjobfree.com

Profile:

● 16 Years of Total Industrial Experience

● 14.5 Years of IT Experience

● 13 Years of Clinical SAS Experience

Summary:

● Experience in Clinical Data Analysis, Producing Reports, Listings, Tables, Graphs, and Summaries from clinical trial data for various phases of Clinical Trials.

● Worked with different clinical trials data like Demographic, Adverse Event (AE), Serious Adverse Event (SAE), Laboratory-chemistry/Hematology/Urine analysis, Vital signs, etc.,

● Modification of existing SAS programs and creation of new programs using SAS Macros to improve ease and speed of modification as well as consistency of results.

● Experienced in producing External files and customized reports using various SAS procedures like Proc Report, Proc Print, Proc tabulate, Proc Means, Proc Freq, Proc Univariate, Proc SQL, Proc Transpose and Data _Null_ Technique

● Experienced in producing RTF, HTML and PDF formatted files using SAS /ODS to produce adhoc reports for Analysis Reports

● Producing Safety and Efficacy analysis.

● To comparing Means of two drugs (New drug with Existing) by using Proc T-Test(Paired and Unpaired ), Chi-Sq and Fisher exact Tests .

● Generating Descriptive Statistics (N, Mean, Std, Median, Range) by SAS/ BASE procedures like Proc Tabulate, Proc Means and proc Univariate etc.,

● Merging the datasets by using Merge statement.

● For getting required output format by using Proc Transpose, Proc Sort, Proc tabulate ...etc.

● Cleaning the dataset’s by using Base SAS Procedures and Data Steps.

● Creating final report format by using Proc Report.

● Applying desired client specifications to final report dataset.

● Following Statistical Analysis Planning and bio-Statistician guidance during the project.

● Checking final output values with QC.

Technical Skills:

SAS Skill : SAS/BASE, SAS/STAT, SAS/SQL, SAS/MACROS, SAS/ACCESS Therapeutic Areas: Oncology, Anti-virology, CNS and Gastroenterology Operating Systems : Windows, UNIX

Education:

● Bachelor of Engineering in Production Engineering, Bharathidasan University, India, 2001 Professional Experience:

IBM Watson

Lead - Clinical SAS Programming Jan’17 - Jun’17

Responsibilities:

● Generate safety (Adverse Events, Safety adverse events, Treatment emergent adverse events, Demographics, Vital Signs and Laboratory Findings) and efficacy tables using Proc Report.

● Create datasets according to CDISC SDTM.

● Involved in the production and QC of analysis plans, TLF mock-shell development, derived dataset specifications, programming specifications, and other process supporting documents.

● Used regulatory requirements concerning industry technical standards (e.g., CDISC, 21 CFR Part 11, electronic submissions, etc.) and implications for the department.

● Work on creating analysis datasets, defined variables of interest, study populations, visit window and baseline observations.

● Generated Descriptive and Statistical summary outputs using Proc Means, ProcFreq, ProcUnivariate and Proc Summary etc.

● Created complex and reusable Macros and extensively used existing macros and developed SAS Programs for Data Cleaning, Validation, Analysis and Report generation. Tested and debugged existing macros.

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

● Generated Tables, Graphs and Listings for inclusion in Clinical study reports and regulatory submission and participated in preparing study results as well as ISS and ISE for FDA submissions using SAS.

● Assisted Bio-statistician in computing different statistics using PROC TTEST, PROC FREQ (chi-sq& fisher), PROC ANOVA, ProcReg and PROC MIXED etc.

● Generated RTF, HTML and PDF outputs for clinical study reports and Integrated summaries for regulatory submissions.

● Familiar with ICH, GCP guidelines and Electronic Submission standards.

● Used SAS/Graph procedures like ProcGchart and ProcGplot for graphical presentation of the statistical analysis.

● Provide support to and mentor junior programmers and contractors. HIGHLIGHTS:

● Bagged Prestigious Award for taking part in Product Development for safety tables under very tight deadlines and highly critical business climate

● Diligently developed the Process Improvement Plan and imparted training programs for the entire team including onshore

Environment:Base SAS, SAS/Stat, SAS/Macros, SAS/Graph, SAS/Access, Windows / UNIX Truven Health Analytics India Pvt. Ltd. Jan’13 to Dec’16 Lead - Clinical SAS Programming

Responsibilities: Same as above as IBM acquired Truven Health Analytics Thomson Reuters, India Jun’10 to Dec’12

Lead - Clinical SAS Programming

Responsibilities: Same as above as Truven Health acquired Thomson Reuters healthcare Infosys Technologies Limited, India Dec’09 to Jun’10 Technology Lead - Clinical SAS Programming

Responsibilities:

● Involved in understanding the Protocol, Statistical Analysis Plan (SAP) and Annotated CRF.

● Independently develop and validate programming specifications for creating SDTM datasets by using CDISC Standards.

● Independently develop and validate programs that generate SDTM datasets by using CDISC Standards.

● Worked extensively on various SDTM domains such as Interventions – Exposure (EX), Comments (CM), Substance use (SU), Events - Adverse Events (AE), Medical History (MH), Disposition (DS), Clinical Events

(CE), Protocol Deviation (DV), Findings – (EG), LB, IE and Vital signs (VS).

● Worked on Special Purpose Domains like Demographics (DM), Subject Elements (SE), Subject Visits (SV), Comments (CO) & their SUPPQUAL datasets.

● Provided data in SAS transport files, other appropriate deliverables, and documentation for regulatory submissions by using PROC COPY and PROC CPORT with Xport engine.

● Participated in designing define.xml based on CDISC standard.

● Modified existing programs and created new programs using SAS macro variables to improve easy and speed of modification as well as consistency of results.

● Perform data checks as needed, to ensure integrity and correctness of data displays. Prepare documentation for programs.

● Project managing work load to ensure study deliverables are met to a high quality and timely fashion.

● Maintain complete and auditable documentation of all programming activities.

● Develop, apply and promote consistent programming standards through standard processes and SOPs.

● Handle miscellaneous tasks as assigned by management.

● Provide support to and mentor junior programmers and contractors.

● Good Exposure on Clinical Trial (I – II – III) Phases. Environment:Base/SAS, SAS/Stat, SAS/Graph, SAS/SQL, SAS/ODS, SAS/Macro, MS Excel, MS Access, Windows XP.

Accenture Services Private Limited, India Jan’08 to Dec’09 Team Lead – Clinical SAS Programming

Responsibilities:

● Involved in understanding the Protocol, Statistical Analysis Plan (SAP) and Annotated CRF.

● Perform data checks as needed, to ensure integrity and correctness of data displays. Prepare documentation for programs.

● Independently develop and validate programs that generate safetyand efficacy tables, listings, figures/graphsbased on Protocol SAP.

● Developing and implementing SAS programs to produce descriptive and statistical analyses, summary tables, data listings and graphs.

● Actively participated in ISS/ISE integration for various studies.

● Used several Base SAS procedures likeProc MEANS, Proc SUMMARY, Proc FREQ, Proc TABULATEandProc UNIVARIATE.

● Developed efficacy analysis/ derived datasets implementing LOCF, visit windowing based on duration of treatment and other data transformations as specified by the Statistical Analysis Plan (SAP).

● Modified existing programs and created new programs using SAS macro variables to improve easy and speed of modification as well as consistency of results.

● Provide statistical programming support to supplemental or exploratory analyses for regulatory agencies or any other internal and external ad-hoc requests.

● Generated highly customized reports using ProcFormat,ProcReport,Proc Tabulateand ODS HTML.

● Developed validated and maintained SAS programs for validation, manipulation, analysis and reporting of large volume of data as per the business requirements.

● Used SAS/Graph procedures like ProcGchartandProcGplot for graphical presentation of the statistical analysis.

● Created RTF, PDF and HTML reports by using the SAS Output Delivery System.

● Ensure programming deliverables are consistent and comply with study protocols, statistical analysis plans and case reportsforms.

● Extensively used Proc SQL queries to maintain datasets.

● Maintain complete and auditable documentation of all programming activities.

● Good Exposure on Clinical Trial (I - II - III) Phases. Environment:Base/SAS, SAS/Stat, SAS/Graph, SAS/SQL, SAS/ODS, SAS/Macro, MS Excel, MS Access, Windows XP.

Tata Consultancy Services, Chennai, India Aug’06 to Dec’07 Clinical Statistical Analyst - SAS

Responsibilities:

● Involved in understanding the Protocol, Statistical Analysis Plan (SAP) and Annotated CRF.

● Independently develop and validate programming specifications for creating SDTM datasets by using CDISC Standards.

● Independently develop and validate programs that generate SDTM datasets by using CDISC Standards.

● Worked extensively on various SDTM domains such as Interventions – Exposure (EX), Comments (CM), Substance use (SU), Events - Adverse Events (AE), Medical History (MH), Disposition (DS), Clinical Events

(CE), Protocol Deviation (DV), Findings – (EG), LB, IE and Vital signs (VS).

● Worked on Special Purpose Domains like Demographics (DM), Subject Elements (SE), Subject Visits (SV), Comments (CO) & their SUPPQUAL datasets.

● Provided data in SAS transport files, other appropriate deliverables, and documentation for regulatory submissions by using PROC COPY and PROC CPORT with Xport engine.

● Participated in designing define.xml based on CDISC standard.

● Modified existing programs and created new programs using SAS macro variables to improve easy and speed of modification as well as consistency of results.

● Perform data checks as needed, to ensure integrity and correctness of data displays. Prepare documentation for programs.

● Project managing work load to ensure study deliverables are met to a high quality and timely fashion.

● Maintain complete and auditable documentation of all programming activities.

● Develop, apply and promote consistent programming standards through standard processes and SOPs.

● Handle miscellaneous tasks as assigned by management.

● Provide support to and mentor junior programmers and contractors.

● Good Exposure on Clinical Trial (I – II – III) Phases. Environment:Base/SAS, SAS/Stat, SAS/Graph, SAS/SQL, SAS/ODS, SAS/Macro, MS Excel, MS Access, Windows XP.

Stira Pharma Solutions, Chennai, India Oct’05 to Aug’06 Clinical SAS Programmer

Responsibilities:

● Involved in understanding the Protocol, Statistical Analysis Plan (SAP) and Annotated CRF.

● Perform data checks as needed, to ensure integrity and correctness of data displays. Prepare documentation for programs.

● Independently develop and validate programs that generate safetyand efficacy tables, listings, figures/graphsbased on Protocol SAP.

● Developing and implementing SAS programs to produce descriptive and statistical analyses, summary tables, data listings and graphs.

● Actively participated in ISS/ISE integration for various studies.

● Used several Base SAS procedures likeProc MEANS, Proc SUMMARY, Proc FREQ, Proc TABULATEandProc UNIVARIATE.

● Developed efficacy analysis/ derived datasets implementing LOCF, visit windowing based on duration of treatment and other data transformations as specified by the Statistical Analysis Plan (SAP).

● Modified existing programs and created new programs using SAS macro variables to improve easy and speed of modification as well as consistency of results.

● Provide statistical programming support to supplemental or exploratory analyses for regulatory agencies or any other internal and external ad-hoc requests.

● Generated highly customized reports using ProcFormat,ProcReport,Proc Tabulateand ODS HTML.

● Developed validated and maintained SAS programs for validation, manipulation, analysis and reporting of large volume of data as per the business requirements.

● Used SAS/Graph procedures like ProcGchartandProcGplot for graphical presentation of the statistical analysis.

● Created RTF, PDF and HTML reports by using the SAS Output Delivery System.

● Ensure programming deliverables are consistent and comply with study protocols, statistical analysis plans and case reportsforms.

● Extensively used Proc SQL queries to maintain datasets.

● Maintain complete and auditable documentation of all programming activities.

● Good Exposure on Clinical Trial (I - II - III) Phases. Environment:Base/SAS, SAS/Stat, SAS/Graph, SAS/SQL, SAS/ODS, SAS/Macro, MS Excel, MS Access, Windows XP.

Prithvi Systek Consultants, Chennai, India Sep’04 to Sep’05 Clinical SAS Programmer

Responsibilities:

● Involved in understanding the Protocol, Statistical Analysis Plan (SAP) and Annotated CRF.

● Independently develop and validate programming specifications for creating SDTM datasets by using CDISC Standards.

● Independently develop and validate programs that generate SDTM datasets by using CDISC Standards.

● Worked extensively on various SDTM domains such as Interventions – Exposure (EX), Comments (CM), Substance use (SU), Events - Adverse Events (AE), Medical History (MH), Disposition (DS), Clinical Events

(CE), Protocol Deviation (DV), Findings – (EG), LB, IE and Vital signs (VS).

● Worked on Special Purpose Domains like Demographics (DM), Subject Elements (SE), Subject Visits (SV), Comments (CO) & their SUPPQUAL datasets.

● Provided data in SAS transport files, other appropriate deliverables, and documentation for regulatory submissions by using PROC COPY and PROC CPORT with Xport engine.

● Participated in designing define.xml based on CDISC standard.

● Modified existing programs and created new programs using SAS macro variables to improve easy and speed of modification as well as consistency of results.

● Perform data checks as needed, to ensure integrity and correctness of data displays. Prepare documentation for programs.

● Project managing work load to ensure study deliverables are met to a high quality and timely fashion.

● Maintain complete and auditable documentation of all programming activities.

● Develop, apply and promote consistent programming standards through standard processes and SOPs.

● Handle miscellaneous tasks as assigned by management.

● Provide support to and mentor junior programmers and contractors.

● Good Exposure on Clinical Trial (I – II – III) Phases. Environment:Base/SAS, SAS/Stat, SAS/Graph, SAS/SQL, SAS/ODS, SAS/Macro, MS Excel, MS Access, Windows XP.

Mikas Technologies, Trichy, India Jan’03 to Aug’04 Software Engineer

● Worked as a web designer using ASP programming with SQL as the backend process Shri Narmatha Fabricators, Trichy, India Jul’01 to Dec’02 Production Engineer

● Worked as a production engineer in a fabrication industry

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