Data Manager

Gaurav M.

Lead SAS Programmer

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

SUMMARY:

Lead/ Sr. SAS programmer with 9 years of experience in providing quality products and an active member adept at developing and implementing various SAS applications in the pharmaceutical industries and CRO. Skills includes thorough knowledge of Clinical trials (Phase I to IV), Randomization process, case control and cohort studies, trail execution, data capture, data manipulation, statistical analysis and data reporting. In depth knowledge of clinical trial domains such as Vital Signs (VS), Adverse Events (AE), Demographic data (DM), Medical History (MH), Disposition data (DS), Laboratory data (LB) and other related Safety and efficacy related data. Working experience in therapeutic areas such as gastro intestinal disorders, oncology, cardiovascular disorders, cirrhosis of liver, etc.Excellent work experience of implementing CDISC SDTM (Study Data Tabulation Model) for special purpose, events, findings, intervention and trial domains and implementing ADAM(Analysis Data Model). Well versed with 21 CFR Part 11 compliant Statistical Process Control Systems, International Conference on Harmonization (ICH) guidelines and Good Clinical Practice (GCP) and Coding Dictionaries such as MedDRA and WHO Drug. Actively involved with data management team and statistician to analyze clinical trial data and to program integrated summaries (ISE and ISS), FDA, IND, submissions. In-depth work experience in generating tables, listings, and graphs(TLF) by following the Statistical Analysis Plan(SAP), Standard Operating Procedures(SOP), and departmental guidelines.Proficient in exporting generated outputs to other environments or the web using various SAS method like create delimited, text files, ODBC Generated output files in RTF, HTML, and PDF format using SAS ODS.Ability to Work under Pressure, Self-starter, self-motivated, able to interact with individuals at all levels and highly adaptive to a fast team environment

Technical Proficiency:

SAS Products

Base SAS, SAS/MACRO, SAS/ODS, SAS/ACCESS, SAS/GRAPH, SAS/CONNECT, SAS/STAT SAS/SQL and PL/SQL

SAS Procs

Proc Print, Proc Means, Proc Report, Proc SQL, Proc Tabulate, Proc Freq, Proc Sort, Proc Anova, Proc Mixed, Proc Npar1way,Proc Lifetest,proc Gplot, proc Gchart, etc.

Languages & Tools

SQL, PL/SQL, Perl, C, C++, MS-OfficeSDTM (SDTMIG 3.1.3,3.2), ADAM

Scripting

Unix Shell scripting

Programming

SAS,EG,Unix, R, SPSS

Education:

Bachelor in Dental Science, Ahmedabad, India

Master of Public Health, (BIOSTATISTICS as a CORE) University of Illinois, Illinois, USA

Professional Experience:

Confidential.

Jul’ 2016 - Current

Lead SAS Programmer

Responsibilities:

Created a committee to monitor the data (Data Monitoring Committee) and submitted to unbinding team.

Participated as required at all meetings, discussions and activities covering aspects of Statistical Reporting on trial/project level activities with CDMA, Biostatistician, Clinical trial manager and clinical program Manager

Extracted data from Oracle; worked on the raw data and created analysis data sets according to CDISC SDTM standards using SAS procedures like Proc Means, Proc Freq, Proc Reg, Proc Sort etc.

Helped other teams and my teams in delivering the project in particular deadline when employee went for vacation

Annotated the CRF (Case Report Form) hard copy as per the need identified LABELS, TYPE & FORMAT and mapped them with the variables from the raw data sets.

Created complex and reusable Macros, used existing Macros, developed SAS Programs for Data cleaning, Data validation, Data analysis and Report generation.

Analyzed and communicated with medical team members and other department stake holders.

Analyzed and commented on study documents such as SAP, protocol

Created Utilities 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.

Created comparison programs for datasets and TFLs which helps to generate all log files in to single file which increased efficiency.

Transferred the raw data folder to CDO folder and modified it according to the requirement. Ran the script every time after a data cut

Trained and guided the new junior level programmer and explained them about Gilead Architecture, Macros and other question they might had.

Confidential.

Jun’2014- Jun’ 2016

Sr. SAS Programmer

Responsibilities:

Worked on Data Analysis of Phase II and Phase III Clinical trials on oncology studies, responsible for providing the biometrics team with programming support and producing safety and efficacy tables.

Created SDTM and CDISC datasets for phase I studies. Read in and reconciled electronic data with the CRF.

Developed tables listing and graphs (TLG) necessary for developing Clinical Trial Report (CTR) and Analyses Data Set (ADS)

Actively involved with data management team and statistician to analyze clinical trial data and to program integrated summaries (ISE and ISS), FDA, IND, submissions

Wrote specifications for SDTM dataset creation.

Performed QC of datasets, DDDs, a CRF to ensure their accuracy and that they meet the client specifications

Resolved various data issues by proving edit check programs

Modified standard programs to generate data sets for statistical data analysis, generate listings, summaries, tables, graphs and reports for analyzing clinical trial data results in compliance with relevant SOPs as per SAP.

Formatted HTML, XML, RTF and PDF reports, using SAS Output Delivery System (ODS).

Created datasets by combining different data sets using dataset merging techniques for SAS/BASE and using different inner and outer joins in SAS/SQL

Developed routine SAS macros and used departmental macros to create tables, graphs and listings for inclusion in Clinical study reports and regulatory submissions and maintained existing ones.

Confidential.

Dec’2012-May’ 2014

Sr. SAS Programmer

Responsibilities:

Worked as a SAS programmer to analyze initial data sets and create listings and Tables (TLs) for clinical trials. Using Proc Freq, Proc Tabulate, Proc Report, Data _null_

Modified existing datasets using Set, Merge, Sort, Format Techniquesand DATE, TIME Functions in accordance with CDISC and SDTM standards.

Worked on different clinical data such as adverse events (AE), serious adverse events (SAE), demographic (DM), vital signs (VS)

Converted MS-Word documents and EXCEL tables into SAS data sets.

Conducted documenting and reporting computer validation inspections in compliance with 21 Code of Federal Regulations (21CFR) and other regulatory compliance.

Worked on Pivot tables and VBA to write macros in Excel.

Generated analysis datasets and performed statistical reports as per SAP and DDT

Responsible for creation of Analysis/Submission datasets using set, merge, sort, update, format procedures/statements

Extensively involved in Clinical Data Analysis and preparation of SAS datasets, reports, tables, listings, graphs and summaries according to the Standard Operating Procedures (SOPs) and departmental guidelines.

●Worked with statistical quality assurance group and program validation for each project. Responsible for cleansing, formatting and loading the data into the database, Microsoft SQL server

●Expert in Creation of SDTM domain specifications and applying Mapping logic

●Validated other programmers code when asked for

●Generated HTML, PDF and RTF reports as per the requirement

Confidential.

Sep’09– Nov’ 2012

Sr. SAS Programmer

Responsibilities:

Performed statistical Analysis, created TLFs using SAS procedures such as Proc Report, Proc Tabulate, Data _null_, and Proc Freq

Created SDTM data specification tables with reference to CDISC standards

Worked on clinical trials data such as Demographics (DM),Vital Signs (VS), Disposition (DS), Adverse Events (AE), Physical Examinations (PE), and Laboratory (LB)

Created CRT’s (Case Report Tabulations) using CDISC standards for submissions to the FDA.

Produced SDTM and ADAM data sets by combination of two datasets in either SAS/BASE (merge by)or SAS/SQL (outer and inner join)

Worked on SDTM data mapping and confirmed the variables according to the variable

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

Created Macro and SAS programs to import external raw data file (EXCEL, Access, Oracle) in SAS environment

Used SAS Procedures like Proc Print, Proc Means, Proc Freq, Proc Summary, Proc Sort, Proc Transpose, Proc SQL for generating reports

Was responsible for generating E submission support files (PDF files) for monthly reports

Generated Analysis Datasets with the derived variables and performed analysis on the data as per the data definition table (DDT) and statistical Analysis Plan (SAP)

Attended team meetings and discussions, with team members, biostatisticians and data managers

Extensively worked on Data mapping from Existing Raw data to CDISC SDTM Standard and review CRFs (Case Report Form) to ensure consistency withprotocol and adequacy in collecting data to meet objectives defined inprotocol.

Conducted documenting and reporting computer validation inspections in compliance with 21 Code of Federal Regulations (21CFR) and other regulatory compliance.

Expertise in applying mapping logic and Involved in creation of CDISC SDTM Domains Specification and DataDefinition (Define.xml) Documents.

Created, validated, documented and maintained libraries of SAS application programs, formats and macros.

Developed utility macros for standard reports and validations.

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