Statistical Programmer Programming

Keerthana V

Lead/Sr Statistical Programmer

E-mail: *********@*****.***

Phone: 984-***-****

SUMMARY:

Overall, 12+ years of SAS programming experience in the Pharmaceutical and CRO industries.

Extensively worked on Data mapping from Existing Raw data to CDISC SDTM Standard domains and reviewed CRFs (Case Report Forms) to ensure consistency with protocol and adequacy in collecting data to meet objectives defined in the protocol.

Extensive experience working with various SAS Modules like SAS/Base, SAS/Macros, SAS/SQL, SAS/Graph, SAS/Stat, SAS/ODS, SAS/Access, and SAS Enterprise Guide.

Expertise in SAS Programming with a statistical background in phases I, II, and III of clinical trials.

Extensive experience in generating SDTM datasets for Special Purpose Domains, Events, and Findings Domains from raw data sets by following CRF, Dataset Specifications, ADAM, and CDISCSDTM standards.

Collaborate with the study statistician and study team members to come up with timelines for statistical programming deliverables and other related action items.

Manage and supervise statistical programming resources, such as contractors and CROs, efficiently to make sure high-quality deliverables are on schedule and under budget.

Expertise in SAS Base, SAS/Macros, SAS/Graph, SAS/STAT, and reporting processes.

Expert in using SAS/ODS to create Ad-hoc RTF, HTML, PDF, and Listing output reports.

Extensively used various SAS procedures like Proc Transpose, Proc Univariate, Proc Summary, Proc Means, Proc Freq, Proc Tabulate, Proc Contents, Proc Sort, Proc Print, Proc Glm, Proc SQL, Proc GPLOT, and Proc GCHART.

Designed and developed datasets for ISS and ISE submissions in compliance with CDISC standards (SDTM and ADaM) and regulatory requirements.

Involved in the process of generating Tables/Listings for Integrated Summaries of Efficacy (ISE) and Safety (ISS) for FDA Submission.

Create and maintain specifications as per CDISC SDTMIG. Perform SAS programming to provide complex data review listings and reports to support Data Management and clinical teams.

Mentoring and Training the Team as per the Study requirement.

Creating, Evaluating, Validating, and running SAS programs that produce tables, figures, and listings.

Involved being the lead statistical programmer in addition to attending study team meetings. Performs as a statistical and programming resource for the development teams and communicates statistical issues.

Helped prepare PK/PD reports, including summary outputs and clinical study reports (CSR), for regulatory submission (e.g., FDA, EMA).

Created repeatable procedures to create study listings, tables, and figures (TLFs) for submission documents and PK/PD reports.

Creating QC Checklist for QA audits and attending the QA Audits before Study Submissions.

Attended the Study Meetings with Sponsors and discussed studies related to required documents and timelines.

Clearing Pinnacle 21 errors and Warnings.

Strong knowledge of CDISC standards, CDASH, SDTM, and ADaM.

Independently interact with Sponsors regarding statistical programming issues.

Independently and/or lead a team to create standard tools to improve the efficiency of programming tasks.

Worked on therapeutic areas like Oncology, Central Nervous System, Vaccines, Respiratory, Cardiovascular, COVID-19, Dermatology, and Autoimmune Disease.

Worked with different clinical trial data like Demographics (DM), Adverse Events (AE), Serious Adverse Events (SAE), Laboratory-chemistry/Hematology/Urine analysis, and Vital signs.

Proficient in Quality Control/Validation of analysis datasets according to SOP standards.

Expert in the creation of Define.XML for SDTM and ADaM.

Expert in Define BIMO FDA’s Bioresearch Monitoring Program

Involved in all CDISC projects, developed ADaM datasets as per specification and

referred protocol, SAP, and CRF.

Possess extensive knowledge in understanding Protocol, Case Report Forms (CRF),

Statistical Analysis Plan (SAP) and developing SDTM/ADaM datasets using Specs.

provided by statisticians and mentioned the CDISC-SDTM/ADaM Guideline rules.

Experience in Data Manipulation procedures such as SAS Formats/Informatics, Merge, Proc Datasets, Proc Sort, and Proc Transpose

Experience supporting FDA regulatory submissions.

Works as the Principal Statistical Programmer. Supervises the work of other programming team members and keeps updates on the status of programming deliverables.

Knowledge of CRF-Annotation used various database designs.

Experience in Python and R Programming in the Production of analysis, Tabulations, Listings, and Graphs from Clinical Trial Data.

Making efficient usage of SAS functions and Procedures, including common statistical procedures.

Excellent team player with the ability to work individually as well as in teams.

TECHNICAL EXPERTISE

SAS Tools

SAS 8.2/9.1.3,9.4 SASEG, SAS/BASE, SAS/STAT, SAS/MACRO, SAS/SQL, SAS/ACCESS, SAS/GRAPH, SAS/ODS

Operating Systems

Windows 98-2003, 2007/NT/XP/VISTA, UNIX

Languages

SQL, UNIX, C++, R

Database Management

SQL Server, Microsoft Access, Argus Safety

Office Software

MS Office (Word, PowerPoint, Excel, Access)

PROFESSIONAL EXPERIENCE:

Company: Eagle Eye Technologies JUN 2023 – TILL NOW

Client: Grail-Bio

Lead Statistical Programmer

Responsibilities:

Created a committee to monitor the data (Data Monitoring Committee) and submitted it to an 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 an employee went on 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.

Interacting with statisticians to resolve the issues related to SAP (Statistical Analysis Plan) and data managers, and others to resolve data issues in the conversion of SAS datasets into SDTM (Study Data Tabulation Model) and ADaM (Analysis Data Model) -compliant structures.

Assisted in authorizing and mapping specifications to convert clinical study data to Sponsor/ ADaM (Analysis Data Model) standards.

Analyzed and commented on study documents such as SAP, protocol.

Created Utilities and reusable Macros extensively used existing macros and developed SAS Programs for Data Cleaning, validation, analysis, and Report generation. Tested and debugged existing macros.

Created QC Programming for datasets and TFLs which helped to generate all log files into a single file which increased efficiency.

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

Participant in SOP and process development of the department

Trained and guided the new junior-level programmer and explained to them about Gilead Architecture, Macros, and other questions they might have.

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)

Designed and developed datasets for ISS and ISE submissions in compliance with CDISC standards (SDTM and ADaM) and regulatory requirements.

Strong knowledge in CDISC including SDTM, ADaM, metadata, controlled terminologies, and data flows, as well as in industry standards for electronic submission of data to FDA.

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

Wrote specifications for SDTM dataset creation.

Resolved various data issues by providing edit-check programs.

Lead a statistical programming team to complete a project within given timelines and budget.

Lead the studies/projects by coordinating with other programmers about data issues, tasks, and timelines.

Modified standard programs to generate data sets for statistical data analysis, and 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 maintaining existing ones.

Company: Symbiance Pharma Solutions Pvt Ltd Dec 2021 - Dec 2022

Client: Parexel, NC

Role: Lead/ Sr Statistical Programmer

Responsibilities:

Developed programs that convert raw SAS datasets into standard format and improve existing programs by creating standard programs and macros.

Mapped raw data to SDTM in compliance with CDISC data model standards as per the SDTM specification document.

Independently programmed CDSIC SDTM and ADaM datasets.

Validated SDTM domains using the SAS compare procedure and Pinnacle 21 tool.

Independently developed QC programs to validate peer programmers' SDTM domains, ADaM datasets, statistical tables, and listings.

Monitor project resourcing, project budgets, and identify changes in scope.

Organizing the team meetings to discuss timelines, specifications, and any data issues.

Worked on the Oncology therapeutic area and creation of CDISC data sets.

Worked with Managers, and Statisticians to create analysis datasets to generate safety and Efficacy reports for the various studies.

Mentoring and Training the Team as per the Study requirement.

Independently interact with Sponsors regarding statistical programming issues.

Strong knowledge in CDISC including SDTM, ADaM, metadata, controlled terminologies, and data flows, as well as in industry standards for electronic submission of data to FDA.

Generated Safety and Efficacy tables, and listings as per the requirement to support publications, data safety monitoring committee (DSMB) submissions, clinical study reports, and ad-hoc statistical analysis.

Participated in ISS and ISE programming activities, provided programming support, and reviewed submission-ready documents.

Independently and/or lead a team to create standard tools to improve the efficiency of programming tasks.

Reviewed Define.xml, analyzed data reviewers guide, and converted the format files to XPT format files using Proc Copy and EXPORT engine.

Written Edit checks to verify the data issues and implemented SAS edit check templates.

Worked on generating the ADaM datasets as per the analysis needs based on the ADaM specification file.

Provided SAS programming support to generate Safety reports such as a summary of adverse events, lab data summaries by visit and shift tables, abnormal vital signs summaries, and Efficacy tables not limited to progression-free survival, disease response summaries, and overall survival summaries.

Prepared safety listings related to DM, AE, MH, CM, EX, and VS domains.

Prepared tables like the summary of demographics, a summary of baseline characteristics, and a summary of disposition, related to DM.

Worked on outputs related to AE, MH, CM, EX, VS, LB, PK parameters, etc.

Company: Ecron Acunova Limited NJ Apr2021 – Nov 2021

Client: Novartis

Role: Sr Statistical Programmer

Responsibilities

Successfully designed and implemented statistical reporting processes for regular data collection and clinical data analysis.

Developed programs to prepare the safety and efficacy tables, listings, and graphs (TLG) required for the Clinical Trial Report (CTR) and the associated Analysis Data Sets.

Reviewed key planning documents (e.g., statistical analysis plan, data presentation plan, data review plan) to ensure alignment with development team objectives and clarity and completeness of programming assumptions and requirements.

Mentoring and Training the Team as per the Study requirement.

Creating Define BIMO Bioresearch Monitoring.

Created CDISC SDTM and ADaM datasets.

Analyzed raw data and provided input to Statisticians regarding analysis dataset specifications.

Develop SAS macros for use in clinical studies.

Mentoring and Training.

Creating a QC Checklist for QA audits.

Study meetings with Sponsors.

Provide technical support and advice to the internal and external team.

Learn new systems and functions in an evolving technical environment and provide the relevant training to the team.

Writing project-specific macros and initial study folder creation will be useful to understand the hierarchy of the study.

Responsible for the proper coding, documentation, and validation of SAS programs/macros/procedures to produce the standardized data display.

Performed verification of SAS-generated outputs (Table, Listings, and Graphs) via independent programming.

Established and maintained libraries of fully documented and validated SAS programs/macros/procedures that were used.

Collaborate with quantitative scientists (e.g., PK/PD, statistics, molecular epidemiology, ADME, modeling, and simulations) to integrate study development with illness progression and drug response models.

As part of the Clinical Pharmacology team, you will help synchronize Phase I and II clinical trials and organize submissions globally.

Ensured proper and consistent implementation and maintenance of guidelines and standards within the department.

Clearing Pinnacle 21 errors and Warnings.

Involved in activities of developing XPTs to run pinnacle and adding comments.

Involved in activities of developing GMF and clearing log warnings and errors.

Involved in the generation of SDTM and ADaM Reviewers Guide.

Performed data checks before database lock for the data management team.

Generated ad-hoc tables, listings using SAS/ODS and proficient in ODS RTF

Prepared TLGs and statistical outputs for analysis as per shells.

Attends QA internal and External Audits to Explain Project Complete details.

Generated Patient Profiles as per the requirement at the study level for special attention AEs.

Created datasets like Demographics (DM), exposure (EX), concomitant/prior medications (CM), adverse event (AE), disposition (DS), medical history (MH), Vital signs (VS), ECG (EG) Trial domains etc in SDTM Plus standards.

Created other study-specific datasets such as antineoplastic medications, antineoplastic surgeries, antineoplastic radiation, last alive data, tumor response, tumor identification, etc.

Worked on ADAM datasets such as ADSL, ADAE, ADCM, ADEG, ADDV, ADVS, ADLB, ADEX, PK-merge, RECIST, ADQS, ADQLQ, ADVENT, ADAETTE and ADTTE

Involved in sorting, printing, and summarizing the SAS Data, modifying and combining SAS datasets.

Worked on pooled studies.

Company: Navitas Life Sciences Feb 2019– Mar 2021

Client: Novartis, NJ

Role: Sr Statistical Programmer

Responsibilities

Successfully designed and implemented statistical reporting processes for regular data collection and clinical data analysis.

Developed programs to prepare the safety and efficacy tables, listings, and graphs (TLG) required for the Clinical Trial Report (CTR) and the associated Analysis Data Sets.

Reviewed key planning documents (e.g., statistical analysis plan, data presentation plan, data review plan) to ensure alignment with development team objectives and clarity and completeness of programming assumptions and requirements.

Collaborate with other quantitative scientists (e.g., PK/PD, statistics, molecular epidemiology, ADME, modeling, and simulations) to integrate study development and conduct with disease-progression and drug-disease response models.

Contribute, as an integral member of the Clinical Pharmacology team, to global alignment of Phase I and II clinical studies as well as submission planning activities

Collaborate with other functional areas (Global Patient Safety, PK/PD, ADME, Statistics, Tailored Therapeutics organization) in the development of methods for assessing special clinical safety pharmacology studies.

Mentoring and Training the Team as per the Study requirement.

Creating Define BIMO Bioresearch Monitoring.

Created CDISC SDTM and ADaM datasets.

Analyzed raw data and provided input to Statisticians regarding analysis dataset specifications.

Develop SAS macros for use in clinical studies.

Mentoring and Training.

Creating QC Checklist for QA audits.

Study meetings with Sponsors.

Writing project-specific macros and initial study folder creation will be useful to understand the hierarchy of study.

Responsible for the proper coding, documentation, and validation of SAS programs/macros/procedures to produce the standardized data display.

Clearing Pinnacle 21 errors and Warnings.

Involved in activities of developing XPTs to run Pinnacle and adding comments.

Involved in activities of developing GMF and clearing log warnings and errors.

Involved in the generation of SDTM and ADaM Reviewers Guide.

Performed data checks before database lock for the data management team.

Generated ad-hoc tables, listings using SAS/ODS and proficient in ODS RTF

Company: Icon Clinical Research June 2017 – Jan 2019

Client: Novartis, NJ

Role: Sr. SAS Programmer

Responsibilities:

Responsible for preparing study-level specs for the dataset using CDISC STDM standards.

Mapped and standardized raw datasets for legacy datasets according to the CDISC SDTM Model.

Developed programs to generate analysis datasets (created ISO date character variables).

Performed CRF SDTM annotations and CDISC Controlled Terminology Management.

Mentoring and Training the Team as per the Study requirement.

Update standard macros based on raw data and mapped complex data as per the guidelines provided.

Reviewed and commented on Protocol, Annotated Case Report Form (CRF), Controlled Terminology, and raw datasets for all studies assigned.

Involved in the creation of analysis data sets, tables, listings, and figures.

Developed and validated Oncology-Specific domains of Tumor Identification (TU), Tumor Results (TR), and Disease Response (RS) and their respective ADaM domains.

Experience with applications of population PK/PD, modeling and simulation, and model-based drug development into clinical development plans.

Extensive Knowledge of electronic submission standards

Program development in support of CSR and ADHOC requests from Clinical with emphasis on meeting regulatory requirements for TLFs, uniformity, and program compatibility.

Generated Listings and reports for presenting the findings of various statistical procedures using procedures like PROCREPORT, PROC FREQ, PROC LIFETEST, PROC MIXED, and SAS ODS.

Used SAS ODS facility to create HTML, RTF, and PDF output files in the process of creating reports.

Extensively involved in peer validation of SAS programs and programmed edit checks to reporting consistencies and discrepancies in the database.

Pulling the study-specific raw data sets from the Rave database for data cleaning and report generation.

Writing project-specific macros and initial study folder setup, which will be useful to understand the hierarchy of study.

Performed Data Validation and Data cleaning by Peer-Reviewing.

Wrote Quality Control programs for various reporting stages and generated analysis datasets, Tables, Listings, and Graphs.

Performed validation activities to ensure the quality of the electronic submission and contributed towards creating Tables and listings and validating the analysis datasets as per the Data Specifications.

Performed ad hoc programming as per client’s requests.

Company: United Health Group, India Jan 2012 – June 2017

Role: Statistical Programmer

Responsibilities:

Extensive experience in CDISC SDTM with Med DRA dictionary coding/decoding skills and mapped the SAS data into SDTM which helped in the Feasibility of Electronic Submissions.

Supported non-technical users to prepare CRF and SAP according to the protocol requirements.

Involved in reviewing the study protocol and case report form (CRF) and performing validation of clinical trial data to identify the error entries.

Mentoring and Training the Team as per the Study requirement.

Supported Industry standards for design by the Clinical Data Interchange Standards Consortium (CDISC)

Successfully designed and implemented statistical reporting processes for regular data collection and clinical data analysis. Supported programming activity for Clinical trials of Dermatology and Hematology.

Involved in creating SAS Programs for the validation of tables in drug studies.

Generated reports in compliance with 21 Code of Federal Regulations (21CFR) part I, FDA, data transmission and integrity check for the Clinical trial systems

Developing SDTM Domains based on SDTM IG 3.1.2 and 3.2.

Excellent team player with the ability to work individually as well as in teams.

Generating reports by using procedures like Proc Sort, Proc Means, and Proc Report.

Data step programming with SAS functions mainly INPUT, PUT, SUBSTR, INDEX, SCAN, SET, MERGE, and BY group processing for data manipulations.

Modified the existing SAS datasets using the set, merge, sort, and update functions.

EDUCATION QUALIFICATION:

Master’s in Management Information Systems (MSMIS), AUBURN UNIVERSITY AT MONTGOMERY, Alabama AL (Jan-2023-May-2024).

Bachelor of Science B Pharmacy, PRRM College of Pharmacy INDIA passed out in 2011.

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