Clinical Research Data Management

Beena Josephine Rajeshwaran Email id: ********@*******.***

BASE SAS certified. Contact No:414-***-****

Location: Wallingford, CT

Summary

Analytical and highly organized biostatistics professional with over 12 years of experience in clinical research, clinical trials, and pharmaceutical development. Proven expertise in statistical analysis, CDISC standards, ADaM/SDTM datasets, and clinical reporting. Strong command of SAS, R, and Python with a solid foundation in statistical methodologies Adept at cross-functional collaboration, statistical programming, and deriving data-driven insights to support decision-making in clinical development. analyses.

SKILLS

Statistical Analysis: Hypothesis Testing Survival Analysis Kaplan-Meier plots Experienced in P-value interpretation using a variety of statistical tests, including Chi-square, Fisher’s Exact Test, Mantel-Haenszel, and Cochran-Mantel-Haenszel (CMH) methods and categorical data analysis GLM/Logistic Regression Tools & Languages: SAS (BASE, Macro) R Python SQL

Data Standards: CDISC SDTM PK/PD modeling support ADaM NONMEM NM-TRAN format datasets Define.xml, Pinnacle21 Reporting: TLFs, Clinical Study Reports (CSRs) Summary Tables Graphs

Therapeutic Areas: Oncology Pulmonology Hematology Neurology Other: Protocol Review SAP Support Cross-functional Communication Mentorship Regulatory Submissions.

PROJECT (Python- MS Biostatistics)

I have completed Python projects as an elective in my MS Biostatistics program for Spring 2025:

Machine Learning in Python:

Imaging projects with K-means clustering, noise reduction.

Prediction: KNN classifier to predict the severity of COVID-19.

2D convolutional neural network binary classifier

Used various data sources like csv, txt files etc

Experience

Safety and Efficacy

Principal Programmer Sep 2024 – Current

Client: R2Technology

Developing/validating and maintaining SAS programs to generate analysis datasets, biomarker datasets, tables, listings, and figures.

Working closely with data management and statistical teams to understand the requirements for each project

Creating and maintaining documentation for all SAS programs and processes

Contributing to the development of standard operating procedures, guidelines, and best practices for SAS programming

Vita Global Science Jan 2024- July 2024

Manager Statistical Programming

Served as a study lead for multiple projects collaborated with the vendors, Data Management and Biostats team to meet the project deliverables and timelines for Statistical Data analysis and reporting. Leading a study team of 8 to 10 programmers and efficiently managing the resource allocation across the studies. Independently review all the deliverables and help the team technically as well to meet the deliverables. Trained the team on technical aspects. Communicate clearly on the resource needs and budget to the Management.

Responsible for the production and validation of programming deliverables, SDTM specification, ADaM datasets specification, dataset review and reports including Biomarker datasets.

Provided feedback and key-point to CRF, SAP, Protocol and Mock shell.

Ensure that all the process has been adapted as per the SAP, Protocol, Clinical standards and regulatory requirements.

Independent program to validate SDTM/ADaM specifications, datasets and reports.

Contributing to the development of global standard macros. Provided programming support for submissions.

Worked on Biomarker, Pharmacokinetic domains (PK/PD) PP, PC, ADPC datasets.

Expertise in generating NONMEM datasets, including NM-TRAN format datasets for pharmacokinetic and pharmacodynamic modeling, Longitudinal concentration datasets incorporating covariate effects,

Dosing history datasets for simulation studies in NONMEM, Covariate datasets integrating demographic, laboratory, and genetic data for population PK/PD modeling.

Involved in Validating ADaM datasets using R.

Worked on the SDRG/ADRG, Define metadata, Define.xml, addressed P21 issues.

Served as CDISC SDTM SME.

Worked extensively on Pulmonary studies. Extensively handled Biomarker datasets.

Extensively worked on Ad hoc request and delivered with quality on time.

Communicate with the vendor on the data discrepancies, timeline and expectations.

Communicate with the Biostatistician to discuss statistical inferences, render training and guidance.

Jazz Pharmaceuticals April 2022 – Nov 2023

Principal Statistical Programmer (Manager)

Create or review and approved CDISC compliant datasets and corresponding documentation for electronic submission to regulatory agencies. Create or review and approve programming plans at study and project level.

Leading multiple studies efficiently managing a team of 5 to 6 programmers (FSPs) per study. Efficiently managed vendors worked with Cross-functional departments to meet out the timeline.

Reviewed CRFs, SAP, Shells and provided inputs.

Worked extensively in Neuroscience Phase 2 and Phase 3 studies on muscular spasm, sleep disorder, Hematology studies as a study lead with Hands on programming experience.

Participated in ISS submissions.

Provided input on key study-related documents produced by other functions (e.g. CRFs, Data Management Plan, SAPs, etc.).

Involved in ADaM dataset programming using R.

Involved in ISS submission

PPD Inc April 2017 - April 2022

Senior Programmer Analyst II

Served as a Study Lead for several multiple therapeutic areas, provided expertise as needed for the project, ensured the team is following the CDISC guidance for SDTM and ADAM programming and spec development activities. Developed SDTM and ADaM specifications following the CDISC guidance, developed and qc’ed the datasets and TLFs for Phase 2 and Phase 3 studies for CKD, Hematology, Ophthalmology, Oncology etc.

Supported Pharma and Biotec clients such as GSK, Takeda, Celgene, Array, Incyte

Developed macros for the study team to make work more efficient.

Supervised, trained and mentored junior programmers. Provided training on Annotating the CRF, SDTM, ADaM spec writing/review, P21 issues and CDSIC standards.

Developed Waterfalls plots, spider plots for BOR and KM plots for Survival Analysis in Oncology studies using PROC SGPLOT and PROC LIFETEST.

Worked as a point of contact for the Client and Vendors.

Initiated a recognition program within my organization and won the “Difference Maker Award”.

Won “Spot Award” for my projects for my proactive work and suggestions.

Written a paper on how to build the relationship between the CRO and Sponsor programmers which got published in PHUSE 2020.

Got award as “SDTM expert” for my contribution towards the project team.

PAREXEL International February 2016 - April 2017

Senior Statistical Programmer

Independently validated and developed SDTM/ADaM datasets and TLFs as per CDISC compliance. Coordinated and led a statistical programming team to successfully completion of a study within given timelines and budget. Monitored project resourcing, project budgets and identified changes in scope. Proved technical support and guidance to the internal team. Interacted with sponsors as the key contact with regards to statistical programming issues.

Delivered best value and high-quality service.

Developed oncology-specific domains (TU, TR, RS, ADRS, ADTR) to create TLFs for overall survival rate and progression-free survival.

Adhered to CDISC standards in Developing/QC ADAM specifications, datasets and TLF for Oncology Phase 2 and 3 studies of small cell Lung cancer studies.

Got recognition awards from my manager and peers for the qualities and achievements below.

Teamwork award in April 2016.

“I own the problem and the solution” Award on January 2017.

“I delight the customer for Project management” Award on January 2017.

Recognized by my peers and juniors for my mentorship, efficient time management.

Initiated SOP for documentation on the study activities.

Lead several complex studies and stirred in the correct direction to achieve the timeline with high quality for which I was given the” defining principal award”

ICON Clinical Research June 2012 - November 2014

Clinical Data Programmer

Annotated CRFs in accordance with CDISC published or sponsor specific guidelines with appropriate metadata to reflect case report tabulation (CRT) data sets. Established and maintained study documentation as required, in accordance with SOP.

Created SDTM specifications per specified study requirements. Programmed SDTM data sets per specification. Validated SDTM data sets per the formal, documented QC process.

Executed programs and generated clinical data outputs according to study/client requirements.

Used ICON’s SDM tool to generate SDTM datasets which generate SQL codes.

Delivered data dumps for Clinical Data Management before database lock.

Created simple and reusable Macros and extensively used existing macros.

Played Study Lead role in mentoring the juniors to meet the project timelines,

Managed to give quality deliverables for several Adhoc requests.

Completed most of the project before deadlines and delivered to Biostats and sponsors submissions.

Handled many Ad-hoc Deliverables. Got appreciation for my quick turnaround and early completion of projects.

Was given the "ICO CHAMP" award for dedication.

CYTEL Software Company June 2011 - May 2012

Junior Statistical Programmer

Developed SDTM and Analysis Datasets, validating ADAM datasets and SDTM datasets, listings and generating reports.

Experienced in CNS, Oncology, and HIV therapeutics.

Independently Worked on Lab datasets,

Worked in Efficacy Analysis, Statistical Analysis such as Kaplan Meier, P-value for the data.

Extensively handled in-house macros

Education

Master of Science (MS) Biostatistics

University of Louisville, Kentucky (2023-2026)

PGDS (Post Graduate Program in Data Science)

Purdue University (2021-2022)(ML, AI projects using R, Python and Tabulae)

Master of Science (MS), Actuarial Science

Bishop Heber College

Affiliated Bharathidasan University, Trichy, TN, India

Bachelor's in Computer Application (BCA)

Kurinji College of Arts & Science

Affiliated Bharathidasan University, Trichy, TN, India

Publications

Common Misconceptions from Sponsor’s and CRO’s Programmers & Their Challenges

Yan Wang, Beena Rajeshwaran, Robert Bandy

PHUSE Connect US 2020 International Conference.

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