Maria Thomas Email & Phone Number

Franklin Township, Nj, Us

Franklin Township, Nj, Us

Plainsboro , New Jersey , Us

• Strong experience working with clinical trial data on different therapeutic areas including Immunology, Hematology, Dermatology across phase I-III studies.• Performed multiple in-house programming activities such as CSR programming, regulatory filings, ad-hoc analysis, publication requests and cross indication request for multiple studies.• Served as lead for multiple Adhoc requests and served as a quality validator in several studies with critical timelines and consistently met critical deliverable targets.• Annotated case report forms (CRFs) according to the CDISC Implementation Guideline for migration to SDTM.• Maintained and created specification for Adhoc requests based on the client specific analysis algorithm.• Created SDTM specifications document based on CDISC Implementation Guideline• Followed standardized SDTM migration programming procedures to create quality Standard Data Tabulation Model (SDTM) compliant SAS datasets.• Created analysis datasets (e.g., ADAM) specifications based on Statistical Analysis Plan (SAP) or any study analysis algorithm.• Converted analysis datasets specifications into SAS code to generate datasets and Tables, Listings, and Figures outputs.• Programmed and validated SAS programs for Datasets, Tables, Listings, and Figures following the departmental QC procedures.• Supported and collaborated with Data Management teams with data cleaning by providing data listings and patient profile reports.• Reviewed Pinnacle 21 Validator reports and troubleshoot findings with team. • Experience in extracting data from clinical databases, importing third party vendor data in various source formats and validating against the specifications using SAS.• Followed appropriate corporate SOPs, responsible for clearly documenting all paperwork and producing high quality deliverables.

Los Gatos, Ca, Us

-Responsible for review of clinical study documents including DTP (Data transfer plan), mapping specifications and form specifications related to Questionnaire data (QS).-Performed data extraction, data cleansing, data transformation and manipulation on both test and production data as per the mapping specifications-Extracted, manipulated, summarized, analyzed and presented data using SAS procedures -Meticulously analyzed and validated data sets and SAS outputs using PROC FORMATS ,PROC COMPARE, PROC CONTENTS, and PROC FREQ. -Understand and implement CDISC and other regulatory standards.-Making sure all programming activities and processes are conducted according to standard operating procedures and good programming practice-Actively involved in writing SAS code for transitioning studies into SAS.

Cambridge, Ma, Us

-Experience in various data management skills like merging, handling missing values, reading raw data files, creating data structures, handling programming errors, accessing and managing data, appending, concatenating, and interleaving of SAS datasets.-Experience in annotation of CRF.-Experience in preparation of SAS datasets, Tables, Listings, Reports, Output Delivery System (ODS) and Summaries according to requirements and specification.-Experience in importing and exporting files using LIBNAME, PROC IMPORT, PROC SQL, PROC EXPORT.-Experience in design, writing and debugging the macro routines and applying macro variables in a SAS program.-Generated reports using SAS report generating procedures like PROC PRINT, PROC REPORT, PROC TABULATE, PROC FREQ, PROC MEANS, PROC TRANSPOSE and PROC SQL.-Created TLF’s (Demographic and Baseline characteristics, Adverse Event table, Lab Shift table)-Generated graphs by employing SAS procedures like PROC SGPLOT.-Exposure to clinical trial data such as demographic data (DM), Adverse Events (AE), Disposition (DS), Laboratory data (LB) and Vital Signs (VS).-Good understanding of CDISC processes such as SDTM and ADaM-Knowledge on electronic submission data package including define.xml for FDA submissions

Piscataway, New Jersey, Us

-Good operational knowledge on Learning Management System (LMS) – e.g. Moodle, Sakai and NEO LMS.LMS administrator for Moodle and Sakai coordinating course management, course archiving, portal functions, user roles and user privileges-Administer programs and ensure users are enrolled in proper programs or lessons-Edit, standardize, organize or make changes and to upload the materials in learning portal-Reviewing results and assisting in reporting results to upper management-Assist users in basic requests like resetting passwords or grade correction-Track bug resolution and feature requests on learning management system-Perform other various system and user administrator tasks on learning management system-System administrator for content Management Systems (CMS) Joomla and WordPress

Bangalore, Karnataka, In

-Work with research scientists in the analytical research groups to understand their lab processes, data flow and data analysis needs.-Define requirements based on the application-Empower CDS-Support Chromatography Data Acquisition Systems. This includes installing, maintaining, and supporting the data acquisition software and hardware on desktops as well as the server-Collaborate with software development teams to add missing features to existing applications-Involved in writing Test cases.-Executing complex test setup and performing test cases-Reported bugs and verified and fixed defects. -Conducted Funtional, System, Regression & Integration testing including multi-lingual testing using pattern matching.-Documented software defects using bug tracking system and reported defects involving program functionality, output, online screen and content to software developers via PVCS tracker.-Provided domain support for Lifesciences domain.

Bangalore, Karnataka, In

-Responsible for chemical and physical analysis of API molecules- Intermediates, Raw materials and Finished product to ensure that the results comply with pharmacopeia specifications and In house -specification using HPLC, GC, UV, SOR, IR and Auto titrator.-Preparing and issuing Certificate of Analysis for finished product as per specification and customer requirements.-Responsible for standardization of volumetric solutions.-Responsible for standardization of API Molecules- Laboratory and Working Standards-Involved in Stability Analysis of API molecules.-Responsible for the training (on the job) to new trainees. Presentations and proper training were given for newly joined trainees with proper GLP practices-Responsible for calibration of Instruments

Bangalore, Karnataka, In

Quantitative determination of oxytocin receptor antagonist atosiban in rat plasma using liquid chromatography-tandem mass spectrometry(LC-MS/MS)

Bachelor'S Degree, Biotechnology

Master'S Degree, Biotechnology