KARNADITYA RANA

*** ******* **** **. ac43xp@r.postjobfree.com

Piscataway, NJ 08854 516-***-****

PROFESSIONAL SUMMARY

Experienced and certified SAS Clinical Statistical Programming professional with experience in all four phases of clinical trials in pharmaceutical companies & CRO environment

General computing as relates to clinical drug development Knowledge of the drug development process, clinical trial methodology, statistics and familiarity with global regulatory requirements

Worked on creating and validating clinical study related documents like SDTM domains, ADaM specifications and mock-shell of TLGs

SAS ETL developer with expertise in design and development of Extract, Transform and Load data

Substantial experience in integrating studies for Integrated Summary of Safety (ISS) and Integrated Summary of Efficacy (ISE)

Worked extensively on creating and validating CDISC SDTM and ADaM datasets for various domains across safety, efficacy and subject-level datasets

Worked on various electronic submission level activities like reviewing define.xml/pdf, reviewer’s guide, aCRF etc.

Developed utility macros to make more efficient work like set up reporting environments, perform repetitive tasks, clean-up environment etc.

Worked on various therapeutic areas like Oncology, Virology, Respiratory etc.

Programmed derivation of responses as per RECIST criteria to derive standard oncology endpoints such as best overall response, objective response rate (ORR).

Created various plots like Kaplan Meier Curve (Survival plot) for Progression Free Survival, Waterfall plot, Scattered Plot etc. using SAS/GRAPH and PROC GPLOT using annotation facility

Thorough knowledge and experience in SAS BASE, MACRO, SQL, ODS, GRAPH and STAT.

Strong experience in generating customized reports for statistical results using SAS procedures MIXED, GLM, LIFETEST, PHREG, LOGISTIC, UNIVARIATE etc.

Good working knowledge and understanding of various standards, criteria and dictionaries used in clinical studies like CDISC, RECIST, NCI CTCAE, MedDRA and WHO DD etc.

Current knowledge of GCP/ICH Guidelines and Regulations

Healthcare reference data and associated metadata and its use in building trustworthy datasets: data standards and formats, ontologies, terminologies (e.g., ICD, CPT etc.)

Knowledge of International medical terminologies (e.g., ATC etc.)

RDBMS use & configuration

Experience in working on data cleaning, edits check, generating exploratory reports etc.

Very good understanding with Clinical Terminologies and Regulatory Guidelines.

PROFESSIONAL EXPERIENCE

Clinical SAS Data Analyst- Rang Technologies Inc., NJ

September 2017 – April 2018

Generated and validated SAS datasets using Clinical Data Interchange Standards Consortium (CDISC) standards.

Created and validated SDTM and ADaM datasets according to CDISC guidelines to generate Tables, Listings and Figures as per specifications and in compliance with FDA, EMEA and other such agencies.

Performed quality checks (validation) for datasets, tables, listings & figures.

Thorough knowledge and experience with SAS BASE, SAS/SQL, SAS/MACROS, ODS, GRAPHs.

Created various plots like Kaplan Meier Curve (Survival plot) for Progression Free Survival, Waterfall plot, Scattered Plot etc. using SAS/GRAPH and PROC GPLOT using annotation facility.

Developed CRF/eCRF designs with team.

Worked on creating trial design model (TDM) with statistician for various studies

Created SAS macros for routine procedures like frequency table, date imputation, clean-up, proc compare etc.

Developed various edit check programs to find data discrepancies in datasets to maintain issue and resolve logs

Worked with data manager on finding as well as reporting data issues

Experienced with ISS/ISE data sets; creation and validation.

Assisted in the creation and documentation of new departmental procedures and protocols for programmers.

Clinical Research Data Programmer- Hahnemann University Hospital, Philadelphia, PA

September 2016 – June 2017

Supported assignments on different safety domains such as Laboratory data, Adverse Events, Concomitant Medications etc.

Extensively involved in creating and validating Tables, Listings and Graphs (TLFs)

Validator role for clinical study report (CSR)

Worked with the biostatistics and clinical teams to support ad-hoc requests

Routinely worked on ADaM analysis datasets from SDTM data like ADSL, ADAE, ADLB, ADRS etc.

Worked on creating trial design model (TDM) with statistician for various studies

Created SAS macros for routine procedures like frequency table, date imputation, clean-up, proc compare etc.

Developed various edit check programs to find data discrepancies in datasets to maintain issue and resolve logs

Worked with data manager on finding as well as reporting data issues

Public Health Research Analyst- Philadelphia Department of Public Health, Philadelphia, PA

June 2016 – December 2016

Part of patient satisfaction survey planning and conduction team.

Planning, editing and conducting of surveys in PDPH’s Ambulatory Health Service centers.

Created and managed the survey database for generating annual reports for commissioner’s office using Survey Monkey for creating database and SAS/STATA for analysis and report preparation.

Knowledge of Extract, Transform and Load (ETL) frameworks

Presented and explained information suggesting improvements in policies

Reports created were used for decision making regarding health policy modification for the subsequent financial year.

Clinical Data Analyst- SNG Hospital & Research Center, India

January 2013 - July 2015

Experience working on various studies from Phase II, III and IV clinical trials to provide statistical programming support for SDTM, ADaM, TLFs

Involved in preparation of interim analysis for time-sensitive activities

Combined data from various studies to produce pooled datasets for reporting of ISS/ISE

Involved in data cutoff process development for DMCs

Identified gaps in statistical analysis plan (SAP) and specifications for the mock shells

Reviewed Protocol, Statistical Analysis Plan (SAP), and shells for tables, listings and figures for projects

Provided inputs to project statistician and programming team on the development and implementation of the statistical analysis plan (SAP)

Created SAS macros to generate more descriptive Kaplan-Meier plots for the needs of clinical and statistical reviewers

Delivered complex summary tables based on algorithm provided by internal medical team for safety and efficacy analysis

Worked in creating and validating various efficacy datasets like ADEF, ADTTE, ADRS etc. and safety datasets like ADAE, ADLB, ADVS etc.

Worked on multiple regulatory submissions like ISS/ISE and define.xml.

Management Trainee- Choithram Hospital and Research Centre, Indore, MP, India

April 2012 - July 2012

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Learned Electronic Medical Record management using Hospital software record management system.

Trained in healthcare reference data and associated metadata and its use in building trustworthy datasets: data standards and formats, ontologies, terminologies (e.g., ICD, CPT etc.)

Knowledge of International medical terminologies (e.g., ATC etc.)

RDBMS use & configuration

Coordinated and volunteered in several blood donation camps organized by the hospital during training period.

Medical Data Manager- Rana’s Medical/Dental Clinic, India

March 2008 - March 2013

Acquired data from Electronic Medical/Dental records and maintaining databases

Performed statistical analysis after data mining for business trend predictions and forecasting

Interpreted trends or patterns in data sets and reported to the operations team

Cleaned data by reviewing computer reports, printouts, performance indicators and edit checks to locate and correct coding issues

Managed Electronic Medical/Dental Records (EMR) and created relevant datasets by data mining.

Used statistical packages for analyzing datasets (Excel, STATA, SAS etc.) to perform the statistical operations while data analysis

Managed inventory records and produced inventory utilization reports

EDUCATION

MPH in Environmental & Occupational Epidemiology, Drexel University, Philadelphia, PA

MBA in Hospital & Healthcare Management, DAV University, Indore, India;

BDS (Bachelor of Dental Surgery), Jiwaji University, Gwalior, India;

TECHNICAL SKILLS

Operating Systems

WINDOWS, UNIX

SAS Skills

SAS/BASE (V8, V9), SAS/STAT, SAS/MACRO, SAS/SQL, SAS/ACCESS, SAS/GRAPH, SAS/ODS.

Databases

My SQL, MS ACCESS

Other Skills

MS-Office suite, ArcGIS, R-studio, Oracle Clinical

SKILLS

SAS Base Certified (Certificate Serial Number: BP074594v9)

Working knowledge of Epidemiology (EOH), biostatistics, clinical study designs, healthcare management, data analysis and visualization methods, healthcare informatics.

Knowledge of CDISC protocols for FDA-regulated clinical trials and CFR 21 part 11

Working knowledge of Software Development Life Cycle (SDLC), ICH/GCP and FDA guidelines for clinical trial data management

Languages: Hindi (Native), Marathi (Elementary), Punjabi (Elementary), Gujrati (Elementary).

CERTIFICATIONS

SAS Base Certified Programmer, SAS® Global Certification, USA 2017

Biomedical Responsible Conduct of Research 2017

GCP for Clinical Trials with Investigational Drugs and Biologics (ICH Focus) 2017

GCP for Clinical Trials with Investigational Drugs and Medical Devices (U.S. FDA Focus) 2017

Health Information Privacy and Security - Medical, Biomedical, Nursing, Public Health and Psychology 2017

Design and Interpretation of Clinical Trials by Johns Hopkins University 2018

PERSONAL SKILLS

●Excellent communication, presentation and interpersonal skills, as well as acute listening skills

●Detail oriented, ability to understand complex problems and develop solutions

●Able to identify issues and consistently collaborate to solve problems in a timely manner

●Ability to handle multiple priorities under tight timelines

●Team player and self-motivated

●Excellent analytical and problem-solving capabilities, result-oriented and able to deliver results

Contact this candidate