JC Rawal

acz6b8@r.postjobfree.com

*** ******** *****

Cary, NC 27513

919-***-**** US Citizen

Summary of Experience:

Quality and detail oriented programmer/engineer with multi-disciplinary experience and education in clinical programming, biostatistics, bioinformatics, data analytics, computer engineering with pharmaceutical/CRO/healthcare experience (Phase I – IV trials in Neonatology, Psychiatry, Infections and Gastroenterology areas), mapping, programming, debugging, validating CDISC SDTM/ADaM datasets, annotating and book-marking eCRF, updating SDTM specifications, generating TLF from shells, define.xml, providing justifications to Pinnacle21 validation report of define.xml, creating SDRG(study-data-reviewer’s-guide) for timely CRT package delivery.

Interdisciplinary experience/education in biostatistics, bioinformatics, data analytics, clinical programming (CDISC/SDTM, TFL), and computer systems.

Software, firmware, hardware design/development/debugging/testing/validations of IBM servers

Languages: SAS, C/C++/e, VHDL/Verilog, X86 Assembly, HTML, Perl, Java, FORTRAN, BASIC

Development Tools: SAS, SAS/EG, SAS Enterprise Miner, MS SQL Server/DB2/Teradata, Cypress PSoC programmer, SYNOPSYS, MS Office Suite tools.

Operating Systems: Windows, Linux, AIX/UNIX, OS/2, DOS, VM, MVS

RECENT PROFESSIONAL EXPERIENCE/EDUCATION:

Clinical SAS programmer Sept 2016 – Apr 2017

PAREXEL International (Through Boston, MA based CRO)

Rapastinel (GLYX-13) antidepressant, Double-blind, Placebo Controlled, Randomized Withdrawal Phase-2 study.

Creating/debugging/validating Unix SAS/SAS EG programs for CSR TLFs and RTFs for blinded and unblinded data from SAP, aCRF, and Shells of GLYX-13 study.

Help in cleaning DM source dataset by reporting errors at data entry (EDC) - level

Creating in-text tables for medical writers, Generating Patient Profiles, updating ADaM datasets

Safety and clinical pharmacology of Stanate (Stannsoporfin) in infants at-risk for exchange transfusion, comprised of seven separate open-label and double-blinded, multi-center, single and multi-dose, randomized studies.. Stanate treated babies from less than 48 hrs age to less than 14 days of age were followed up to 9 years of age for physical, neurologic, neurodevelopmental, biochemical, metabolic and hematologic profiles.

Creating/debugging/validating Unix SAS/SAS EG programs for SDTM production and qc programs with batch runs, checking logscans and compare reports.

Documenting raw data issues and programming data issues in trackers; Committing programs/TFL in version control tool SmartSVN; PMED documentation.

Data Transfer Mapping Specs (DTMS), annotating and book-marking CRFs, generating SDTM specs with value-level metadata for creating define.xml and validating define with OpenCDisc Validator and Pinnacle21 validator, providing justifications to validation report, and creating Study-Data-Reviewers-Guide (SDRG) for CRT package delivery.

Informatics Analyst Sept 2015 – Sept 2016

Blue Cross Blue Shield of NC, Durham, NC (Through TSG, NC)

State Health Plan Analytics and Reporting. Insurance Payment Recovery, Vendors pre-pay, post-pay, invoice reports. Provider medical/insurance claims analytics.

(Tools: MS Office, PowerMHS, Business Object, SAS/Teradata,SQL)

Clinical SAS Programmer May 2015-July 2015

Prosoft Clinical, Raleigh, NC (Through GES, PA)

SAS programming activities supporting Phase I - III clinical trials

Create tables/listings for safety/efficacy reports for various requests, Dry Runs, etc.

Create and validate various SDTM domains, such as Adverse Events, ECG, LAB, Vital Signs, PK Parameters, PK Concentrations, etc. for Phase-I randomized cross-over study

Perform validation of SAS programs, creating analysis datasets and TLFs.

Help in cleaning DM source dataset by reporting errors at data entry (EDC) - level

Help in set up SAS environment and study related documents

Update SDTM specifications based on CDISC Implementation guide 3.2.

Create utility macros for use in single or multiple studies.

Statistical/SAS Analyst+Clinical Programmer Dec 2013-Jan 2015

Salix Pharmaceuticals, Raleigh, NC (Through DataMasters, NC)

SAS programming for mapping aCRF (Oracle/Inform) to SDTM CDISC Domains

Create and validate SDTM datasets for multi-center randomized Phase-IV trial

Create TFL for various types of requests including business data

Develop SAS programs for displaying descriptive and inferential statistics using various

SAS procedures like UNIVARIATE, TRANSPOSE, FREQ, SUMMARY, etc.

Created utility macros for use in clinical studies or business projects

Help in set up SAS environment and study related documents

Analyzing business statistical data to improve marketing/sales efficiencies using Excel

(vlookups/pivots), SQL (Symphony/Veeva databases) and SAS Platforms. (SAS/Base,

SAS/STAT, macros, correlations, regressions, PROC SQL, SAS Enterprise Miner)

Business projects like Speaker-program/Web-cast profitability, HCPs indexing for insurance health plans, factors affecting written prescriptions

Working with Rx/Claims data, Physician data, Sampling/Detailing/Deciling data.

Programmer/Engineer Apr 2005 – Jan 2009

CTG/IBM, Durham, NC Nov 2009 – Aug 2013

Design and development support of Data Storage Area Network (RAID SAS) controller/cluster components

Validation of IBM PowerPC processors using Windows/Linux platforms. Power Sequencing embedded PSoC design in C. Board and System BringUp activities including Python scripts and Database complex SQL queries.

IBM BladeCenter development, Test/debug/develop Embedded C programming application for fan controller using Cypress PSoC designer,

Malaysia/China travels for customer/manufacture support and problem resolution.

SAS/Macro Language Essentials class at SAS Campus, Cary, NC July, 2013

Macro variables, delimiting macro references, macro functions, macro parameters,

creating macro variables in DATA step and in SQL, SYMPUTX, Conditional and

iterative macros, parameter validation, indirect referencing.

Comprehensive SAS SQL Essentials Class at SAS Campus, Cary, NC August, 2012

Non-correlated and correlated subqueries; Complex SQL joins/intersects/unions;

Creating tables & Views, Dictionary tables; SQL and Macros; Benchmarking; Indexes,

Managing tables.

Rigorous week-long SAS Clinical Data Integration Class at SAS, Cary, NC April, 2011

Designing jobs with SAS Data Integration Studio (aka ETL); Case Study Description;

Domain loading jobs; Registering Study Source Tables; Defining Target Domain

Metadata

Programmers activities: Creating jobs to load DM/XP/SUPPDM/QS domains; CDISC-

SDTM Compliance Checks for DM/QS and Externally Supplied AE Domains;

Generating standard and customized CRT-DDS Define.xml files

Clinical Study and Clinical Data Standards Administration activities; Importing

Standard Domains, Domain Columns, and Compliance Check Metadata; Analyzing

Domain usage and promotion of custom domains; Creating customized compliance

checks; importing controlled terminology; Creating: Terminology Packages, Default

Contents and New Clinical Study.

Adjunct staff May, 2002 – July, 2014

Technical/Community Colleges, Raleigh, NC

Teaching SAS Programming/GRE Math

SAS programmer/Data Analyst, Contractor Jan 2009 – Jan 2010

US Environmental Protection Agency, Epidemiology & Biomarker Branch, Chapel Hill, NC

(Human Studies Division)

CITI certified; Dynamic SAS macro programming/datasteps/proc usage; SQL; Global macro variables with SYMPUT/SYSFUNC/NRSTR/etc;

Data analysis for environmental and asthma studies; Working with epidemiologists and statisticians on different studies at EBB / NHEERL / EPA.

For air pollution health effects studies (EPA, NCSU): Developed a SAS application program that provides daily mortality counts aggregated for specific underlying causes (e.g. cardiovascular or respiratory) as per ICD-10 coding for specific Metropolitan Statistical Areas. These daily mortality counts were to be correlated to fine particulate matter (PM2.5) measurements from STN monitors of different MSAs to study air pollution effects.

Summarizing results with tables, figures, charts and graphs with PROC TABULATE, REPORT, GPLOT, etc

Other studies: (Detroit Children’s Health Study/DCHS, and Mechanistic Indicators of Childhood Asthma/MICA)

Studying for Ph.D. program Biostatistics/Bioinformatics Jan 2003 – Jan 2010

NC State Univ, Raleigh, NC

Statistical Methods for Biological Experiments: SAS 9.1 for Statistical Analysis.

Conducting appropriate tests of hypotheses (one-sample, two-sample, paired-sample, Analysis of Variance, Chi-square, Contingency Tables, McNemar’s, Wilcoxon signed rank, Rank Sum, Mann-Whitney) Confidence limits for means, variances; designing effective experiments, SAS programming and SAS output analysis. Completed extra SAS programming classes at NCSU.

ANOVA, Simple linear regression, Multiple/Polynomial/Factorial regressions and GLM models. Main and Simple effects, Contrasts, Blocking, Fixed and Random effect models, Split plots. SAS programming and SAS output analysis of above models using Base/SAS, SAS/STAT, SAS/GRAPH, macros, etc.

Hands on Data Mining training. Applied Analytics with SAS Enterprise Miner 5. pattern discovery, Cluster and Market Basket analysis (support, confidence, lift, association & sequence analysis, un/supervised learning, cubic clustering criterion, linkages, principal components, logistic regression, over/under fitting,log worth, logit, Gini index) Decision/classification Trees, Neural Networks, model assessment, Banking Segmentation and Credit Risk case studies, Sensitivity & Specificity, ROC curves

Fundamentals of Clinical Trials: Statistical concepts, Epidemiology (cross-sectional, prospective & case-control studies; relative risks; odds-ratio); Clinical Trials: Phase I: dose-finding/toxicity/Maximum Tolerated Dose, Adaptive/dose-escalation design; PK parameters. Phase II: Gehan’s/Simon’s two-stage designs. Phase III: design issues and choice of primary end-point; Randomized Clinical Trials/permuted block/stratified design, Adaptive randomization (Pocock & Simon minimization; Efron-biased coin/Urn model design), sample size and desired power; multiple treatment comparisons (Bonferroni correction, Hochberg’s approach), binary and continuous responses; Equivalence/Non-inferiority Trials; non-compliance and Intent-to-Treat, Power and Sample Size calculations, Survival analysis (hazard rate, Censoring and life-table methods/Kaplan-Meier/ product-limit estimator), Group sequential/Interim analysis, Information-based design, Pocock & O’Brien-Fleming boundaries/power-sample size in terms of information, inflation factor; data censoring and stopping trials early). Familiarity with ICH/GCP/FDA.

BioInformatics Algorithms: Restriction mapping and DNA motif finding algorithms; Genome re-arrangements;

Dynamic and divide-conquer algorithms; global/block sequence alignments; Space-time improvements; Combinatorial pattern matching; Gene expression analysis; Clustering and trees.

Homology; Pairwise and multiple sequence alignments, dynamic programming, Needleman-Wunsch global and Smith-Waterman local alignment; BLAST(PSSM/PSI/PHI/FASTA; Scoring schemes: BLOSUM/PAM; Hidden Markov Modeling: Forward/Viterbi algorithm/PSA/MSA with HMM; ClustalW/ProbCons/MUSCLE/T-Coffee; phylogenetics.

Baysian statistics: Rejection and Importance sampling/Markov Chain Monte Carlo/Gibbs sampling/Metropolis-Hastings; RNA secondary structure prediction: Zuker and Nussinov RNA folding algorithm;

Protein structure and Annotation; Branch-and-bound technique for protein threading; protein databases: Swissprot/PDB/CATH; SCOP; Assessment of CASP7 predictions for template-based modeling targets review;

Cell Divisions, Mendelian/Population/Molecular Genetics, Chromosomal/DNA Mutations, Replication (priming, Pol III holoenzyme, termination), RecBCD pathway for homologous recombination, mechanism of transposition, Transcription (roles of three RNA polymerases, sigma/alpha subunit structures and roles, promoters, core polymerase in elongation, Rho-dependent and independent termination, operons, phage lambda lysis/lysogeny infection, enhancers/silencers, transcription factors, DNA binding motifs/activators, chromatin structure and gene activity, posttranscriptional RNA processing, spliceosomes, RNA interference) Translation (initiation complex/factors, ribosomes, elongation, tRNA, termination, proofreading and editing) – Proteins, Gene Structures, Genetic Regulation, Pedigree linkage and association analysis; Bacterial Recombination, Biotechnology (Restriction Endonuclease, Cloning Vectors, PCR, DNA Sequencing, Gene mapping, Blots, VNTR, cDNA, etc) methods.

Structural and Functional Genomics: mapping, sequencing, genome annotations, genotyping, transcriptome,

Proteomics, expression and genome profiling, association mapping, SNPs, microarray data analysis, protein microarrays

BioTech Lab: Extraction and Manipulation of recombinant DNA, basic molecular biology and protein chemistry, theories behind lab techniques and overview of cloning strategies. Gel electrophoresis.

Lab works: for subcloning, preparation of competent cells, transformations, screening recombinant

DNA by colony hybridization and antibody, PCR, SDS-PAGE, affinity purification, protein quantitation, and western blots.

Past Professional Experience:

Zaiq Technologies - Consultant, Raleigh, NC

Verification of Ericsson Cell Phone ASIC chip and Agere Terabyte Switch chip functions.

IBM Corporation, Boca Raton, FL and RTP, NC

Design/development HW/SW engineer: Various Chip-, Board- and System-level design, development projects; Simulation/test/debug and manufacture support of IBM systems using, hardware, firmware and software tools; Timing, Functional and Signal Quality verification in the lab. Product Release and System Assurance support. Problem Resolution of IBM PCs.

Invention Disclosures in IBM Technical Disclosures Bulletins

Education:

Completed most course work for BioInformatics/BioStatistics Ph.D. program at NC State University, NC.

EE(MSEE)/Computer Engineering, Ohio State University, Columbus, Ohio.

M.Sc. Physics, Electronics (Solid State/Electronics/Communications); India.

Other on-the-job training Courses: Good Clinical Practice (ICH-E6), Introduction to Unblinding and Randomization, PMED Central File Maintenance and Quality Control (QC), Statistical Programming Deliverables, Specification Development for Statistical Programming and Biostatistics, Reporting and Management of Serious Breaches of Good Clinical Practice, Data Management SOPs for Statistical Programming & Biostatistics, PMED and Central file training for Biostatistics and Statistical Programming, Sponsor Audit Awareness Training, Fraud and Non-Compliance in Clinical Research

VHDL/Verilog, Verification Tools, Unix/AIX, C ++, C-Shell, Perl, Java, Data Base Mgmt Systems, SQL, Access, Comp Graphics and other Computer Science classes taken and programs written; OS/2 Problem Resolution (Kernel Debugger), REXX; HTML, etc.

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