Mobile: 313-***-****

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Kidambi Shravya Deepika

Shr avya Deepi ka

PROFESSIONAL SUMMARY

Graduate Student at Wayne State University in Industrial Engineering with a focus on Healthcare with a GPA of 3.74

Certified SAS programmer- BASE SAS 9 certified.

Six Sigma Green Belt Certified.

Experience as working in Clinical data management involving clinical trials for Johnson & Johnson at Tata Consultancy Services.

Knowledge in clinical trials, clinical data flow and documents involved from various phases of clinical trials to the submission of data to regulatory authorities. TECHNICAL SKILLS

R programming, SAS, Microsoft Office, H lookup, V Lookup, pivot tables, Dashboards, SPSS, Minitab, QM software, Excel solver, R studio, Clustering analysis, t-test, F-test, ANOVA, Regression models, Healthcare Claims Data, ADaM and CDISC/SDTM, ICH, EMEA, EDC applications (e.g. Inform, RAVE), Familiarity with different querying/reporting tools, Tableau, TLFs,SAS Macros, SAS/ SQL, and SAS/STAT, Data Governance familiarity Principal Component Analysis, Factor Analysis, Linear, Non-Linear Regression, Time-Series, Cluster Analysis, longitudinal data analysis (e.g. LME, GEE), nonparametric methods, eCOA, ePRO, data mapping, SQL coding, ETL, Metadata and electronic report development, Data Quality Review Plan (DQRP), CTR, Analyses Data Sets (ADS), Clinical Trial Operations & CTMS process, ISS

& ISE.

Six Sigma - 5 S, Capability analysis, DMAIC, SIPOC, Lean, Kanban, Kaizen, Business process management involving CTQ, COQ, Various Distributions & plots,Measurement System Analysis, DOE, Control Charts, Lean operations, SWOT analysis,KPIV & KPOV, PDCA, Gantt chart, PERT, Gage R & R, Multi-vari Analysis,

RELEVANT EXPERIENCE

Pursuing Education

(Master’s Degree: Industrial Systems Engineering / Healthcare) 08/15 - Present

04/16 - Present

Dr. Michael Joseph Rybak (Eugene Applebaum School of Pharmacy, WSU) Currently working with Dr.Michael Joseph Rybak's Anti-Infective Research Laboratory (ARL) in the Department of Pharmacy Practice, Wayne state University. Current work involves filling and submission of IRB applications, ammendments, data collection from various hospitals and potentially involved in the analysis of the data for the outcomes research projects of Anti-infectives, Infectious diseases using statistical software’s like SAS and SPSS.

Dr. Roche Lab (Eugene Applebaum School of Pharmacy) 10/15 – 12/15

Worked in Dr. Roche lab (Eugene Applebaum School of Pharmacy), assisting the laboratory with data collection, cell counting and statistical analysis using SAS, SQL and SPSS at Wayne State University. Six sigma Graduation projects:

Using Six Sigma Approach to Improve Healthcare Workers Safety using Six Sigma tools and approach like 5S, Kanban, VSM.

Mobile: 313-***-****

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Kidambi Shravya Deepika

Improving the Rejection rate of oil seals at Koch-Glitsch using Six Sigma Approach.

Lean Tools implementation

Deterministic Optimization of Surya Agro Farm - using Excel Solver: Graduation project Objective of the project involved maximizing the profit by determining the optimum proportion of crops, and Minimizing the cost of transportation by determining benefits using Excel Solver by defining indicator variables, transportation, Transhipment found a feasible solution that can be incorporated to achieve the profits or Break Even.

Technical Environments: Excel, Excel Solver, QM for Windows, Minitab Tata Consultancy Services, Mumbai 10/14 – 07/15

SAS Programmer / BASE SAS Certified / Medical Coder While engaged at Johnson & Johnson – Janssen Pharmaceuticals

Analyzed and coordinated clinical data, data reports and generate summary reports as per FDA regulation, Ad hoc requests, Participate in conference calls and/or meetings with vendors.

Created SAS programs to address outliers and missing data, duplicate observations in the clinical studies.

Experience extracting and reporting on healthcare trends, claims, membership, and pharmacy.

Prepared comprehensive reports using SAS report generating procedures like PROC PRINT, PROC FREQ, PROC MEANS and PROC SQL, SAS/ SQL, ODS (RTF, PDF, EXCEL) INPUT and INFILE options, Import and Export, SAS / Macros.

Created listings and outputs using SAS, based on the information specified in the DVR, merging, reading raw data files, handling programming errors, accessing and managing data, appending, concatenating, Interleaving of SAS data sets, finding out the edit check errors.

Developed, validated and implemented SAS programs and produced derived datasets for analysis and generated and documented Tables /Graphs/Listings for media analysis.

Generated reports with conditional, looping statements and Functions using IF-ELSE, DOUNTIL, DO- WHILE, ARRAY, SELECT-WHEN, SUM, ROUND, SCAN, TRIM, PUT, INPUT, CALL SYMPUTX.

Knowledge in Data Governance involving availability, usability, integrity, and security of the data employed in an enterprise.

Experience in ADaM / CDISC / SDTM datasets.

Technical Environments: SAS,SQL,MS Excel, MS Access, Macros, SDTM, CDISC, Share drive, Share point

While engaged on Medical Coder Experience:

Utilized O*C (Oracle*Clinical) TMS applications in a timely manner or to meet (interim) database lock or any timelines specified.

Worked on MedDRA dictionary and WHO drug dictionary, MSSO MedDRA browser, UMC Browser in accordance to the Client specific SOPs.

Authenticated accuracy of Terms processed and maintained the safety compliance, also ensured quality standards and carried out RDC onsite coding activities and Discrepancy Management activities.

Coded Rapid terms (TAT – 24 hours) through RDC On-site, Assign Codes, using the appropriate dictionary, for terms which have failed to auto-encode. Environments: MS Excel, OC tool, UMC browser, MedDRA browser, Rave

Experience in writing regulatory submission documents (e.g. Clinical Evaluation Reports, Investigator Brochures, Protocols, Integrated Summaries, Clinical Expert Reports, Responses to Regulatory Questions, safety documents such as Risk Management Plans, and Developmental Safety Update Reports, etc.)

Knowledge on statistical / econometric / data mining techniques to assess, monitor and forecast different sources of risk.

Mobile: 313-***-****

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Kidambi Shravya Deepika

Clinical Trial Knowledge:

Animal trials and various Phases of clinical Trials

IND and NDA application Fillings

IRB submissions, Ethical committee addressing and members.

Clinical Research associate Responsibilities including Monitoring the conduct of clinical trials and compliance with established timelines, Maintaining the quality of the work and relationships, Ensuring compliance with the patient-consent process and procedures to apply in the event of serious adverse events, Verifying the receipt, handling, accounting, storage conditions adhering to protocol regulatory requirements, GCP, Selecting the sites and Assessing the trial site, drafting an intervention plan for avoidance of redundant errors. Data Management Skills:

EDC work flow process, Study Build, CRF Development Specifications, CRF Designing, Data Validation Plan Specifications, SAE and External Data Reconciliation, Data Transferable agreement

(DTA), Data management plan (DMP),

Design and validate clinical databases including designing or testing logic checks, Process clinical data including receipt, entry, verification, or filing of information.

Remote Data Capture System – Electronic Data Capture Tool, Post production change control document, Risk and Impact Analysis Plan, DVR Test steps and test script creation, UAT process, UAT plan and UAT Report Creation, Data Management Plan, Project Management Tracker Overview.

Slight overview of SDTM Annotations.

ICH GCP Guidelines, 21 CFR Part 11, research, definitions, phases of trial, Interpretation of Protocol, ARMS, Randomization, Blinding Parallel/Crossover Studies, Time and Event Schedule, Essential Documents (Trial Master Files), E2A Guidelines, Reconciliation of third party data like LABS, IVRS, ECG.

While Pursuing Education (Doctor of Pharmacy) 08/10 - 07/14 Mahavir Hospital 11/12 – 06/13

Project

Role of High Dose Statins (Lipid Lowering Drugs) in Acute Coronary Syndrome at MAHAVIR Hospital (A.C Guards, Masab Tank) Under the esteemed guidance of Dr. Yerra Shiva Kumar

(Consultant cardiologist- Mahavir) – record based observational follow up study

Clinical profile of dilated cardiomyopathy (at MAHAVIR HOSPITAL) – record based Observational follow up study.

Hypothesis, Statistical analysis was obtained using SAS & SPSS (8 months) Krishna Institute of Medical Sciences Hospital, India 07/13 – 07/14 Internship

Final year (Internship) of Pharm D (2013-2014) – During the internship I have been posted to different departments like Cardiology, General Medicine, Pediatrics, Gynecology and obstetrics, Oncology, Pulmonology, Psychiatry where we assessed the cases and identify ADR’S Drug Interactions, prescription analysis including patient counselling and drug queries.

Analysis of patient records, count for prevalence of disease, Epidemiology, assessment of risk factors for diseases, Pharmacotherapy, drug disposition, linking lab reports to disease information, preparing reports were done using SAS. Mobile: 313-***-****

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Kidambi Shravya Deepika

Krishna Institute of Medical Sciences 10/09 – 10/12 Weekly Hospital Rounds

Ward round participation with physicians and case study, monitored adverse drug events, prescription interactions and reports, patient counseling. Answered drug queries of physicians and nurses, Review of patient records, found out the dosage, Medication errors and assessed the errors. Skills and Abilities

Excellent written, verbal and communication skills, quick learner and ability to work independently and under optimal supervision with excellent organization, planning and problem solving abilities.

Excellent negotiation and analytical, interpersonal skills, work effectively and efficiently in a matrix environment ensuring the implementation of project plans as assigned.

Experience demonstrating leadership ability and ability to work on a multi-disciplinary project team. R programming Skills

Read the raw data into R environment, wrote the data in CSV, Excel, Word Formats.

Performed a t-test to compare the control and treated groups finding p-value, FDR p-value, t-score, log Fold change.

Volcano plot, Responsible for histogram comparing groups Box Plots, Statistical analysis involving hypothesis testing, ANOVA, T test, Regression models, F test.

Created a matrix, conditional statements on matrix and vectors, as conversions Wilcoxan test and Euclidean Distance.

Responsible for pathway analysis using tools like WebGestalt,ErmineJ,etc., clustering, principal component analysis, data sorting, ordering, if then else statements, looping, Normalization, Significance finding

Involved in statistical computing and inference, data manipulation, calculation and graphical display, user-defined recursive functions and input and output facilities. Project Management skills: Integration, Cost, Time, Process, Human Resources, Procurement and Risk Management, Change control, Project Stakeholder management, Managing Conflicts and Trade off analysis, Cost – minimization, cost- benefit, and cost – effectiveness, and cost utility. CERTIFICATIONS & TRAINING

Six Sigma Green Belt Certified

Certified SAS Programmer- BASE SAS 9 Certified

Diploma in Clinical Research, Clinical Data Management EDUCATION

Master’s Degree: Industrial Systems Engineering / Healthcare; Wayne State University, Detroit, MI – In Progress with a GPA of 3.74.

Doctor of Pharmacy; Bharat Institute of Technology, Ibrahimpatnam, Hyderabad, India, Dec 2008 – July 2014, GPA of 4 / 4 .

ACHIEVEMENTS

Poster presentation & Intercollegiate quiz in International conference held at Anurag Group of Institutions (Lalitha School of Pharmacy) in association with the Royal Society of Chemistry

(London), Deccan section Hyderabad and secured first in quiz.

Poster presentation at KIMS-MAHAVIR “Evaluation of chronic hepatotoxicity after long-term treatment with Nevirapine in HIV patients”.

Participated in medical camp at Mangalpally village - organized from our college. Participated in interschool sports and drawing & art competitions and won many prizes.

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