Data Professional Experience

EXPERIENCE SUMMARY

ROLES

Clinical SAS Programmer

Data Scientist

Clinical Data Analyst

Clinical statistical programmer

SKILLS INVENTORY

Analysis

Reporting

Pharmacovigilance

SAS clinical trial programming

Statistics

Macros

CDISC

Regulatory affairs

ADAM

SDTMTABLES

Graphs

Figures

CRF

SOP

Informed consent

Clinical trial methodology

Datasets

Statistical Analysis

Perform Statistical Analysis

Predictive Modelling

Multivariate Linear Regression

Logistic Regression

Ridge Regression

Lasso Regression

Time Series Forecasting

Survival Analysis

Functional:

Pharma

Health care

Technical:

SAS: Base SAS, Advanced SAS,

SAS/SQL, SAS/macro, SAS/access, SAS/connect, SAS/ODS, SAS/EG, SAS/BI

R, Python, UNIX

Oracle, SQL Server, Sybase

10 years of relevant professional experience as a SAS Clinical Programmer relevant career experience in the pharmaceutical, health care and biotechnology industry, experience with small biotech companies and high paced work environment is a plus

Create analyses or validate the deliverables from CROs to support the request for information from regulatory agencies post NDA/MAA submissions

Generate and QC summary tables, data listings and graphs for in-house analyses of study data, ongoing assessment of clinical trial data or publications

Analyze and Support data queries from other functional groups (Clinical Development, Data Management, Medical Affairs, Clinical Operations, Regulatory, and Marketing)

Highly knowledgeable with CDISC guidelines and specifications for ADAM datasets

Excellent knowledge of SAS programming and associated areas and their application to the pharmaceutical industry, particularly as it applies to clinical trial data

Proficient with CDISC guidelines, i.e. SDTM and ADaM models and hands on experience implementing these models

Experience with medical or health research.

Experience with SAS graph, macros, PROC SQL, ODS, SAS/ACCESS and data extraction from large relational databases.

Comfortable in working with UNIX environment and UNIX scripts.

Proficient in preparing reports for clinical audiences.

Good knowledge of Teradata SQL.

Knowledge of quality improvement metrics

Experience with data management software Level-headed and calm able to work efficiently in high-stress situations and with imminent deadlines excellent communication skills both oral and written and ability to relate relevant information to appropriate personnel Organizational skills necessary for multitasking and keeping consistent and accurate records.

EDUCATION

PhD – Bio Chemistry from Gitam Institute of science & Technology.

PGDCR – Post Graduate Diploma in Clinical Research from NIMS.

Master of Science-MSc- Biochemistry- University of Madras, Chennai.

Master of Business Administration- MBA E-business from Annamalai University, Chidambaram.

Postgraduate Diploma in Computer Applications- PGDCA Computer Applications Geeni Computer Education, Hyderabad.

PROFESSIONAL EXPERIENCE

Amgen, Thousand Oaks, CA Oct 2016 - Present

Clinical SAS Programmer

A Randomized Double-blind Study to Evaluate the Safety and Efficacy of Denosumab Compared with Zoledronic Acid in Postmenopausal Women with Osteoporosis Previously Treated with Oral Bisphosphonates.

Responsibilities:

Read and understand the study protocol, statistical analysis plan and CRF.

Creation of ADaM dataset specification and ADaM dataset or non-standard dataset.

Design, develop and maintain programs that will produce and/or validate safety and efficacy tables, listing and figures.

Participate in establishing the programming scope for a deliverable with study statistician and study team and ensure high quality results and milestones are achieved efficiently.

Creation of macros and use existing macros to generate reports.

Responsible to ensure that all output within a project is accurate and has consistent appearance.

Work on multiple projects simultaneously and meet the timeline.

Responsible for developing and maintaining programming and validation specifications for TLGs as per requirements provided by the Biostatistician.

Create and maintain SAS programs to produce outputs to support the analysis and reporting of clinical trials.

Develop analysis datasets for trial level reporting and integrated safety and efficacy activities

Program and QC data listings, summaries and Graphs as defined in SAP. If required, validate the statistical models used for programming.

Develop re-usable utility macros in order to build a macro library to support programming tables, listing and graphs for phase 1-4 clinical trial reporting.

Collaborate with the project team to ensure the deliverables are completed on time with high quality.

Create submission-ready standard data presentations and data sets using standard coding and following standard industry processes including SDLC.

Maintain all project documentation as required by SOP and Processes.

Ensure compliance with company and industry quality standards, guidelines and procedures

Other duties as assigned

Merial Inc, Duluth, GA Aug 2013 – Sep 2016 Clinical SAS Programmer

Comparing Therapies to Treat Hyperkalemia (Elevated Potassium) in Feline Urethral Obstructions This trial is to compare two therapies used to treat hyperkalemia associated with feline urethral obstruction.

Electrolyte abnormalities can occur with feline patients due to the obstruction of urine flow. Potassium is readily excreted in the urine, but with a urethral obstruction, our feline patients develop elevated potassium levels, known as hyperkalemia. Hyperkalemia has a number of life-threatening effects such as arrhythmias and low heart rates with severity directly proportional to the degree of hyperkalemia. The goal of this project is to compare the efficacies of terbutaline and a combination of insulin & dextrose in treating cats for hyperkalemia.

Responsibilities:

Produce tables, listings and datasets to support the tabulation and analysis of clinical trials.

Work included accessing and assembling clinical data from a variety of sources, including data management systems and vendor data.

Converting data to SDTM or client specific structures, following project specifications

Creating derived datasets using ADaM or client specific specifications

Generating tables and listings.

Identifying inconsistencies or problems in the source data and reporting findings to the project lead.

Writing, documenting and performing quality control review of programs and command files.

Effectively utilizing SAS® and other software and tools as required by projects and process seeking introductory knowledge of CDISC Standards, SDTM and ADaM.

Data preparation, cleaning, manipulation, and visualization. Extract data from relational databases and perform complex data manipulations. Also conducted extensive data checks to ensure data quality.

Worked with team members to understand market and client specific needs for development of new consulting solutions or refinement of existing services.

Presented and communicated results of data mining efforts in a manner consistent with the target audience and business needs.

Document all SAS programs developed and write other documentation as needed. Identify and share best practices for key topics.

BIOGENE, INDIA Feb 2011- Jul 2013

SAS Programmer

A phase V post-license clinical trial of vaccines against the human papilloma virus (HPV).

Responsibilities:

Locally coordinate and take responsibility for trial level programming activities (analysis datasets, pooled datasets, listings, tables and figures) of individual Phase I-IV clinical trials to support program programmers and statistician in project level activities.

Be responsible for statistical tasks on assigned clinical trials e.g. RAP.

Maintain efficient interfaces with internal and external customers with support of ONC Biometrics management and the Program Programmer/Statistician.

Make certain that documents and specifications are consistent and comply with company standards by providing input into CRF and data structures tables, listings and figures for phase I-IV clinical trials and submission activities.

Program and deliver, according to specifications, analysis datasets, pooled datasets, listings, tables, and figures for phase I-IV clinical trials and for pooled analysis with high quality and within milestones.

In consultation with the statistician, develop specifications for analysis datasets, pooled datasets, and listings.

Maintain records for all assigned projects and archiving of trial / project analysis and associated documentation.

Provide input on process improvement initiatives and participate in non-clinical project activities with support from GH

Shantha Biotechnics, INDIA Oct 2007 – Jan 2011

Senior SAS Programmer/Analyst

Shantha Biotech's Shan-5, its 5-in-1 vaccine A single vaccine to protect infants against five diseases -- diphtheria, pertussis, Hep-B, tetanus, and a bacterium causing pneumonia and meningitis.

Responsibilities:

Clinical trial basics, statistical analysis in clinical trials

Development of SOPs - SAS requirements testing validation

CRF - Case Report Forms, SDTM specification, ADaM specification

TLGs Table Shells - tables, lists and graphs.

SAP - statistical analysis plan, template.

CDISC 101 mapping lab -use control terminology to create format catalog, proc format.

Create raw clinical datasets, lab data, DM, ADSL, and AE/ADAE.

Clinical data analysis and reporting

Trials data with hands-on projects on clinical trials data sets.

Knowledge of schedule Y, ICH-GCP guidelines, CIOMS, HIPAA, CTRI, informed consent and patient information sheet.

Clinical research methodology: Clinical trial study design, conduct, monitoring and close-out

Experience Evaluate data through SAS systems and interpret into relevant statistics Design new SAS software and strategies that can be used to increase efficiency.

Prepare presentations showcasing information found as well as how it relates to the future of the company Participate in annual efficiency and safety testing and help validate findings.

Gathered information from all aspects of the company and translate into SAS programs for analysis Participated in clinical trials and formed reports of findings to be presented to superiors used information from SAS programs to develop graphs and diagrams relatable to the average employee.

SAS GLOBAL CERTIFICATION

Specialization University/Institute Year

SAS-Advanced programming SAS Inc. U.S.A 2013

Business intelligence content development SAS Inc. U.S.A 2013

Base programming SAS Inc. U.S.A 2013

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