PROFESSIONAL SUMMARY:

*+ years’ experience as a biostatisticians in pharma industry

Excellent statistics background with particular strength in Randomization, Sample size calculation, descriptive statistics, nonparametric analysis, categorical data analysis, analysis of variance, covariance, linear, logistic, longitudinal data analysis (general linear models, generalized mixed models with random effects, GEE models), multivariate analysis, repeated measures, survival analysis (K-M estimation ; COX regression).

Working Knowledge of CDISC, SDTM/ADaM datasets for FDA and EMA submissions

Extensive experience in analyzing data using various statistical tools like SAS, SPSS, Tableau, R and NVivo.

Knowledge of Medical Dictionaries like Med DRA and WHO Drug

Have experience in Phase I, Phase II, Phase III and Phase IV studies

Proven ability to manage multiple assignments and handle changing priorities in a fast-paced environment.

Possess excellent communication skills, ability to perform exceeding expectations, demonstrated ability to quickly learn and teach new concepts and adaptability to change

Have excellent analytical, problem solving and interpersonal skills, with ability to interact with individuals at all levels of the organization and contributing to project success

SKILLS:

Statistical Tools: SPSS, SAS 9.4., SAS Enterprise Guide 7.1., Basic R, Tableau and NVIVO

SAS Procedures: TABULATE REPORT, PRINT, CONTENTS, MEANS, FREQ, UNIVARIATE, SUMMARY, FORMAT, CHART, GPOLT, SORT, TRANSPOSE, ANOVA, REGRESSION, AND COMPARE, Survival data analysis and GEE model.

Healthcare Data: Claims data, Electronic Health Records.

SAS Tools: SAS/BASE, SAS/MACRO, SAS/SQL, SAS/GRAPH, SAS/ODS

Productivity tools: MS office, MS word, power point, excel and Graphic designing.

Applications: nQUERY, Share point, Veeva Vaults (QMOD, RIM, CTMS/TRACK)

Codes: SNOMED, ICD, CPT/HCPCS

EDUCATION:

Master of Global Public Health (Major- Biostatistics) Jan’2015- Dec’2017

oGeorge Mason University, Fairfax, VA.

Bachelor of Naturopathic Medicine Aug’2009- Sep’2014

oRajiv Gandhi University of Health Sciences, India.

PROFESSIONAL EXPERIENCE:

Principal Biostatistician Jun’2022 - Current

Regeneron Pharmaceuticals, Inc., Tarrytown, NY

Therapeutic area: Immunology & Inflammation

With periodic supervision and guidance from senior departmental staff, provide support and leadership to a clinical study team on all relevant statistical matters. Act as liaison to study team, ensuring that the clinical study is conducted in a manner that supports planned statistical analysis.

With some supervision and guidance from senior departmental staff, design clinical study and help produce protocol or amendments. Perform relevant sample size calculations.

Develop statistical analysis plan (SAP).

Work with programming team to provide definitions, documentation, and review of derived variables needed to produce planned TFL.

Perform statistical analysis defined in SAP, prepare statistical methods and results sections for the clinical study report (CSR), and work with the study team to move the CSR through review and approval process. Provide statistical insight into interpretation and discussion of study results.

Produce / coordinate production of statistical summaries, analyses, annual reports, and related materials for submission to regulatory authorities or independent monitoring committees.

Provide assistance to project statistician or Therapeutic Area lead biostatistician in project activity and timeline tracking, resource planning, and preparation of scientific reports or position papers.

Using R calculated pooled SD for Statistical Review of Clinical Data (SRCD)

Lead SRCD and PD meetings

Review PD outputs and PD Plan

Public Health Statistician/ Biostatistics Manager Aug’2021 – April’2022

NJOY LLC, NY

Therapeutic area: Respiratory health, Tobacco products development (Public health impact studies)

Reporting to Director Biostatistics, acted as the Lead Statistician for clinical studies

Providing statistical expertise and input to product development programs including the design of clinical development plans, studies, and analyses requiring advanced statistical methodologies

Reviewing study protocols, developed the statistical sections of protocols and statistical analysis plans, including sample size calculation, the definitions of derived variables, the structure and content of analysis datasets, statistical analyses, and the design of templates for statistical tables, figures, and listings for clinical study reports

Providing statistical input into data management and programming deliverables including CRF design, analysis datasets (ADaM) to ensure that they fulfilled the trial objectives statistical analyses.

Working collaboratively with Statistical Programmers, Biostatisticians, Clinical Development, Clinical Operations, Clinical Data Managers, Safety, Regulatory, Project Management, and other staff and CROs to meet project deliverables and timelines.

Oversaw and contributed to the completion of all technical and operational statistical activities for multiple clinical trials

Lead Research Data Statistician IV Aug’ 2019- Oct’ 2020

UC Davis Medical Center, CA

Therapeutic area: Immunology & Inflammation

Wrote Statistical Analysis Plans (SAP)including analysis dataset and TLG specifications and provided input to CRFs.

Delivered statistical reports (tables, modeling, figures, and listings) of Safety, Efficacy, and Quality for regulatory (FDA) submission.

Assisted in Clinical Study Reports (CSR).

Delivered Safety Monitoring report, and summary tables/listings of adverse events (AEs /SAEs) in support of reporting to Data Monitoring Committee (DMC), regulatory authorities and ethics committees (ECs) or Institutional Review boards (IRBs) as appropriate.

Assisted in grants writing and manuscript writing

Proven performance in leading complex projects

Supervised staff, including setting performance goals and provided feedback

Provided statistical expertise and safety surveillance including the design of research/ statistical analysis plans and analyses requiring advance statistical methodologies

Biostatistician II May 2018 – July 2019

IA Foundation System, CA

Therapeutic area: Gastroenterology

Involved in experimental design, protocol review, protocol writing, developing SAP, and reporting.

Led statistical analysis, modeling and sas programming for various clinical trials/studies.

Created computer programs for randomization stratified by sites and baseline function status.

Generated monthly statistical reports, including summary of consents, randomized intervention, patient demography and characteristics, baseline assessments, and 24 months follow-up, as well as adverse events. Conducted statistical analysis for the clinical trial data.

Validated SAS applications developed by other SAS programmers.

Conducted database programming (SQL) post-processing: variable conversion specification, master dataset generation, CRF annotation, etc.

Mentored the lower-level programmers.

Research Statistician Dec 2015–Apr 2018

American College of Radiology, VA

Therapeutic area: Oncology, Medical device studies

Performed leading role in protocol development for study design, procedures, sample size determinations and propose statistical methodologies.

Led study team to review, proposed and developed the clinical study designs, procedures, and the statistical methodologies for study protocols.

Performed and reviewed statistical analysis details, interpreted analyses results, and wrote/reviewed the corresponding sections of the clinical study reports (CSR).

Authored the statistical analysis reports and oversee the generation of all statistical appendices.

Determined correlation between many variables using statistical software (SAS)

Prepared presentation and statistical analysis summaries

Conducted survey analysis on patient’s health care usage and trends using latest technology

Utilized comparative analysis to determine optimal models to address risk factors

Worked with clinical teams to resolve issues regarding the interpretation, evaluation, and reporting of clinical data.

Created a Macro facilities to work across various studies for reporting and listing of adverse Events.

Effectively and timely contacted Project Manager of the respective study about the various Data Issues and resolved the queries through meetings

Environmental Health Technician II May 2015 – Nov 2015

Fairfax County Health Department, VA

Therapeutic area: Infectious disease

Identification of disease carrying mosquitoes and ticks in Fairfax County

Conducted field activities associated with mosquito and tick-borne disease surveillance in Fairfax County

Conducted public outreach programs to educate members of the community on current outbreaks of disease (zika virus (mosquito-borne), Lyme disease (tick-borne)).

Monitored syndromic surveillance to identify clusters or outbreaks of disease and conducted epidemiological investigations on suspect cases.

Facilitated lab testing for patients meeting testing recommendations for outbreak investigation.

Compiled and presented data on rates of infectious disease.

Participated in and assisted in planning emergency preparedness exercises and trainings.

Worked closely with the Biostatisticians and assisted in Data analysis reports and Statistical Analysis Plan.

Graduate Research and Teaching Assistant Dec 2014- Dec 2017

George Mason University, VA

Therapeutic area: Epidemiological studies, Electronic Health Records

Conducted research to identify the perceived positive and negative effects on well-being of avid video gaming through the perspectives of avid gamers and their close observers (Human subjects).

Conducted surveys and collected data, using methods such as interviews, questionnaires and focus groups.

Implemented and managed data collection; data tracking and quality control system for research operation; data analysis; transcribed the audio recording of the participants.

Prepared technical reports, consent forms, summaries and protocols. Includes, worked directly with Institution Review Board (IRB).

Created SAS macros to consolidate and streamline the data.

Analyzed data using SAS procedures like PROC SQL, PROC FREQ, and PROC SUMMARY in order to analyze the positive and negative effects of avid video gamers on well-being.

Coded and reused SAS macros.

Skilled in merging two or more SAS datasets, preparing and managing data.

Created a report or listings to find the frequency counts of screen failure subjects from Demographic dataset using PROC FREQ, MEANS and PROC report as per the requirement.

Worked as a part of E-Submission team and contributed towards the Data Cleaning and Data validation of the analysis datasets.

Health & Safety Inspector I Dec 2014- Apr 2015

George Mason University, VA

Responsible for coordination activities for safety management team including preparing agendas, slide presentations and recording the minutes

Involved in Quality checking various safety activities including data entry

Support team members in training activities related to Drug safety and reporting of any unusual activities on campus

Educating students about infectious diseases and various communicable diseases

Educating students about alcohol use on campus in university.

Clinical Biostatistician & Intern Mar 2011- Nov 2014

HCG Cancer Center, Bangalore, India

Therapeutic area: Oncology

Responsible for data management and SAS programming for producing Summaries, Listings, Graphs for statistical analysis and reporting.

Participated in Statistical Analysis Plan (SAP) along with other Biostatisticians as a part of Data Management Plan.

Involved in clinical trials programming of data tables and listings for reporting on safety and efficacy.

Interacted with different departments like Clinical, and Data Management co-workers for collection and reporting of clinical trial results.

Validated analysis datasets and TLG’s for Phase I, II and III studies.

Involved in creating patient summaries to support the Clinical Document submission.

Medical Resident Sept 2012- Sept 2014

SDM Medical College, India

Took detailed case history of patients.

Measured patients’ vital signs

Prepared and administered medications as instructed by the physician.

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