Summary
Overview
Work History
Education
Skills
Languages
Websites
Therapeutic Area
Accomplishments
Timeline
Generic
GANESH RAJU

GANESH RAJU

Pondicherry

Summary

Biostatistician with over 7+ years of working experience as study lead statistician and expertise in developing & reviewing Statistical Analysis Plan (SAP), mock shells in accordance with study protocols. Having a good knowledge of various statistical methodologies and perform statistical review of TLFs. And knowledge of applicable clinical research regulatory requirements, i.e., Good Clinical Practice (GCP), International Conference on Harmonization (ICH) guidelines and FDA guidelines. Moreover ability to establish and maintain effective working relationships with co-workers, managers, and clients.

Overview

8
8
years of professional experience

Work History

BIOSTATISTICIAN-II

IQVIA RDS PVT LTD
Bangalore
04.2022 - Current
  • Perform Statistical Team Lead role for studies. Through this works closely with the project team lead and supervisor to deliver on time with high quality and within budget. Build and maintain the effective customer relationship. Also, runs meetings, documenting where
    necessary and following up on actions. Actively participates in internal project team meetings, provides timely progress updates.
  • Develop or performs quality control review (QC) of analysis plans, table shells, programming and table specifications; produce tables, listings and figures; perform data review and statistical analysis.
  • Plans and documents timelines, forecasts resource needs, suggests work may be out of scope.
  • Advise data management staff on critical data. May advise on validation checks.
  • Understand the Scope of Work, budget, and quote assumptions, estimate the work completed, and manage scope for studies.
  • Be a primary point of contact for customer/client.
  • Shares accountability (with resource managers) for the financial success of assigned studies. Accountable for controlling costs and maximizing revenue recognition. Responsible for sharing budget expectations with the team. Raises concerns to manager if new work or
    rework appears to be out of scope. Understands 'scope of work' and has an awareness of contract and budget assumptions.
  • Identifies risks to project delivery and/or quality and spends time to proactively avoid as well as proposes solutions to mitigate risks. Where possible, anticipate risks to minimize need for study level escalations.
  • Provide training, guidance and mentorship to junior level and new staff. Supports colleagues and provides motivation as needed.

BIOSTATISTICIAN-II

PAREXEL INTERNATIONAL
Bangalore
04.2018 - 04.2022
  • Coordinate the development of analysis plans, table shells, programming and ADaM specifications, the production of tables, listings and figures, data review and statistical analysis.
  • Write and review statistical sections of integrated reports.
  • Provide expert statistical input into and review of statistical deliverables (i.e. analysis plans, table shells, programming and table specifications, data review, tables, listings, figures and statistical sections for integrated reports) and data management deliverables (i.e. validation
    checks and critical data).
  • Understand the Scope of Work, budget, and quote assumptions, estimate the work completed, manage scope, and provide revenue and resource forecasts for single studies. May manage project budget and resource requirements.
  • Under the guidance of the Lead Statistician, prepare Study Statistical Analysis Plan.
  • Completion of Projects within the specified timeline with first time right quality.
  • Provide training and guidance to junior level and new staff.
  • Any other responsibilities as assigned by the management in liaison with the organization need.

SR.SME-STATISTICS

SPi GLOBAL
Pondicherry
04.2018 - 08.2018
  • Provided subject matter expertise and guidance to school and colleagues studies for the statistical problem solving.
  • Created statistical documentation including system diagrams, process flow charts, and white papers to make student easy understanding of statistical concept.
  • Identified needs of customers promptly and efficiently.
  • Assisted with customer requests and answered questions to improve satisfaction.
  • Managed time effectively to ensure tasks were completed on schedule and deadlines were met.

STATISTICIAN

STRIDES SHASUN
Bangalore
01.2016 - 01.2018
  • Prepared detailed reports summarizing the findings of medical research projects and Interpreted numerical information into meaningful insights that can be used by healthcare professionals.
  • Created graphs, charts, tables, diagrams, and other visual aids to generate statistical report.
  • Conducted literature reviews of published studies to develop methodology for clinical trials.
  • Documented procedures used in each project so that future researchers could replicate them.
  • Provided technical support and consultation on study design, data collection, and interpretation of results to formulation development scientist.
  • Trained staff members on proper techniques for entering data into electronic health records systems.

Education

Master of Science - Statistics

Pondicherry University
Pondicherry
05-2015

Bachelor of Science - Statistics

Indira Gandhi College of Arts And Science
Pondicherry
05-2013

Skills

Hard Skills:

  • SAS programming (Not Certified)
  • SPSS

Soft Skills:

  • Flexible to work
  • Ability to effectively manage multiple tasks and projects
  • Proactive communication and effective collaboration
  • Always adhere to quality deliverables within benchmark standard timelines

Languages

English
First Language
English
Upper Intermediate (B2)
B2
Tamil
Proficient (C2)
C2

Websites

Therapeutic Area

  • Oncology
  • Obesity's
  • Immunology

Accomplishments

  • IQVIA IMPACT PROGRAM - BRONZE AWARD, 2022

Timeline

BIOSTATISTICIAN-II

IQVIA RDS PVT LTD
04.2022 - Current

BIOSTATISTICIAN-II

PAREXEL INTERNATIONAL
04.2018 - 04.2022

SR.SME-STATISTICS

SPi GLOBAL
04.2018 - 08.2018

STATISTICIAN

STRIDES SHASUN
01.2016 - 01.2018

Master of Science - Statistics

Pondicherry University

Bachelor of Science - Statistics

Indira Gandhi College of Arts And Science

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GANESH RAJU