Principal Biostatistician

5 days ago

Bengaluru, India George Clinical Full time

We are expanding We are hiring a Principal Biostatistician We have many new ground-breaking global clinical trial projects in various phases and therapeutic areas across the globe and want your ideas and expertise to help us build and grow.


Who are we?

  • A leading global clinical research organization founded in Asia-Pacific driven by scientific expertise and operational excellence.
  • 20+ years of experience, 500+people managing 39+ geographical locations throughout the Asia-Pacific region, USA, and Europe.
  • Full range of clinical trial services to biopharmaceutical, medical device, and diagnostic customers, for all trial phases, registration, and post-marketing trial.
  • We combine scientific leadership and global operational excellence, with strong experience in renal medicine, oncology, and cardiovascular and chronic diseases to improve the health of millions worldwide.


Why work with us?

  • We are a global team, making a social impact.
  • Competitive market salary and benefits
  • Flexible and agile working arrangements - onsite, hybrid, or WFH (dependent on location)
  • Strong and diverse Learning & Development opportunities including exposure to scientific leadership.
  • A focus on employee wellbeing including global employee engagement surveys, steps challenges, reward and recognition programs, team building activities, and other fun events


Key responsibilities:

  • Perform, plan co-ordinate, and implement the following for complex studies.
  • Participate as biostatistician on project(s) including but not limited to reviewing protocols, preparing analysis plans, randomization plan, and writing sections of joint clinical/statistical reports.
  • The programming, testing, and documentation of statistical programs for use in creating statistical tables, figures and listings.
  • Giving inputs to protocol writing for the stats section and sample size estimation and power calculations. o Programming SDTM datasets.
  • Programming analysis datasets (derived datasets including efficacy datasets) and transfer files for internal and external clients.
  • The programming quality control checks for the source data and report the data issues periodically Participating in DSMC/DSMB
  • Answering queries from regulatory authorities.
  • Ability to interpret project level requirements and develop programming specifications, as appropriate, for complex studies.
  • Provide advanced technical expertise in conjunction with internal and external clients, and independently bring project solutions to SP teams and Statistical Programming department, for complex studies.
  • Directly communicate with internal team including data management, project management, and client statisticians and client team members to ensure appropriate understanding of requirements and project timelines.
  • Use and promote the use of established standards, SOP and best practice.
  • Participate in project meetings; keep up-to-date on project issues;


Education and Expertise:

  • M.Sc. or Ph.D. in Biostatistics, Maths, or science-related field.
  • Minimum 6 years experience with statistical programming and/or 10 years in the Biostatistics or related work in the CRO environment.
  • Minimum 10 years experience as a biostatistician in the CRO/Pharma environment.
  • Technological proficiency in SAS
  • Ability and motivated to learn and develop
  • Good teamwork and willing to help other team members.
  • Technological proficiency including Microsoft Office packages.
  • Ability to see the big picture, yet still focus on detail and quality of work.
  • Ability to be flexible and adaptable in the face of changing organizational priorities and ambiguous environments.


This is an excellent opportunity to work with a growing and global CRO. We offer a competitive salary package, flexible working conditions, and strong growth and development opportunities. Please follow us on LinkedIn to learn more about your future with George Clinical.


We welcome confidential queries and are happy to have a call to discuss this and future opportunities at your convenience. Applications and enquiries for this role should be directed to . All applications will be treated confidentially.


We are reviewing applications as we receive them but please note that only short-listed applicants will be contacted.


Thank you for your interest in working with George Clinical. As a global business, we are committed to handling Personal Information in accordance with applicable privacy and data protection laws in the many countries in which we do business. Please see our Privacy Policy for further information.


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