Job Title:
Biostatistician
Company: Trigent Software - Professional Services
Location: Kannur, Kerala
Created: 2025-08-21
Job Type: Full Time
Job Description:
Job Title: Senior BiostatisticianLocation: Bangalore/RemoteJob Type: Full TimeJob Summary:As a Senior Biostatistician, you will lead the statistical design, analysis, and reporting of clinical trials and Real World Data (RWD) studies. You will collaborate cross-functionally with clinical, regulatory, data management, and programming teams, serving as a strategic partner throughout the study lifecycleKey Responsibilities: Oversight and co-ordination of statistical activities in clinical studies and regulatorysubmissions. Provide statistical expertise in the design, planning, evaluation anddocumentation of clinical trials and RWD studies. Tasks include but are not limited to: · Clinical and RWD study design discussions· Input to study protocols and sample size calculations· Develop Statistical Analysis Plan (SAP)· Prepare data standard and reporting specifications (ADAM and TLFs)· Conduct statistical programming (using SAS and R)· Perform statistical analyses and exploratory work e.g. modelling and simulation· Documentation of the results in statistical and clinical reports· Discuss results interpretation with customers· Support internal process development· Mentoring and supporting colleagues within the biostatistics and programming team· Project management and co-ordination of statistical deliveries for studies Qualifications:Master of Science in Statistics or MathematicsMinimum 5 years of experience of statistical design and analysis of clinical and/or RWD studiesKnowledge about statistical software (e.g., SAS, R)Ability to manage multiple projects and work both independently and collaboratively