Principal Biostatistican
This position is posted by Jobgether on behalf of a partner company. We are currently looking for a Principal Biostatistician in India.
This senior-level role sits at the heart of complex clinical research programs, driving the statistical strategy behind high-impact studies such as NDA submissions and multi-protocol trials. You will play a key leadership role in shaping study design, analysis planning, and regulatory-quality outputs across global projects. Working closely with cross-functional clinical, data, and scientific teams, you will ensure statistical rigor from protocol development through final reporting. The environment is highly collaborative, research-driven, and focused on delivering life-saving therapies to patients worldwide. You will also contribute to mentoring junior statisticians and strengthening methodological excellence across the organization. This is a role for someone who thrives at the intersection of science, strategy, and real-world clinical impact.
Accountabilities:
In this role, you will lead statistical strategy and execution across complex clinical studies, ensuring high-quality, regulatory-ready outputs and strong methodological rigor throughout the study lifecycle. You will coordinate cross-functional activities and provide statistical oversight for large, multi-site programs.
- Lead statistical input for complex studies, including NDA submissions and multi-protocol programs, ensuring scientific and regulatory compliance
- Develop and review Statistical Analysis Plans (SAPs), protocol statistical sections, and analysis deliverables for consistency and accuracy
- Oversee and validate statistical analyses, including quality checks of outputs and review of tables, figures, and listings (TFLs)
- Support project planning activities, including timelines, milestones, resource allocation, and study execution tracking
- Contribute to DMC activities, including charter development, meetings, and statistical support under senior guidance
- Perform advanced statistical modeling, sample size calculations, and randomization plan development
- Participate in bid defenses, audits, and client-facing scientific discussions for complex studies
- Mentor junior statisticians, review their work, and promote best practices across teams
Requirements
This role requires deep expertise in biostatistics and clinical trial methodology, with strong hands-on programming and leadership experience in regulated research environments. You should be confident working independently on complex studies while guiding others and communicating technical concepts clearly to diverse stakeholders.
- Bachelor's degree required; Master's or higher in Biostatistics or related field preferred
- 8+ years of experience in biostatistics or a combination of education and equivalent experience
- Strong proficiency in SAS or equivalent statistical programming tools for clinical data analysis
- Solid understanding of clinical trial processes, regulatory expectations, and statistical methodologies
- Experience developing SAPs, conducting analyses, and contributing to clinical study reports (CSRs)
- Strong knowledge of advanced statistical methods (e.g., survival analysis, regression models, categorical data analysis)
- Proven ability to communicate complex statistical concepts to both technical and non-technical audiences
- Experience mentoring or guiding junior team members in a scientific or clinical research setting
- Strong attention to detail, organizational skills, and ability to manage multiple priorities in parallel
Benefits
- Competitive compensation aligned with experience and industry benchmarks
- Flexible work arrangements, including remote or hybrid options depending on project needs
- Opportunity to work on global, high-impact clinical research programs
- Exposure to NDA-level submissions and complex, innovative study designs
- Professional development through mentoring, training, and scientific collaboration
- Participation in conferences, seminars, and external scientific engagements
- Supportive, research-driven environment focused on innovation and teamwork
- Travel opportunities for client meetings, audits, and training sessions (as required).
