Senior Biostatistician I / II
Company
ICON plc – Global Healthcare Intelligence and Clinical Research Organization
Job Details
Job Title: Senior Biostatistician I / II
Job Requisition ID: JR151271
Employment Type: Full-Time
Work Mode: Office or Home (Hybrid/Remote)
Locations:
Bangalore, India
Chennai, India
Trivandrum, India
Posted: 9 Days Ago
About ICON
ICON is a global healthcare intelligence and clinical research organization dedicated to accelerating the development of new medicines and treatments for patients worldwide. The company fosters a culture built on integrity, collaboration, agility, and inclusion.
Position Summary
ICON is seeking an experienced Senior Biostatistician to support clinical development programs through statistical leadership, study design, data analysis, regulatory support, and client engagement. The role involves leading statistical activities across clinical studies and mentoring junior statisticians.
Key Responsibilities
Statistical Leadership
Serve as the lead biostatistician for individual studies, study programs, and regulatory submissions.
Lead statistical activities supporting client and regulatory agency interactions.
Review and approve:
Statistical methods sections of study protocols
Statistical Analysis Plans (SAPs)
Statistical contributions to clinical study reports
Statistical Programming & Analysis
Perform statistical programming using SAS and/or R.
Conduct inferential statistical analyses for clinical research studies.
Ensure the quality and accuracy of statistical deliverables.
Client & Regulatory Support
Prepare and review research proposals and budgets.
Provide statistical consulting to clients.
Support regulatory submissions, including handling regulatory agency requests.
Participate in bid defense meetings and client presentations.
Team Development & Process Improvement
Mentor and support junior statisticians.
Lead or contribute to initiatives aimed at improving internal processes and developing statistical guidance.
Required Qualifications
Education
Master's Degree or Ph.D. in:
Biostatistics
Statistics
Or a related quantitative field
Experience
Minimum 6 years of biostatistical experience in:
Clinical Research Organizations (CROs)
Pharmaceutical companies
Biotechnology companies
Experience leading Phase II and Phase III clinical studies.
Experience managing:
Client relationships
Project timelines
Resource allocation
Experience in a CRO environment is preferred.
Regulatory Experience
Experience supporting regulatory submissions such as:
NDA (New Drug Application) submissions
Regulatory agency interactions and responses
Required Skills & Competencies
Advanced knowledge of clinical trial statistics and methodology.
Strong expertise in SAS and/or R programming.
Ability to plan, supervise, implement, and monitor statistical processes across multiple studies.
Excellent written and verbal communication skills.
Demonstrated leadership and mentoring capabilities.
Strong organizational and time management skills with the ability to prioritize competing responsibilities.
Compensation & Benefits
ICON offers a comprehensive rewards package that may include:
Competitive base salary
Performance-based incentives
Medical, dental, and vision coverage (where applicable)
Retirement and pension plans
Life insurance and disability coverage
Employee assistance programs
Health and wellbeing resources
Learning and development opportunities
Structured career progression pathways
Benefits may vary by role and location.
Employment Eligibility
Employment is contingent upon possessing the legal right to work in the country where the position is based.
Diversity, Inclusion & Accessibility
ICON is an Equal Opportunity Employer committed to creating an inclusive and accessible workplace where all employees feel valued and supported.
Applicants requiring reasonable accommodations during the recruitment process are encouraged to notify the company during the application process.
Internal Applicants
Current ICON employees should apply through the internal employee application portal.
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