Lead Biostatistician

IQVIA India; Maharashtra; On-site; INR 1,500,000 - 2,200,000; Full time

Job summary

IQVIA India is seeking a skilled Trial / Study Lead Biostatistician to manage statistical activities for Phase 2 & 3 clinical studies. The ideal candidate will possess strong SAS programming skills and at least 5 years of relevant experience in the pharmaceutical industry.

The role includes developing Statistical Analysis Plans (SAPs), collaborating with clinical scientists, and mentoring junior team members. Strong knowledge of regulatory guidelines and proactive communication are essential for success in this position.

Qualifications

• Minimum 5 years of experience as a Master's level Statistician or 4 years post-doctoral experience in pharmaceuticals.
• End-to-end knowledge of Phase 2 & 3 clinical studies.
• Strong understanding of US FDA and ICH guidelines.

Responsibilities

• Serve as Trial / Study Lead Biostatistician for Phase 2 & 3 clinical studies.
• Collaborate with clinical scientists on protocol design.
• Write and finalize Statistical Analysis Plans (SAPs).
• Design Case Report Forms (CRFs) for data capture.
• Mentor junior biostatisticians.

Skills

SAS programming

Clinical trial statistics

Proactive communication skills

Statistical Analysis Plan (SAP) writing

R Programming knowledge

Education

Master's or PhD Degree in Statistics

Job description

We are looking for a skilled and proactive Trial / Study Lead Biostatistician to join our growing team. The ideal candidate will bring deep expertise in clinical trial statistics, regulatory guidelines, and SAS programming — with the ability to work independently and lead end-to-end statistical activities for Phase 2 & 3 studies.

EDUCATION REQUIREMENTS

• Master's or PhD Degree in Statistics from a reputed university

EXPERIENCE REQUIREMENTS

• Minimum 5 years of experience as a Master's level Statistician, OR Minimum 4 years of post-doctoral experience (PhD) as a Statistician in the pharmaceutical or medical devices industry
• End-to-end knowledge of Phase 2 & 3 clinical studies
• Ability to work independently with proactive communication skills

TECHNICAL SKILLS

Must Have:

• Strong knowledge of SAS Base and multiple statistical procedures in SAS
• In-depth knowledge of ICH E6, ICH E3, ICH E8, ICH E9 guidelines
• Strong understanding of US FDA requirements for clinical trials
• Expert in Statistical Analysis Plan (SAP) writing and reviewing

Good to Have:

• R Programming knowledge
• Sound knowledge of theoretical and applied statistics

KEY RESPONSIBILITIES

• Serve as Trial / Study Lead Biostatistician for Phase 2 & 3 clinical studies
• Collaborate with clinical scientists on protocol design and author the statistical section of study protocols
• Write, review, and finalize Statistical Analysis Plans (SAPs)
• Design Case Report Forms (CRFs) to ensure all required data points are captured
• Review and approve analysis dataset specifications
• Produce analyses as specified in the SAP and perform ad-hoc analyses as requested
• Develop statistical programs to perform analyses and prepare data displays
• Coach and mentor junior biostatisticians
• Stay current with new developments in statistics, drug development, and regulatory guidance through literature review and professional development
• Work independently and proactively communicate across clinical and regulatory teams
• Other responsibilities as assigned by Senior Management

DESIRABLE ATTRIBUTES

• Strong communication and presentation skills
• Excellent team collaboration and cross-functional working ability
• Proactive, self-driven with strong ownership mindset
• Ability to mentor and guide junior team members