Lead Biostatistician

Leica Biosystems; Bengaluru; On-site; INR 2,000,000 - 3,500,000; Full time

Job summary

Leica Biosystems in Bengaluru, India seeks a Lead Biostatistician to provide end-to-end statistical support for clinical study design, analysis, and reporting for regulatory submissions of IVD diagnostics.

This role requires leadership in statistical methods, SOP reviews, mentoring junior statisticians, and collaboration with global teams to ensure compliance with FDA, CE, and CLSI guidelines; travel is limited.

Qualifications

• Bachelor’s or higher in Statistics/Biostatistics with extensive experience in regulated clinical studies.
• Experience leading statistical teams in analysis and reporting for IVD/medical devices.
• Knowledge of FDA/CE/WHO guidelines and regulatory submission processes.

Responsibilities

• Provide end-to-end statistical analysis support for IVD product life cycle development.
• Lead statistical input in clinical study designs including sample size estimates.
• Author statistical sections for protocols, SAPs, TSRs submitted to FDA/CE.
• Review SOPs, provide statistical training, and support audits of clinical data.
• Offer expert biostatistics input for reproducibility, LOD, accuracy and method comparisons.

Skills

Statistical leadership

FDA/CE guidelines knowledge

SAS

R

Python

Excel

Data interpretation

Education

Bachelor’s Degree in Statistics or Biostatistics

MS in Statistics or Biostatistics

PhD in Statistics or Biostatistics

Tools

SAS

Excel

Minitab

Python

R

Job description

Bring more to life.Are you ready to accelerate your potential and make a real difference within life sciences, diagnostics and biotechnology?

Bring more to life.Are you ready to accelerate your potential and make a real difference within life sciences, diagnostics and biotechnology? At Leica Biosystems, one of Danaher’s 15+ operating companies, our work saves lives—and we’re all united by a shared commitment to innovate for tangible impact. You’ll thrive in a culture of belonging where you and your unique viewpoint matter. And by harnessing Danaher’s system of continuous improvement, you help turn ideas into impact – innovating at the speed of life. At Leica Biosystems, we’re not just shaping the future of cancer diagnostics — we’re transforming lives. Our mission of “Advancing Cancer Diagnostics, Improving Lives” is the driving force behind everything we do. As a global leader with the most comprehensive portfolio spanning from biopsy to diagnosis, we empower clinicians with innovative, reliable solutions so they can give patients timely, accurate answers when they need them most. When you join Leica Biosystems, you’re not just taking a job; you’re becoming part of a passionate team that knows every moment matters when it comes to cancer. You’ll help develop diagnostic solutions that turn anxiety into answers, and aid the acceleration of next-generation, life-changing therapies. Surrounded by a diverse and collaborative global community, you’ll be inspired each day to stretch, grow, and make an impact. Learn about the Danaher Business System which makes everything possible.

Lead Biostatistician is responsible for providing statistical support for clinical study design, analysis, and reporting for registration/pre-market approval (CE-IVD and US-IVD) of qualitative and quantitative IVD molecular assays for blood biomarkers, hematology, infectious disease, and oncology applications across Danaher Diagnostics Op Cos. This position will be point of contact for regulatory questions pertaining to analysis. This position reports to the Senior Director, Biostatistics and is part of the global Bioinformatics team within Danaher Clinical Center of Excellence located in Bengaluru, India.

In This Role, You Will Have The Opportunity To

• Provide end-to-end statistical analysis support for IVD product life cycle development through creation and verification of multiplex biomarker signatures in infectious disease, blood diagnostics, and oncology to regulatory submission. This can involve the application of various statistical methodologies (general linear modeling, survival analysis, multivariate classification tools, etc.).
• Provide statistical input in clinical study designs including sample size estimates using OC and power curves while ensuring the team understands statistical risks of the study design and sampling plan used
• Author statistical section for clinical protocols, statistical analysis plans, statistical analysis reports, and clinical study reports submitted to FDA or other regulatory agencies.
• Review and update standard operating procedures for relevant functions, provide statistical training/education programs to junior statisticians as needed and support audits of clinical data.
• Provide expert biostatistics input for analytical studies such as reproducibility and precision studies, interfering substances, limit of detection (LOD), exclusivity and inclusivity studies, method comparisons, accuracy, and linearity study

The Essential Requirements Of The Job Include

• Bachelor’s Degree in Statistics or Biostatistics with 10+ years of experience OR MS in Statistics or Biostatistics with 8 to 10 years of experience OR PhD in Statistics or Biostatistics with 6+ years of experience
• Work experience as a lead statistician in analysis and reporting of IVD, medical devices, and imaging clinical studies in a regulated environment possibly as statistical team lead
• Knowledge of FDA, CE-IVDR, WHO and other diagnostics industry guidelines. The successful candidate will need to stay current on statistical standards (e.g. CLSI, etc.) and trends in the IVD industry as well as FDA and other regulatory agency guidelines.
• Relevant knowledge and usage of SAS, Excel, Minitab, Python or R with excellent oral and written communication skills
• Ability to convert business, scientific, and engineering concepts into clear mathematical/ statistical concepts and the ability to express them in ways understandable to non-statisticians and to mentor junior statisticians

Travel, Motor Vehicle Record & Physical/Environment Requirements

• Traveling less than 5%
• No physical demands

It would be a plus if you also possess previous experience in:

• IVD regulatory submissions and regulatory interactions with FDA CDRH and CE

Join our winning team today. Together, we’ll accelerate the real-life impact of tomorrow’s science and technology. We partner with customers across the globe to help them solve their most complex challenges, architecting solutions that bring the power of science to life.

For more information, visit www.danaher.com.