Senior Biostatistician

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 Danahers 15 operating companies our work saves livesand were all united by a shared commitment to innovate for tangible impact.

Youll thrive in a culture of belonging where you and your unique viewpoint matter. And by harnessing Danahers system of continuous improvement you help turn ideas into impact innovating at the speed of life.

At Leica Biosystems were not just shaping the future of cancer diagnostics were 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 youre not just taking a job; youre becoming part of a passionate team that knows every moment matters when it comes to cancer. Youll 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 youll be inspired each day to stretch grow and make an impact.

Learn about the Danaher Business System which makes everything possible.

The Senior 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 infectious disease hematology 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 and will beremote.

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 other teams 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:

• Bachelors Degree in Statistics or Biostatistics with 8 years of experience OR MS in Statistics or Biostatistics with6 to 8 years of experience OR PhD in Statistics or Biostatistics with4 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

• 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

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.

Leica Biosystemsa Danaher operating company offers a broad array of comprehensive competitive benefit programs that add value to our lives. Whether its a health care program or paid time off our programs contribute to life beyond the job. Check out our benefits atDanaher Benefits Info.

Join our winning team today. Together well accelerate the real-life impact of tomorrows 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.

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Required Experience:

Senior IC

Employment Type : Full-Time
Experience: years
Vacancy: 1