Lead Biostatistician, Global Quality, Regulatory, Clinical Affairs

Location: Bengaluru

Bring more to life.

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

At Cepheid, 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 Cepheid, we are passionate about improving health care through fast, accurate, molecular diagnostic systems and tests. As a member of our team, you'll get to make an immediate, measurable impact on a global scale, within an environment that fosters career growth and development. Our mission drives us to develop groundbreaking solutions for the world's most complex health challenges. Together, we bring MORE change to the world.

Learn about the Danaher Business System which makes everything possible.

The  Lead   Biostatistician  will support clinical trials by developing statistical analysis plans, overseeing statistical programming and authoring the final statistical analysis reports. This position will be the point of contact for FDA and other regulatory agency questions pertaining to study design and analysis. In addition to clinical trials, the Biostatistician will also assist in any supporting analysis such as precision and reproducibility studies, interfering substances, limit of detection (LOD), exclusivity and inclusivity studies, method comparisons, accuracy, and linearity studies carried out by the new product development or clinical affairs teams.

This position reports to the Clinical Affairs Manager, Global QRC On-market Sustainment and will be an on-site role in Bengaluru, India.

In This Role, You Will Have The Opportunity To

Develop Statistical Analysis Plans and calculate sample sizes for Alpha and Beta clinical trials, and CE/IVD trials and well as generate final statistical analysis report for regulatory submissions.
Administer and maintain statistical software licenses, including SAS, SAS JMP, and Minitab site licenses.
Provide statistical support to R&D teams and mentor junior biostatistics teammates in statistical software.

The Essential Requirements Of The Job Include

Master's or PhD in statistics, public health, or epidemiology with a minimum of 3 years of related industry experience
In addition to maintaining Basic and Advanced SAS certifications, candidate must have demonstrated proficiency in statistical methodologies including DOE, regression, contingency tables, logistic regression, multivariate analysis, and ANOVA, as well as programming experience in R and/or Python
Ability to independently program in SAS, including macro development, with documented use in more than 3 major submissions or projects and proficiency in statistical software systems such as JMP, Minitab, or NCSS for statistical analysis and quality checks.

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

Certified Advanced programmer for SAS
Consider the business needs in different trial design scenarios and educate the cross functions on how to improve our chance of success for the future clinical trials

Cepheid, a Danaher operating company, offers a broad array of comprehensive, competitive benefit programs that add value to our lives. Whether it's a health care program or paid time off, our programs contribute to life beyond the job. Check out our benefits at Danaher Benefits Info.

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.

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