Lead Biostatistician

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 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 Cepheid we are passionate about improving health care through fast accurate molecular diagnostic systems and tests. As a member of our team youll 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 worlds most complex health challenges. Together we bring MORE change to the world.
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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 addition to clinical trials the Lead 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:

• Masters or PhD in statistics public health or epidemiology with a minimum of 6 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

Cepheida 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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