Lead Biostatistician

Radiometer; Bengaluru; On-site; INR 1,800,000 - 3,200,000; Full time

Job summary

Cepheid, a Danaher operating company, seeks a Lead Biostatistician to advance statistical excellence in clinical trials, regulatory submissions and data integrity. The role focuses on planning, analysis, and mentorship within a fast-paced biostatistics team in Bengaluru, India.

Ideal candidates hold a Master’s or PhD in statistics or related field, with 6+ years of experience, SAS/JMP proficiency, and strong coding in R or Python.

Qualifications

• Master's or PhD in statistics, public health, or epidemiology with a minimum of 6 years of related industry experience.
• Proficient in SAS programming with certifications; knowledge of JMP/Minitab/NCSS for analysis and quality checks.
• Experience in DOE, regression, contingency tables, logistic regression, multivariate analysis, and ANOVA; programming in R and/or Python.

Responsibilities

• Support clinical trials by developing statistical analysis plans, overseeing statistical programming and authoring final reports.
• Develop SAPs and calculate sample sizes for Alpha/Beta trials, CE/IVD trials and generate final analyses for regulatory submissions.
• Administer and maintain SAS, SAS JMP, and Minitab licenses.
• Provide statistical support to R&D teams and mentor junior biostatistics teammates.

Skills

DOE

Regression

Logistic regression

Multivariate analysis

ANOVA

SAS programming

R

Python

Statistical software

Education

Master's or PhD in statistics, public health, or epidemiology

Tools

SAS

SAS JMP

Minitab

NCSS

Job description

Role Overview

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.

Lead Biostatistician Responsibilities

• Support clinical trials by developing statistical analysis plans, overseeing statistical programming and authoring the final statistical analysis reports.
• 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.

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 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.

Location

Bengaluru, India (on-site role)

Essential Qualifications and Requirements

• Master's 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.
• 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

Benefits

• 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. For more information, visit www.danaher.com. Danaher is a leading global life sciences, biotechnology, and diagnostics innovator, helping to solve many of the world’s most important health challenges, ultimately improving quality of life for billions of people today, while setting the foundation for a healthier, more sustainable tomorrow. The Danaher ecosystem is made up of more than 15 businesses united by a shared commitment to innovate for tangible impact. Please read our Applicant Data Privacy Notice carefully here.