Davita Inc.
Principal Biostatistician (Biomarker Analyst -EMEA and US BASED)
Davita Inc., New York, New York, us, 10261
Principal Biostatistician (Biomarker Analyst - EMEA and US BASED)
Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs, and commercial insights into outcomes to address modern market realities.
Our Clinical Development model centers on the customer and the patient. We are committed to simplifying and streamlining our work to make Syneos Health easier to work with and for.
Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you'll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to accelerate the delivery of therapies because we are passionate about changing lives.
Discover what our 29,000 employees across 110 countries already know:
WORK HERE MATTERS EVERYWHERE
Why Syneos Health
We develop our people through career development, support, training, peer recognition, and rewards.
We foster a Total Self culture where you can be authentic. We care for our people and value diversity of thoughts, backgrounds, and perspectives.
Job Responsibilities
Major tasks include:
Collaborating with other functions to plan, execute, and analyze biomarker aspects of clinical studies, including genomics and devices.
Developing the Biomarker Evaluation Plan ensuring consistency across projects.
Coordinating statistical activities for biomarker research and development.
Conducting advanced data analysis for genomics and biomarker statistics, including programming and complex algorithms.
Producing and ensuring the accuracy of the Biomarker Evaluation Report.
Working independently on routine and complex statistical tasks.
Developing standard processes for routine biomarker assessments.
Additional tasks may include mentoring, overseeing other biostatisticians, supporting all statistical tasks during project lifecycle, preparing SAPs, reviewing study documentation, and supporting regulatory interactions. The role may involve leading projects, managing timelines, supporting data safety monitoring, and ensuring regulatory compliance. Minimal travel may be required.
Qualifications
Strong knowledge of biomarker evaluation, especially in Oncology, ctDNA data, and biology.
Graduate degree in biostatistics or related field.
Extensive experience in clinical trials, leading multiple projects.
Proficiency in programming.
Excellent communication skills in English.
Get to know Syneos Health
Over the past 5 years, we have worked with 94% of FDA-approved drugs, 95% of EMA-authorized products, and conducted over 200 studies.
Learn more at
http://www.syneoshealth.com Additional Information Tasks and responsibilities are not exhaustive. The company may assign other duties as needed. Qualifications may be considered equivalent. This description does not create a contract. We are committed to compliance with applicable laws and regulations, including the ADA and EU directives.
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http://www.syneoshealth.com Additional Information Tasks and responsibilities are not exhaustive. The company may assign other duties as needed. Qualifications may be considered equivalent. This description does not create a contract. We are committed to compliance with applicable laws and regulations, including the ADA and EU directives.
#J-18808-Ljbffr