Clinical Data Analyst Jobs

Experience/Education:

Typically requires a minimum of 5 years of related experience with a Bachelor’s degree; or 3 years and a Master’s degree, or a PhD without experience, or equivalent work experience.

Ph.D. or M.S. in life sciences preferred.

Responsibilities:

Work with scientists, medical leads, biostatisticians, and the clinical affairs team to plan, write, and edit clinical study protocols and CSRs for registrational studies.

Work efficiently and accurately, adhering to best practices and departmental standards for

terminology, content management, and reuse.

Release finished documentation to Document Control Management system, and maintain

organized records of all materials, drafts, and previous versions.

Quickly learn and apply new tools, processes, and standards as needed.

Be adaptable and forward-thinking in the face of technological or organizational change.

Propose improvements to authoring tools as needed.

Requirements:

Clinical protocol and CSR writing experience in the medical device/IVD industry.

Experience with regulatory approval of IVD/medical devices is preferred.

Knowledge and familiarity with genomic data generated by Illumina sequencing platforms.

Excellent team skills, written and oral communication skills.

Broad experience in study design and data analysis for IVD/medical devices and experience with industry publications is a plus.

Be a strong partner who intelligently gathers input from multiple stakeholders and deals

effectively with ambiguous or missing information.

The job requires strong organizational skills and excellent time and project management.

A sophisticated understanding of the principles and practices of medical writing, content

management, and reuse is essential.

Expert in Microsoft Office products, Adobe Acrobat, and web authoring tools.

Proficient in English, attentive to industry-leading standards, and equipped with excellent

grammatical and editorial skills.