Biostatistician

Morrisville, NC

Full-Time, Permanent

Major Responsibilities

:Plan, coordinate, and conduct statistical activities related to assigned projects, including study design, statistical analysis, interpretation of results, and preparation of reports

.Ensure compliance with regulatory requirements and industry standards, including Good Statistical Practice (GSP)

.Collaborate closely with scientists, engineers, clinicians, and external partners to integrate statistical considerations into all stages of the product development lifecycle

.Stay abreast of advances in statistical methodology and contribute to the development and implementation of novel statistical approaches to address challenges in diagnostic research and development

.Prepare clear and concise documentation of study protocols, analysis plans, and statistical reports

.Deliver release criteria, verification data and data for customer facing documentation

.Present at internal and external meetings as required

.
Required Qualification

s:Master's degree in Biostatistics, Statistics, or a related fie

ld2+ years relevant experienc

e.Proven experience in biostatistical analysis within a biomedical research/life science research setti

ngProficiency in open-source statistical software packages such as R or Python for data analysis and visualizatio

n.Excellent communication skills with the ability to effectively communicate complex statistical concepts to non-statistical audience

s.Detail-oriented with a commitment to accuracy and data integrit

y.Ability to work collaboratively in a fast-paced, multidisciplinary team environmen

t.
Preferred Qualificatio

ns:Ph.D. in Biostatistics, Statistics, or a related fi

eldExperience with analysis of fluorescence-based ass

aysFamiliarity with regulatory requirements for medical device development (e.g., FDA regulation