Senior Quality/Regulatory Biostatistician
iRhythm TechnologiesSalary not specified
Full Time
Senior (5 to 8 years), Expert & Leadership (9+ years)
Not SpecifiedCompensation
Junior (1 to 2 years), Mid-level (3 to 4 years)Experience Level
Full TimeJob Type
UnknownVisa
Biostatistics, HealthcareIndustries
Requirements
Candidates should possess at least 2 years of experience in statistics or biostatistics, preferably within the medical or clinical research field, and demonstrate experience with statistical programming tools such as STATA or R. Knowledge of regulatory guidelines and CDISC standards is preferred.
Responsibilities
The Biostatistician will assist in developing statistical methods and analysis plans for clinical trials, perform statistical programming tasks for clinical trial conduct and reporting, collaborate with cross-functional teams including Clinical Operations and Data Management, and communicate complex statistical results to stakeholders, ensuring adherence to regulatory guidelines and CDISC standards.
Skills
STATA
R
Statistical Methods
Clinical Trials
CDISC Standards
Regulatory Guidelines
Data Analysis
Lindus Health
Accelerates clinical trials for life sciences
About Lindus Health
Lindus Health focuses on speeding up clinical trials to help patients access new treatments more quickly. The company operates differently from traditional contract research organizations (CROs) by using a fixed-price model for studies and milestone-based payments, which aligns their incentives with those of their clients. Lindus Health combines a skilled clinical operations team with a specialized software platform and access to a vast database of 30 million Electronic Health Records. They handle all aspects of clinical studies, including designing the study, recruiting patients, capturing clinical data, monitoring progress, and managing projects. With their approach, Lindus Health has successfully assisted over 90 sponsors in conducting clinical trials across the US, UK, and Europe, completing them up to three times faster than conventional CROs and often delivering results ahead of schedule.
London, United KingdomHeadquarters
2021Year Founded
$23MTotal Funding
SERIES_ACompany Stage
Biotechnology, HealthcareIndustries
51-200Employees
Benefits
Health Insurance
Unlimited Paid Time Off
Flexible Work Hours
Mental Health Support
Enhanced Parental Leave
Professional Development Budget
Cycle to work scheme
Stock Options
Regular team events
A new laptop as your main workstation
Risks
AI-driven diagnostics could challenge Lindus Health's market position in clinical trials.
Rapid pathogen evolution in infectious disease trials requires continuous adaptation and innovation.
Demand for diverse patient populations may strain recruitment capabilities in less diverse regions.
Differentiation
Lindus Health accelerates trials using a unique software platform and 30 million EHRs.
They offer fixed-priced quotes and milestone-based payments, aligning incentives with clients.
Their 'All-in-One CRO' solutions cater to specific therapeutic areas like cardiovascular and infectious diseases.
Upsides
Decentralized trials align with Lindus Health's patient-centric approach, enhancing participant reach.
AI integration in trials complements their goal of accelerating clinical trial timelines.
Wearable technology in trials supports continuous monitoring, beneficial for cardiovascular studies.
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