Principal Statistician – Ophthalmology

This is a fully remote position, open to applicants in Spain, +4 more states.

📋 Description

• Act as a resource and mentor for biostatisticians within the statistical department

• Design and deliver training sessions for Biostatistics associates and new employees

• Supervise biostatistics personnel on assigned projects

• Conduct independent reviews of project outputs generated by other biostatisticians

• Assist with statistical tasks throughout the entire project lifecycle, from protocol development to Clinical Study Report (CSR)

• Prepare or oversee the creation of Statistical Analysis Plans, along with mock-up tables, listings, and figures

• Take charge of the statistical components of protocols, randomization schedules, and clinical study reports when assigned

• Develop or assess programming specifications for analysis datasets, tables, listings, and figures

• Review annotated Case Report Forms (CRFs), database design, and study documentation

• Represent the Biostatistics team on project groups and collaborate with departmental representatives and sponsors

• Conduct verification and quality control on project deliverables

• Lead complex or multiple projects and assist with regulatory agency meetings or responses

• Manage project schedules, milestones, priorities, timelines, and out-of-scope escalations

• Provide statistical programming assistance as required

• Engage in Data Safety Monitoring Board (DSMB)/Data Monitoring Committee (DMC) activities, including charter development and fulfilling statistician roles

• Adhere to relevant SOPs, Work Instructions (WIs), and regulatory guidelines while maintaining inspection-ready documentation

• Contribute to business development through proposals, budgeting, and sponsor bid defense meetings

• Carry out additional assigned work-related responsibilities

⛳️ Requirements

• Advanced degree in biostatistics or a related field

• Significant experience in clinical trials or equivalent education and experience demonstrated through the ability to manage multiple projects and study programs

• Proficiency in R programming language

• Deep understanding of statistical design, analysis, regulatory guidelines, and programming methodologies used in clinical research

• Capability to effectively communicate statistical concepts

• Experience in statistical tasks supporting clinical trials from protocol creation to CSR

• Familiarity with regulatory submissions is preferred

• Outstanding written and verbal communication skills

• Ability to read, write, speak, and comprehend English

🏝️ Benefits

• Opportunities for career development and advancement

• Supportive and engaged management

• Technical and therapeutic area training

• Recognition from peers

• Comprehensive total rewards program

• Inclusive company culture

• Access to extensive resources including emerging technologies, data, science, and knowledge sharing

• Minimal travel may be required