Clinchoice Inc.

Senior statistician Consultant- V&I (Vaccines & Infectious Diseases)

United States · Senior

Sponsorship not specifiedDetected 26 days ago

Computer VisionStatisticsStakeholder ManagementClinical TrialsFDA RegulatoryMedical DevicesSASCommunicationBiostatistics

About the role

The role involves leading statistical strategy, analysis, and reporting for clinical trials, ensuring high-quality deliverables aligned with regulatory standards.

Lead statistical input for clinical trial design, including protocol development and sample size calculations
Develop and review Statistical Analysis Plans (SAPs)
Collaborate with cross-functional teams including Clinical, Data Management, and Programming

5+ years of experience in clinical trials within pharma/CRO
Strong experience in Vaccines & Infectious Diseases
In-depth knowledge of clinical trial methodology and statistical principles
Experience with regulatory submissions (FDA/EMA)
Strong understanding of CDISC (SDTM/ADaM) standards
Unfortunately, due to the number of applications we receive, we cannot reply to everyone individually if you are not successful.
We have over 28 years of proven high-quality delivery and results across all our services, with over 4,000 professionals in more than 20 countries across the Americas, Europe, and Asia-Pacific.

Support regulatory submissions (e.g., FDA, EMA) including responses to health authority queries

to contribute to a healthier and safer world by accelerating the development and commercialization of innovative drugs and devices.
Our employees are the most valuable company asset and they are the fulcrum around which all ClinChoice activities are built and close management and training is the core instrument to develop and maintain highly-qualified personnel.
The continuous training keeps the resources qualified in terms of competence and expertise and gives all personnel the clear tools needed to manage both internal and client processes with the same methodology.
The success of these core values is evidenced by our below industry average turnover rates.
ClinChoice is an equal opportunity employer.
We have based our success on attracting, developing, and promoting talent guided by diversity and inclusivity.

Are you interested in working directly for a single sponsor while having the security and additional career opportunities that working for a global CRO can bring

This listing is sourced directly from Clinchoice Inc.'s careers page and normalized into a canonical job model.