Senior/Principal Statistician with focus on Immunology studies_FTE-Remote
In OfficePrincipalNAClinical ResearchMedical DevicesPharmaceuticalsStatisticianPrincipalTeam ManagementReportingDocumentationClinical TrialsSAS
Upload My Resume
Drop here or click to browse · PDF, DOCX, TXT
Requirements
- MS or PhD in Statistics, Biostatistics, or a related field
- Strong experience in Immunology clinical studies (required)
- Strong experience in Immunology clinical studies
- Proven ability to lead projects and studies independently
- lead projects and studies independently
- Statistical Analysis Plans (SAPs)
- Analysis Database Specifications
- Reviewing and interpreting analysis results
- SAS programming skills required (hands-on or strong working knowledge)
- Excellent written and verbal communication skills
- Experience working in a CRO and/or pharmaceutical/biotech environment
- Experience leading Phase II–III clinical trials
- Prior interaction with regulatory agencies
- Experience mentoring junior statisticians or programmers
- The Application Process
- Once you have submitted your CV, you will receive an acknowledgement that we received it. If you have the requirements we need, you will be invited for phone interview as the first step. Unfortunately, due to the number of applications we receive, we cannot reply to everyone individually if you are not successful.
- Who will you be working for?
- ClinChoice is a global full-service CRO specializing in clinical development and functional solutions for pharmaceutical, biotechnology, medical device, and consumer health companies. 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.
- Our Company Ethos
- Our Company Ethos
- Our mission drives our culture: 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.
Responsibilities
- Lead and provide statistical support for clinical studies, primarily within Immunology therapeutic areas
- Immunology therapeutic areas
- Act as the lead statistician on assigned studies, overseeing statistical strategy and deliverables
- lead statistician
- Author and review key statistical documents, including:
- Statistical Analysis Plans (SAPs)
- Analysis Database Specifications (ADS)
- Statistical sections of clinical study reports
- Review and interpret analysis outputs, ensuring accuracy, quality, and regulatory compliance
- Collaborate with cross-functional teams including Clinical, Programming, Data Management, and Regulatory
- Provide guidance and oversight to statistical programmers as needed
- Communicate statistical concepts, results, and risks clearly to both technical and non-technical stakeholders
- Ensure adherence to regulatory standards (FDA, ICH, GCP) and company SOPs
Benefits
- Remote work option available.
- Security of working directly with a single sponsor while having additional career opportunities within the global CRO environment.
- Compliance with regulatory standards and company SOPs ensuring job security in terms of adherence to industry regulations.
Similar Jobs
5h ago
5h ago