Principal Biostatistician
Location: Warsaw, Poland (Remote)
Department: Service Delivery
Employment Type: Full-Time
Minimum Experience: Experienced
Job Title:
Principal Biostatistician
Company Overview:
Sitero is a growing leader in Clinical services and software solutions for the life sciences industry. With broad expertise across therapeutic areas, we focus on innovative, technology-enabled solutions that help clients stay focused on their core strengths. From early-phase through Phase III clinical trials, our team ensures safety, compliance, and innovation for all stakeholders in the clinical research ecosystem.
Function:
Clinical Data Management
Description:
The Principal Biostatistician in Clinical Data Systems and Services brings extensive statistical expertise to support and analyze clinical studies. This role involves designing studies, performing statistical analyses, engaging with global regulatory bodies, and delivering expert client support. Proficiency in CDISC standards, SAS, and DSMB support is essential. The role also supports business development and SOP creation.
Essential Duties and Responsibilities:
Statistical Expertise:
Provide comprehensive statistical support across clinical studies.
Apply advanced statistical principles with accuracy and efficiency.
Statistical Analysis and Interpretation:
Perform statistical analyses and interpret clinical data related to drug safety and efficacy.
Study Design and Reporting:
Calculate sample sizes and develop concepts, protocols, and Statistical Analysis Plans (SAPs).
Prepare Clinical Study Reports (CSRs) and integrated summaries for regulatory submissions.
Regulatory Engagement:
Collaborate with regulatory authorities (FDA, EMEA), preparing statistical documents and presenting results professionally.
DMC/DSMB Support:
Support DMC/DSMB activities, including charter creation, interim analyses, and development of blinded/unblinded reports.
Prepare SAPs and mock TLFs, organize meetings and kickoff sessions.
Regulatory Submission Standards:
Ensure compliance with CDISC standards, including SDTM and ADaM.
Generate and quality-check datasets for submission readiness.
SAS Proficiency:
Strong hands-on experience with SAS for TLF development and validation, particularly for NDA/BLA submissions.
Client Interaction and Sales Support:
Consult with clients on statistical needs and offer tailored solutions.
Contribute to proposals, presentations, and discussions during the sales cycle.
SOP Development:
Develop and update SOPs for statistical processes and regulatory workflows.
Education and Experience Required:
MSc or PhD in Biostatistics or Statistics
10+ years of experience as a Biostatistician in CRO/Pharma/Biotech settings
3+ years of leadership experience managing biostatistics and programming teams
Proficient in SAS, R, or Python; expertise in BASE, STAT, MACRO, GRAPH modules
Strong communication skills, fluent in English
Deep understanding of database structures and regulatory guidelines (ICH)
Skilled in stakeholder management, mentoring, and cross-functional collaboration
Compensation & Benefits:
Competitive salary
Paid time off
Healthcare and retirement benefits
Employment Type:
Full-Time, Permanent
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