Principal Biostatistician
Department: Service Delivery
Employment Type: Full-Time
Minimum Experience: Experienced
Location: Poland (Remote)
Company Overview:
Sitero is an emerging leader in Clinical services and software solutions for the life sciences industry. With deep expertise across diverse therapeutic areas, Sitero focuses on delivering innovative, technology-enabled solutions that allow clients to concentrate on their core strengths. From early-phase studies through Phase III clinical trials, Sitero’s experienced team provides high-touch services that emphasize ethics, compliance, and innovation.
Job Title: Principal Biostatistician
Function: Clinical Data Management
Description:
The Principal Biostatistician will bring strong statistical expertise to support clinical studies across multiple phases. This role involves study design, comprehensive data analysis, regulatory engagement with bodies such as the FDA and EMEA, and client-facing collaboration. The ideal candidate is skilled in CDISC standards, proficient in SAS, and experienced in DMC/DSMB support and SOP development.
Essential Duties and Responsibilities:
Statistical Expertise: Provide comprehensive statistical support with a robust understanding of statistical principles.
Statistical Analysis and Interpretation: Perform statistical analyses of clinical data and interpret results for drug efficiency and safety evaluations.
Study Design and Reporting: Calculate sample sizes, develop study protocols, create Statistical Analysis Plans (SAP), and prepare clinical study reports for regulatory submissions.
Regulatory Engagement: Prepare and present statistical documentation to regulatory agencies, effectively communicating statistical plans and outcomes.
DMC/DSMB Support: Develop DMC/DSMB charters, SAPs, mock TLFs, and manage interim analysis reporting.
Regulatory Submission Standards: Implement CDISC requirements for regulatory submissions, including SDTM and ADaM specifications and dataset quality control.
SAS Proficiency: Conduct statistical analyses using SAS and validate TLFs for NDA/BLA submissions.
Client Interaction and Sales Support: Engage clients to provide expert statistical consultation and support the sales cycle through proposals and presentations.
SOP Development: Create and maintain SOPs related to statistical methodologies and regulatory submissions.
Education and Experience Required:
MSc or PhD in Biostatistics or Statistics.
10+ years of experience as a Biostatistician in CRO/Pharma/Biotech industries.
3+ years of experience leading teams of biostatisticians and statistical programmers.
Strong proficiency in English with the ability to explain complex statistical concepts to non-statisticians.
Proficient in statistical programming languages such as SAS, R, or Python.
Expertise in BASE, STAT, MACRO, and GRAPH modules.
Strong understanding of database structures and TLFs development.
Excellent teamwork, coaching, cross-functional collaboration, and stakeholder management skills.
In-depth knowledge of ICH guidelines and regulatory requirements for clinical development.
Compensation and Benefits:
Sitero offers a competitive compensation package, including salary, paid time off, healthcare, and retirement benefits.
Employment Type:
Full Time, Permanent
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