Biostatistician - Clinical Data Management
Location: Remote, Poland (Warsaw)
Company: Sitero - Emerging Leader in Clinical Services & Software Solutions
Job Title: Biostatistician
Function: Clinical Data Management
Description:
The Biostatistician for Clinical Data Systems and Services will provide statistical expertise, comprehensive support, and analysis for clinical studies. This role involves study design, reporting, and regulatory engagement, including FDA and EMEA communications. The candidate should be experienced with CDISC standards, SAS proficiency, and DMC/DSMB support. Additionally, the Biostatistician will actively engage with clients and support sales through expert statistical solutions and SOP development.
Essential Duties and Responsibilities:
Statistical Expertise: Provide comprehensive statistical support and demonstrate strong statistical skills throughout clinical studies.
Statistical Analysis & Interpretation: Conduct statistical analyses of clinical data and interpret results related to drug molecule efficiency and study goals.
Study Design & Reporting:
Calculate sample sizes.
Develop study concepts and protocols.
Create Statistical Analysis Plans (SAP).
Prepare clinical study reports and integrated summaries for regulatory submissions.
Regulatory Engagement:
Prepare statistical documentation for regulatory bodies (FDA, EMEA).
Communicate statistical plans and results in professional forums.
DMC/DSMB Support:
Charter development, SAP, and mock Tables, Listings, and Figures (TLFs).
Perform interim analyses and generate both blinded and unblinded reports.
Organize kick-off meetings.
Regulatory Submission Standards:
Solid understanding of Clinical Data Interchange Standards Consortium (CDISC).
Generate Study Data Tabulation Model (SDTM) and Analysis Data Model (ADaM) specifications.
Ensure quality control of datasets.
SAS Proficiency:
Hands-on experience with SAS.
Create and validate TLFs for NDA and BLA submissions.
Client Interaction & Sales Support:
Understand client statistical and analytical needs.
Provide expert advice and solutions.
Support sales proposals and presentations.
SOP Development:
Create and update Standard Operating Procedures (SOPs) related to statistical processes and regulatory submissions.
Education and Experience Required:
MSc or PhD in Biostatistics or Statistics.
10+ years of experience as a Biostatistician in a CRO/Pharma/Biotech company.
3+ years of team leadership experience in the same industry.
Strong written and verbal communication skills (English proficiency required).
Proficiency in statistical programming languages (SAS, R, or Python).
Expertise in BASE, STAT, MACRO, GRAPH, and understanding of database structures.
Ability to direct and promote teamwork in a multi-disciplinary setting.
Strong knowledge of regulatory guidelines and statistical methodology for clinical development.
Understanding of ICH guidelines.
Experience in coaching and mentoring new team members for efficient onboarding.
Cross-functional collaboration and stakeholder management.
Compensation & Benefits:
Competitive salary and benefits package.
Paid time off.
Healthcare and retirement benefits.
Employment Type: Full Time, Permanent
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