Expertise in statistical principles and methods in clinical research
Proficiency in advanced statistical techniques for study analysis
Skilled in consulting with clinical investigators on statistical strategies
Expert SAS programming knowledge needed
Strong understanding of CDISC ADaM standards
Familiarity with relevant regulations (FDA, EMA, ICH)
English proficiency required
Responsibilities
Lead biostatistics activities for clinical trials as project statistician
Communicate statistical queries to project teams, clients, and vendors
Develop and review statistical protocol sections, including sample size calculations
Create statistical analysis plans and database structures
Define SAS programming requirements and specifications
Conduct SAS programming and ensure program validation
Review and QC statistical outputs like tables and figures
Perform statistical analysis and report findings
Consult on experimental design and safety/efficacy assessments
Coordinate with Data Management on data transfer issues
Participate in bid defense and kick-off meetings
Train junior statisticians and SAS programmers
Prepare presentations for investigators' meetings
Address and resolve audit findings and recommendations
Benefits
Opportunities for professional training and development
Engagement in high-impact clinical trials
Collaboration with diverse teams and clients
Flexible work environment
Exposure to cutting-edge statistical methodologies
Full Job Description
Job Description
In this role, you will:
Lead all biostatistics activities related to clinical trials as responsible project statistician
Communicate with project teams, clients and vendors on statistical questions
Develop and review statistical sections of protocols, including sample size calculations
Develop statistical analysis plans
Develop and document analysis database structures (i.e. SAS analysis data set structures)
Develop SAS program requirements and specifications
SAS programming and program validation
Review and QC of statistical deliverables (tables, listings, figures, etc.)
Perform statistical analysis and report results
Consult on experimental design, statistical methods and approaches for the purpose of assessing safety and efficacy of drug products
Liaise with DM on statistical questions related to data issues, including coordination of data transfers from DM to Statistics
Participate in bid defense meetings and kick-off meetings
Train statisticians and SAS programmers
Prepare and deliver presentations at investigators' meetings
Address audits findings/recommendations, and follow-up on and resolution of audit findings
Qualifications
MSc in Statistics or equivalent
Expert knowledge and understanding of the statistical principles, concepts, methods, and standards used in clinical research
Ability to apply a range of advanced statistical techniques in support of clinical research studies and to analyze, interpret, and draw conclusions from complex statistical information
Ability to consult with clinical investigators, interpret research requirements, and determine statistical analysis strategies
Expert knowledge and understanding of the SAS programming
Expert knowledge and understanding of CDISC ADaM standard
Knowledge of relevant regulations and guidelines (e.g. FDA, EMA, ICH)
