Principal Statistician

Psi CRO Ag; Durham (NC); On-site; USD 80,000 - 120,000; Full time

Job summary

Psi CRO Ag is seeking a Statistical Project Lead in Durham, North Carolina. The ideal candidate will be responsible for leading statistical activities in global clinical trials, conducting various statistical analyses, and ensuring compliance with industry standards. A Master's in Statistics and expert knowledge of SAS programming and clinical research methods are essential. Strong communication and leadership skills are necessary as you will work with cross-functional teams. This role offers an opportunity to contribute to significant clinical projects.

Qualifications

• Expertise in statistics and SAS programming required.
• Ability to lead teams and support clinical research projects.
• Knowledge of regulations and guidelines like FDA, EMA, ICH.

Responsibilities

• Lead statistical activities for global clinical trials.
• Conduct statistical analysis including interim and final analyses.
• Develop and review study protocols and statistical analysis plans.
• Prepare for and attend internal and external audits.

Skills

Expert knowledge of statistical principles

Expert knowledge of SAS programming

Expert knowledge of CDISC ADaM standard

Expert knowledge of adaptive designs

Expert knowledge of sample size calculation

Strong presentation skills

Strong communication skills

Education

MSc in Statistics or equivalent

Job description

Job Description

You will contribute to statistical activities related to global clinical trials and work closely with international teams of statisticians, programmers and data managers, including the role of biostatistics project lead.

In this role, you will:

• Act as a communication line for project teams, clients, vendors and internal team on statistical questions
• Conduct statistical analysis for clinical trials including, interim analysis, final analysis, analysis for DSMBs/DMCs and PK analysis
• Develop and review study protocols, statistical analysis plans, analysis dataset specifications according to CDISC ADaM standard and other project-specific documents
• Review statistical deliverables such as tables, figures, listings and analysis datasets
• Conduct departmental induction course and project-specific training for statisticians and SAS programmers
• Prepare for and attend internal and external study audits pertinent to Statistics
• Participate in preparation of internal/external audits follow up
• Provide input to standard operating procedures and other Quality Systems Documents (QSDs) pertinent to activities of Biostatistics department
• Liaise with DM on statistical questions related to data issues
• Participate in bid defense and in kick-off meetings
• Lead teams of SAS programmers and/or statisticians on the project level

Qualifications

• MSc in Statistics or equivalent
• Expert knowledge and understanding of the statistical principles, concepts, methods, and standards used in clinical research
• Expert knowledge and understanding of the SAS programming
• Expert knowledge and understanding of CDISC ADaM standard
• Expert knowledge and understanding of adaptive designs
• Expert knowledge and understanding of sample size calculation
• Expert knowledge and understanding of relevant regulations and guidelines (e.g. FDA, EMA, ICH)
• Ability to apply 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
• Strong presentation and communication skills