Principal Statistician

PSI CRO; United States; On-site; USD 120,000 - 190,000; Full time

Job summary

PSI CRO in the United States is seeking a Biostatistics Project Lead to contribute to statistical activities for global clinical trials and to lead teams of statisticians and SAS programmers. You will work with international teams to develop SAPs, ADaM datasets, and analysis plans, and ensure high-quality deliverables.

The role emphasizes strong communication, regulatory knowledge (FDA/ICH), and the ability to manage multiple projects from protocol to reporting in a dynamic CRO environment.

Qualifications

• MSc in Statistics or an equivalent qualification.
• Expert knowledge of statistical principles used in clinical research.
• Experience with SAS programming.
• Experience with CDISC ADaM.
• Knowledge of adaptive designs and sample size calculation.
• Familiarity with FDA/EMA/ICH guidelines.
• Strong communication and presentation skills.

Responsibilities

• Act as a communication line for project teams, clients, vendors and internal teams on statistical questions.
• Conduct statistical analyses for clinical trials including interim, final, DSMB/DMC and PK analyses.
• Develop and review SAPs, analysis datasets, and ADaM specifications.
• Review statistical deliverables such as tables, figures, listings and datasets.
• Lead and train statisticians and SAS programmers on projects.
• Support audits and contribute to QSD documents for Biostatistics.
• Collaborate with DM on data-related statistical questions.
• Participate in bid defense and kick-off meetings.

Skills

Statistical methods

SAS programming

Regulatory knowledge

Leadership

Communication

Education

MSc in Statistics or equivalent

Tools

SAS programming

CDISC ADaM

Adaptive designs

Sample size calculation

Job description

We are the company that cares – for our staff, for our clients, for our partners and for the quality of work we do. A dynamic, global company founded in 1995, we bring together more than 3,000 driven, dedicated and passionate individuals. We work on the frontline of medical science, changing lives, and bringing new medicines to those who need them.

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

Additional Information

Our mission is to be the best CRO in the world as measured by our employees, clients, sites, and vendors. Our recruitment process is easy and straightforward, and we’ll be there with you every step of the way.