Senior Statistician

PSI CRO - Remote

Full-timeEstimated: $80,000 - $110,000 a year
Job Description

Position Overview: Reporting to the Director of Biostatistics, the Senior Statistician is an integral part of our team here at PSI. If you have experience in clinical research, understand SAS programming principles and concepts, and have a good knowledge of statistical methods, apply today!

US Remote Position

The scope of responsibilities will include

Primary responibilities

Leading all biostatistics activities related to clinical trials as responsible project statistician
Development and review of statistical sections of protocols, including sample size calculations
Development of statistical analysis plans
Development and documentation of analysis database structures (i.e. SAS analysis dataset structures)
Development of SAS program requirements and specifications
SAS programming and program validation
Review and QC of statistical deliverables (tables, listings, figures, etc.)
Performing statistical analysis and reporting results
Providing consultation on experimental design, statistical methods, and approaches for the purpose of assessing safety and efficacy of drug products
Liaison with DM on statistical questions related to data issues, including coordination of data transfers from DM to Statistics
Corporate/Departmental Assignments

Participation in bid defense meetings
Participation in kick-off meetings
Communication line for project teams, including statisticians and SAS Programmers
Communication line for customer on statistical questions
Communication line for vendors on statistical questions

Conduct of project-specific training of statisticians and SAS programmers
Coaching and training of statisticians (non-project-related)
Preparation and delivery of presentations at investigators' meetings
Quality Assurance

Preparation for and attendance at internal and third-party study audits pertinent to Statistics
Preparation of the answers to the internal/external audits findings/recommendations, and follow-up on and resolution of audit findings
Participation in the development of guidelines, procedures and other Quality Systems Documents (QSDs) pertinent to activities of the Biostatistics department


Minimum Education

MSc in Statistics or equivalent

At least 5 years of industry experience in clinical research
At least 5 years of industry experience in biostatistics
At least 5 years of experience in SAS programming
Expert knowledge and understanding of the statistical principles, concepts, methods, and standards used in clinical research
Very Good knowledge and understanding of the SAS programming language
Strong 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
Strong ability to consult with clinical investigators, interpret research requirements, and determine statistical analysis strategies
Strong ability to represent biostatistics in bid defenses
Strong knowledge of relevant regulations and guidelines (e.g. FDA, EMA, ICH)

Excellent presentation and communication skills
Advanced knowledge of SAS software
Good knowledge of MS office software
Advanced knowledge of CDISC ADaM IG 1.0 or later, define1-0-0.xml and define2-0-0.xml specifications
Knowledge of CDISC SDTM IG 3.1.3 or later and nQuery Advisor software is a plus

Additional Information

All your information will be kept confidential according to EEO guidelines.