Senior Statistician

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!

The Senior Statisticianrole is a remote-based position.

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

Training

• 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

Qualifications

• 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.