Senior Statistician

Psi-Cro; Toronto; On-site; CAD 110,000 - 170,000; Full time

Job summary

Psi-Cro in Toronto is seeking a senior biostatistician to lead all biostatistics activities for clinical trials. You will communicate with project teams, clients and vendors, develop and review protocols, perform sample size calculations, and prepare analysis plans.

The role requires MSc in Statistics, expert SAS programming, CDISC ADaM knowledge, and strong regulatory understanding. You will train statisticians, present at investigators' meetings, and support audits while upholding high data

Qualifications

• MSc in Statistics or equivalent required.
• Strong knowledge of statistical methods used in clinical research.
• Experience in analyzing trial data and interpreting results.
• Ability to work with investigators and vendors in English.

Responsibilities

• Lead all biostatistics activities for clinical trials as the responsible project statistician.
• Develop and review statistical sections of protocols and sample size calculations.
• Create and validate SAS programs and analysis datasets.
• Provide statistical analyses and report findings to teams and sponsors.
• Mentor statisticians and SAS programmers on the team.

Skills

Biostatistics expertise

SAS programming

CDISC ADaM knowledge

Clinical trial consulting

English communication

Education

MSc in Statistics

Tools

SAS Software

CDISC ADaM tooling

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 2,700 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

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)
• Ability to work in English

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.