SAS Clinical Consultant

Toronto - Ontario - Canada - Life Sciences & Health Care - Pharmaceutical - Embedded Software - Academic Bachelor

We're hiring a SAS Clinical Consultant for our client, who is a Pharmaceutical company based in Toronto, This is a 12 month contract.

Feel free to contact

Diana Grodowski, Account manager

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About this role

Responsibilities

  • Contributes Clinical Data Management deliverable(s) as requested, for documents such as Clinical Study Reports, annual reports, statistical analysis plans, Data Safety Monitoring Board (DSMB) submissions, Integrated Safety and Efficacy summaries, regulatory submissions, publications and any ad hoc requests.
  • Writes, validates and maintains SAS programs to generate SAS datasets, spreadsheets, ASCII files, data listings, tables and graphical displays of clinical trial and safety data.
  • Performs and documents Quality Control checks of any outputs as requested. Builds edit checks in SAS to supplement edit checks within the database, looking for trends that could indicate problems with protocol adherence or data issues.
  • Assists in any SAS activities needed to ensure timely database lock (e.g. producing listings for review of data, quality control checks or blinded analyses dataset creation).
  • Develops Case Report Tabulations and associated documentation for submissions using advanced knowledge of CDISC standards.
  • Transforms various formats (e.g. Excel, csv, ASCII) received from both internal and external clients into SAS datasets and transport files.
  • Supports CDM in queries surrounding the SAS application and outputs.
  • May participate in upgrade and integration projects with IS.
  • Works collaboratively with Clinical Data Management, Biostatisticians, Clinical Research, Medical Safety, Regulatory Affairs and Project Management staff to meet project deliverables and timelines for statistical programming and reporting.
  • Keeps current with news from the SAS institute and user group societies.
  • Provides support, for the management of SAS activities by CROs.
  • Demonstrates the use of advanced problem solving techniques to resolve SAS process issues with internal/external customers. Utilizes advanced problem solving techniques in the assessment and application of best practices for SAS programming.
  • Demonstrates ability to make sound decisions on complex issues related to daily activities and refers contentious issues with recommendations to the next level.May be involved in the management of routine contracts between CROs or Vendors producing SAS deliverables on behalf of CDM for projects. Suggests to CDM Management ways of improving processes through the utilization of SAS outputs.
  • Participates in the preparation of resolutions to data management issues found in QA audits through the use of the SAS application.

About you

Requirements

  • Bachelor’s Degree in a related field required (e.g. Statistics, Computer Science), Masters preferred.
  • Proven SAS experience and expertise as demonstrated in previous work
  • Knowledge of CDISC standards programming is necessary.
  • SAS certification and/or A.Stat or P.Stat accreditation are assets.
  • An understanding of relevant safety and efficacy ICH guidelines as well as relevant clinical trials regulations.
  • Experience with relational databases is required.
  • Competent with computer software packages (i.e. proficient in Microsoft Office applications, Internet, Adobe Acrobat Exchange, and relational databases).
  • Strong interpersonal and verbal/written communication skills.
  • Demonstrated effective organizational and time-management skills. Ability to manage multiple priorities in an efficient manner.
  • Demonstrated ability to work independently and as part of a team.

What we offer

Why work with Brunel? We are proud to offer exciting career opportunities from over 100 offices globally in 42 countries. Advancing your career takes time and effort – let us match you to your ideal position.

About us

Brunel has a reputation for working with some of the best in the business. That’s what we continually strive for. Over 40 years, we’ve created a global network of interesting clients and talented individuals working together through a vast array of services.

Summary

  • Vacancy number: PUB233889
  • Location: Toronto
  • Market: Life Sciences & Health Care
  • hours per week: 40
  • Branch: Pharmaceutical
  • Education level: Academic Bachelor
  • Area of Expertise: Embedded Software
  • Closing date: Tuesday, September 29, 2020
Apply now

Feel free to contact

DG

Diana Grodowski

Account manager Brunel Canada Toronto

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