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Fwd: [d-ssc] Job available (full time): Consultant, SAS Clinical Data Management at ApoPharma Inc. (Apotex group of Companies)





Begin forwarded message:

From: Noemi Toiber Temin <noemi.tt@gmail.com>
Subject: [d-ssc] Job available (full time): Consultant, SAS Clinical Data Management at ApoPharma Inc. (Apotex group of Companies)
Date: April 23, 2018 at 11:36:30 AM PDT


Job description:

​Hi There,


Here is the link to the job description (you can apply through here):



as well as pasted here:

Consultant, SAS Clinical Data Management


    Apotex Inc.

    Toronto, Canada Area


    Serves as a technical specialist in the SAS application providing support to CDM and other units in ApoPharma. This includes but is not limited to the preparation, validation and maintenance of SAS programs to generate SAS datasets, spreadsheets, ASCII files, data listings, tables and graphical displays of clinical trial and safety data for ApoPharma products. May participate in the efforts for process improvement and technology upgrades regarding SAS technology and data standards. Works collaboratively with other units at ApoPharma to meet project deliverables and timelines for statistical programming and reporting.




      Job Responsibilities 

       
      • Contributes Clinical Data Management deliverables 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 ApoPharma projects. Suggests to CDM Management ways of improving processes through the utilization of SAS outputs.
      • Displays good project and data management skills when performing SAS programming activities.
      • Shows initiative in keeping self at the “leading-edge” of their field
      • Ensures that all SAS programming activities within a project are compliant with internal standard operating procedures. This includes performing Quality Control checks on any data submitted to internal and external customers.
      • Provides input into the development/updating of SOPs for SAS programming processes.
      • Ensures that all work is performed in full compliance with Good Clinical Practices, Good Clinical Data Management Practices, Standard Operating Procedures and established safety standards.
      • Participates in the preparation of resolutions to data management issues found in QA audits through the use of the SAS application.
      • Works as a member of a team to achieve all outcomes.
      • Performs all work in support of our Corporate Values of Pride, Accountability, Integrity and Diligence; Demonstrates strong and visible support of our values.
      • Performs all work in accordance with all established regulatory and compliance and safety requirements.
      • All other duties as assigned.



      Job 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.


      At Apotex, we are committed to fostering an inclusive, accessible work environment, where all employees feel valued, respected and supported.

       

      Apotex offers accommodation for applicants with disabilities as part of its recruitment process. If you are contacted to arrange for an interview or testing, please advise us if you require an accommodation


      Thank you,

      Noemi


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