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Fwd: [d-ssc] Full Time Permanent Position Available: Consultant, SAS Clinical Data Management with ApoPharma Inc.





Begin forwarded message:

From: Noemi Toiber Temin <noemi.tt@gmail.com>
Subject: [d-ssc] Full Time Permanent Position Available: Consultant, SAS Clinical Data Management with ApoPharma Inc.
Date: August 14, 2018 at 2:44:02 PM PDT

Please post, thank you!

Consultant, SAS Clinical Data Management with ApoPharma Inc.- Full time Permanent Position
Toronto

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

Noemi.tt@gmail.com

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