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Fwd: [d-ssc] Job posting open immediately Consultant SAS, Clinical Data Management with ApoPharma Inc. (member of the Apotex group of companies)
----- Forwarded Message -----
From: "Noemi Toiber Temin" <firstname.lastname@example.org>
Sent: Wednesday, November 2, 2016 3:00:47 PM
Subject: [d-ssc] Job posting open immediately Consultant SAS, Clinical Data Management with ApoPharma Inc. (member of the Apotex group of companies)
Please find below the description of the job posting available immediately:
If interested please contact Connie Meli at email@example.com
Consultant SAS, Clinical Data Management
Clinical Data Management (CDM), Medical Affairs
Serves as a technical specialist in the SAS application providing support to both CDM and Biostatistics at ApoPharma during the clinical drug development process. This includes but is not limited to the preparation, validation and maintenance of SAS programs and macros to generate SAS datasets, spreadsheets, ASCII files, data listings, tables and graphical displays of clinical trial data and safety data for ApoPharma products. May participate in the efforts for process improvement and technology upgrades regarding SAS technology. Works collaboratively with Clinical Data Management, Biostatisticians, Clinical Research, Medical Safety, Regulatory Affairs and Project Management at ApoPharma to meet project deliverables and timelines for clinical statistical programming and reporting. Job Responsibilities:
1. Prepares deliverables as per work plan to deliver SAS outputs for Clinical Data Management, Clinical Study Reports, annual reports, Data Safety Monitoring Board (DSMB) submissions, Integrated Safety and Efficacy summaries, publications and ad hoc requests.
2. Writes, validates and maintains SAS programs to generate SAS datasets, spreadsheets, ASCII files, data listings, tables and graphical displays of clinical trial data.
3. Merges datasets, as required for Integrated Summaries.
4. Assists the Biostatisticians at ApoPharma with SAS outputs and formatting for Statistical Analysis.
5. Performs and documents Quality Control checks of SAS or other programming produced by the Biostatistics group or CDM group, as requested by the Scientific Leader Biostatistics or Head CDM.
6. Contributes to the Statistical Analysis Plan by producing mock-up table shells, as requested by the Scientific Leader Biostatistics, for various appendices.
7. Builds edit checks in SAS to supplement edit checks in the database, looking for trends that could indicate problems with protocol adherence or data issues.
8. 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).
9. Develops Case Report Tabulations and associated documentation for submissions using advanced knowledge of CDISC standards.
10. Transforms various formats (e.g. Excel, csv, ASCII) received from both internal and external clients into SAS datasets and transport files.
11. Creates SAS reports in support of the maintenance of the CDM website and Electronic Data Capture website.
12. Responsible for other assigned duties, as required.
13. Supports CDM in queries surrounding the SAS application and outputs.
14. May participate in upgrade and integration projects with IS.
15. Works collaboratively with Clinical Data Management, Biostatisticians, Clinical Research, Medical Safety, Regulatory Affairs and Project Management staff to meet project deliverables and timelines for clinical statistical programming and reporting.
16. Keeps current with news from the SAS institute and user group societies.
17. Provides support, as requested by the Scientific Leader, Biostatistics, for the management of SAS activities by CROs.
18. 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. Participates in any improvement process with the Scientific Leader Biostatistics.
19. Demonstrates ability to make sound decisions on complex issues related to daily activities and refers contentious issues with recommendations to the next level.
20. May be involved in the management of routine contracts between CROs or Vendors producing SAS deliverables on behalf of CDM for ApoPharma projects as requested by the Scientific Leader Biostatistics or Head CDM.Suggests to CDM Management ways of improving processes through the utilization of SAS outputs.
21. Displays good project management skills when performing SAS programming activities.
22. Shows initiative in keeping self at the “leading-edge” of their field
23. 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.
24. Provides input into the development/updating of SOPs for SAS programming processes.
25. 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.
26. Participates in the preparation of resolutions to data management issues found in QA audits through the use of the SAS application.
27. Works as a member of a team to achieve all outcomes.
28. Performs all work in support of our Corporate Values of Pride, Accountability, Integrity and Diligence; Demonstrates strong and visible support of our values.
29. Performs all work in accordance with all established regulatory and compliance and safety requirements.
30. 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 standard 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.
Noemi Toiber Temin, MA Statistics, P. Stat.
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