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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>
Date: September 9, 2018 at 5:45:56 PM PDT
To: d-ssc@ssc.ca
Subject: [d-ssc] Full Time Permanent Position Available: Consultant, SAS Clinical Data Management with ApoPharma Inc.

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.

Thank you,


Noemi

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