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Consultant, SAS Clinical Data Management with ApoPharma Inc.- Full time Permanent Position
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
- 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
- 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
- Provides input into the development/updating of SOPs for SAS
- 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.
- 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
- 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.