Job Description :
Position : SAS Programmer

Location : Morristown NJ

Interview : Phone then f2f

Job Description:

Must have at least 4 years current experience within the pharmaceutical industry ( Pharma. Biotech , CRO ) working as a SAS/Statistical Programmer.



Must be able to problem solve - plan - make timely decisions - delegate - set priorities - manage conflicts - possess interpersonal savvy - composure - and presentation skills.



Great Communication skills is paramount



Programmer will have to validate large datasets from CRO’s



- Individual contributor with specialized knowledge.

- Has an easily discernible impact on the job area and expected results.

COMPLEXITY/INNOVATION

- Executes work procedures in a project context. Consistently exercises judgment and discretion within generally defined procedures.

- Technical expert with sufficient expertise and experience to be considered for sensitive or complex assignments.

- Called upon to develop solutions utilizing creativity and ingenuity.

COMMUNICATION

Presents concepts, facts, and reports to mid-level internal and external clients to advise of key trends and issues.

Contact with clients and external vendors and troubleshooting routine client inquiries. May represent the organization as a prime contact for technical matters of significant complexity.

STATISTICAL ANALYSIS.

- Reviews SAP, TLG shells and variable derivation rules and provides feedback.

MONITORING

- Reviews Study Quality Surveillance Plan and Data Monitoring Committee charter.

- Implements the monitoring plan set by the statistician and produces the needed datasets and TLGs.

CLINICAL STUDY REPORT/INTEGRATION:

- Reviews the SAP, provides feedback to the statistician and develops (with the statistician) study specific datasets.

- Develops programs for the creation and validation of datasets (SDTM & ADaM) and TLGs.

- Integrates multiple studies in support of an ISS/ ISE.

- Supports ad-hoc, interim, exploratory, publications and performs programming and generates outputs.

- Maintains data, programs and reports in accordance with 21 CFR part 11.

REGULATORY INTERACTION:

- Creates / validates the eSubmission components (transport datasets for both SDTM & ADaM, Annotated CRF, define documents)

RESOURCE MANAGEMENT

- Makes recommendations for improving resources (tools, systems, vendors, etc needed by the team.

- Manages the workflow of others to ensure work is done within a given deadline.

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FINANCIAL MANAGEMENT

- May assist the review of 3rd party (contractors, consultants and vendors) work product and deliverables to recommend approval of payment of invoices or escalates issues when appropriate.

MATRIX AND TEAM MANAGEMENT

- Provides feedback, sets clear tasks and objectives







Desired Skills and Experience

- Experience in clinical development statistical programming methods and processes in industry setting required.

- Foundational proficiency in statistical analysis.

- Intermediate proficiency in statistical programming.

- Foundational proficiency in regulatory process for biostatistics.

- Foundational proficiency in business knowledge.

- Foundational proficiency in regulatory knowledge.

- Foundational proficiency in project and resource management.