Statistical Programmer

Title: Statistical Programmer - FOUR OPENINGS

Location: Summit, NJ

Duration: Through end of 2018

About the Company:

A Global Pharma company headquartered on the East Coast are seeking a Statistical Programmerfor a range of global studies. The SAS Programmer will work within multiple therapeutic areas, with a focus on Oncology for Hematology.

The Role:

This position provides end-to-end SAS programming support and analysis in SAS throughout all phases of ongoing clinical studies.

Your Main Responsibilities:

* Provide programming input to CRF, SAP, analysis file specifications, and tables, figures, and listings (TFLs) shells.
* Write SAS programs to generate derived analysis datasets, perform analysis, and TFLs.
* Perform ad hoc flexible and rapid programming arising from questions generated from planned analyses and results.
* Perform programming validation to ensure the quality of analysis datasets and programming outputs.
* Ensure consistency and adherence to standards within the project.
* Provide input to the design of the clinical trial database for proper data capture and to ensure data quality.
* Create Data Definition Tables (DDT) and converting TFLs to the required format for eSubmission.
* Provide programming support for the preparation of integrated reports, submissions and post-submission activities.
* Convert, verify and integrate multiple sources of incoming data for the creation of analysis datasets.
* Serve as the lead programmer in support of NDAs, sNDAs.
* Serve as an advisor to programmers assigned to the project to ensure high quality and timely deliverables.
* Serve as a coordinator when multiple programming resources (e.g. CROs or contractors) are used.
* Contribute to the creation, maintenance, and validation of standards for outputs and macros.
* Provide training on SOPs, WPs and standard programs.
* Contribute to the creation of naming conventions and development of the programming environment.
* Oversee the services provided by CROs.

Skills/Knowledge Required:

* Bachelor's Degree in life science, statistics, mathematics, computer science, or related field is required; Master's Degree is preferred.
* 7 plus years Pharmaceutical/CRO industry experience as a SAS programmer supporting clinical trials for regulatory submissions or equivalent experience.
* Demonstrated proficiency in using SAS to produce derived analysis datasets and TFLs.
* Thorough understanding of clinical data structures, relational database structures, and data exchange with alternate data formats.
* Demonstrated skills in using additional software tools and applications (e.g. MS office, XML).
* Demonstrated expertise in the handling and processing of upstream data, e.g., multiple data forms, workflow, eDC, SDTM.
* Demonstrated expertise in providing outputs to meet downstream requirements, e.g., ADaM, Data Definition Table, e-submission.

Why work here?

This is an excellent opportunity to join a fast-paced, hardworking team at a Biotech & Pharma leader on the Fortune 500 list. With over a 90% CEO approval rate and an 80% recommendation rate on Glassdoor, this company is the ideal environment to build your career and excel as a SAS programmer.

Additional Details:

  • Duration = to end of year, probable extension (no guarantees)
    Typical Daily Work Hours = 8am to 5pm, 40 hr/wk (with some flexibility in start/end times)
    Weekend & OT work very rare, but candidates should be open to it, if needed.
    100% onsite work.

Sthree US is acting as an Employment Business in relation to this vacancy.