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Statistical Programmer

Bothell, WA, USA

Job Type

Full Time

Workspace

On-Site

About the Role

Programming:
1. Read and understand Clinical study protocol, Statistical Analysis Plan, Case Report Form (CRF), specifications and other study related documents
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2. Develop SAS programs to produce Analysis datasets, statistical tables, graphical representations, and data listings for individual study reports in accordance with the Statistical Analysis Plan (SAP).

Compliance:
1. Understand and comply with ICH guidelines, Ephicacy standard operating procedures (SOP) and work instructions.

2. Participate in the ongoing review of the processes used by the Statistical Programming group and provide input to ensure processes are continually improved.

3. Adapt quality policies and guidelines as recommended by USFDA, EU, WHO, and ANVISA thereby keeping abreast with the current regulations.

4. Create, maintain and update project related documentation regularly.

5. Abide by the information security related policies and procedures ensuring confidentiality, integrity and availability of information assets, created and maintained by Ephicacy and highlight the risks involved regarding the same.

Support/ Ad-hoc responsibilities:
1. Communicate with project team/stakeholders/ other departments and/or groups effectively.

2. Provide support to Data Management in developing Edit check programs, listings or ad hoc reports as required.

3. Prepare and review randomization schedule as per protocol.

4. Support programming team towards resolving study/program related issues and thereby efficiently meet all project timelines & deliver quality outputs.
site.

Requirements

Bachelors in Computer Science, Engineering and Related plus 5 years of Experience.

About the Company

ProKlin T Inc, as a technology consulting company endeavors to serve the Bio-Tech, Pharmaceutical and Healthcare industry by providing innovative, efficient and cost-effective solutions/services to the growing data science and analytics needs. At ProKlin T we relentlessly strive to provide Right Quality and Right Quantity with Right Price at Right Time and Right Place to our clients.



ProKlin T takes pride in its Statistical/SAS Programming Services in Clinical Research and Market Research. Our Team’s expertise and knowledge fueled with passion and integrity toward our work allow us the serve our clients with highest quality. Our loyalty to our clients allows us to realize our success by being a part of our clients’ success.

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