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SAP with SAS at Remote at Remote, Remote, USA
Email: [email protected]
From:

John Richardson,

Themesoft INC

[email protected]

Reply to: [email protected]

Role: SAP with SAS

Remote

Responsibilities

This role involves supporting study teams for Analysis & Reporting of Clinical trial data by taking end to end independent responsibility of assigned projects for all Biostatistics and Analysis & reporting tasks. Senior Statistician ensures the use of appropriate and efficient statistical analysis methods during development, submission and/or life-cycle management products according to applicable global and regional standards, procedures and regulatory guidelines.

Provides statistical and methodological consultation and contributes to multi-disciplinary and multi-company teams.

Provide statistical support for case report form design, database development, data validation plan and blinded data review as and when required.

Support and lead DMC/IA activities as blinded or unblinded Statistician and lead programming team as per requirement

Development of Statistical Analysis Plan (or equivalent) including table shells design.

Perform statistical programming to generate tables, listings, figures, and statistical analysis.

Conduct literature searches to support statistical analysis.

Comply with project / trial standards and specifications following internal guidelines as well as the guidelines set by the various health authorities.

Responds to inquiries from health authorities and other internal or external partners and participate in client or regulatory audits.

Contribute to clinical trial result interpretation and facilitate discussions on the same.

Guide cross functional teams Data management and medical writers for all trial related activities

TOP SKILLS:

1. Statistical Analysis Plan

2. DMC/IA activities

3. Statistical analysis with SAS

Additional Information:

PhD or MS in Biostatistics, Statistics or Mathematics

At least 6+ years of experience as statistician with significant time spent in the Pharma, Biotech, or similar sector

Thorough knowledge of the pharmaceutical or Medical devices industry including understanding of clinical drug development process and associated documents and regulations.

Experience in leading teams

Excellent interpersonal, leadership and communication skills and ability to work independently and collaboratively as required

Good knowledge of statistical programming languages (including SAS)

Fluency in English

Regards,

John Richardson,

Technical Recruiter

Themesoft Inc.,

[email protected]

Keywords: microsoft Iowa
SAP with SAS at Remote
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Tue Aug 13 18:59:00 UTC 2024

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