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Urgent Need Statistical Programmer -->100% remote || needed 10-12 year of exp at Remote, Remote, USA
Email: [email protected]
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From:

vinay,

vyze

[email protected]

Reply to: [email protected]

Job Title- Sr Statistical Programmer

Location - Remote ( united States )

Duration - 6 Months

Start: ASAP

Only Stats Programmers or Biostatisticians but they have to have 10-12 plus years of experience in the US and verifiable references we can check on LinkedIn or Zoom Info.

A pharmaceutical company in California needs a hands-on Sr Statistical Programmer for a 6-month project. This client has a short-term pain study that will be kicking off early 2024. They need a strong statistical programmer to join the team as the Independent Reviewer, helping to take work off the statisticians plates.

This consultant must be comfortable working in a small-team setting as one of the only programmers (i.e., flexible with a limited amount of SOPs, understand small-group/small company dynamics). This project will extend should the study elicit positive results, and if it is a success this consultant will help put together the ISS and data package preparation, define.xml, data review guides, tabular datasets, etc.

QUALIFICATIONS & REQUIREMENTS :At least 12+ years of Statistical
Programming experience in the pharmaceutical industry

Expertise in CDISC SDTM implementation (at least 3+ years); ADaM implementation is a plus

Experience with questionnaires (pain ideally), clinical outcomes (cancer & tumors preferred), epro

Experience with ISS and data package preparation, define.xml, data review guides, tabular datasets, etc

Must be able to understand domains and read the Progress Report

RESPONSIBILITIES:

Act as IR for the data team and as primary in-house programmer assisting statisticians with development activities

Developing and validating SAS programs to produce high quality deliverables following specifications, including CDISC SDTM modelled tabulation data sets (TD), ADaM modelled analysis data sets (AD) in compliance with company and regulatory requirements.

Perform conformance checking of CDISC modelled TD and AD using Pinnacle 21s OpenCDISC Community tool and applicable regulatory agency data standards requirements to ensure data sets follow submission standards

Put together data packages for FDA

LOCATION:

Work will be performed remotely. Pacific zone working hours must be accommodated.

Best Regards

Vinay kumar singh

Technical Recruiter | VYZE INC.

25179 Methley Plum Place, Aldie, VA 20105

Email:

[email protected]

Keywords: active directory information technology Virginia
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09:27 PM 21-Nov-23


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