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Contract : : Senior/Principal Statistical Programmer : : Remote at Remote, Remote, USA
Email: [email protected]
Good morning !! 

DKMRBH Inc. is currently seeking a

Senior/Principal Statistical Programmer for one of our premium clients. If you are interested to know more, please share an updated copy of the resume and best time to connect.

Type

6+ months contract

Location

Remote

NOTE
: 
The
client is

not sponsoring the visas this time.

Job Description:-

QUALIFICATIONS & REQUIREMENTS:

10-15+ years of statistical programming experience in the pharma/biotech industries working for Sponsor companies

Must be able to independently develop SDTM and ADaM specifications (DDT) and program, develop and validate TFLs

Must have worked on a submission within the last year or two

Define package experience and ISS/ISE experience

Experience leading and managing statistical programming activities for clinical trials and regulatory submissions

Strong experience with regulatory submissions activities

DUTIES & RESPONSIBILITIES:

Support statistical programming activities for clinical studies, ensure statistical programming deliverables are delivered within timelines

Maintain statistical programming standards, processes, and SOPs

Manage CRO and review deliverables for accuracy and compliance, performing perform acceptance check and validation

Manage, review, and/or execute statistical programming deliverables for planned statistical analysis related to study monitoring, clinical study reports, data integrations,
and regulatory query responses, covering multiple studies

Generate TFLs to support ad hoc requests

Review data management documents (CRF specification, data transfer agreements, DMP, annotated CRF), SDTM and ADaM specification, SAP, and TFL shells to provide statistical
programming feedback

Thanks & Regards,

Varchasva Sharma
 / Technical Recruiter

Email: 

[email protected]

Connect
@ Linkedin

DKMRBH Inc.

1201 N Orange ST, Suite#7284, Wilmington DE 19801

Web: 

http://dkmrbh.com/

DKMRBH
Inc. @ Linkedin

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Wed Aug 23 23:32:00 UTC 2023

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