Sr. Clinical Programmer (CRO or Pharma Services)

This project received 5 bids from talented freelancers with an average bid price of $21 USD / hour.

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Project Budget
$2 - $100 USD / hour
Total Bids
Project Description

MMS Holdings Inc., a growing pharmaceutical service organization (CRO), that focuses on regulatory submission support for the pharmaceutical, biotech and medical device industries. We are a pharmaceutical service provider supporting pharmaceutical and biotech industries with medical writing, biostatistics, clinical programming, data management, clinical development, regulatory affairs, regulatory submissions and pharmacovigilance.

Regent's Place

338 Euston Road

London, England NW1 3BT

Please send your resume and mention your current as well as expected salary. Home office can be considered.

Roles & Responsibilities

•Practices good internal and external customer service

•Responsible for implementation and execution of high quality clinical programming

•Demonstrates strong understanding of ICH guidelines, as applicable to clinical programming

•Creates programming training exercises, trains new programmers, and serves as mentor

•Trains via self-study and self-practice independently and explores advanced topics related to clinical programming and/or drug development

•Utilizes System Development Life Cycle (SDLC) for programming deliverables

•Interacts directly and independently with client to coordinate all facets of the project; competent communicator

•Works with statistical personnel to provide definitions, documentation and review of derived variables needed to produce planned tables, listings, and graphs

•Generates tables, listings, and graphs from clinical trial databases using SAS

•Develops programs, verifies, validates, and maintains clinical trial databases and data entry screen using SAS and related software

•Develops data and programming specifications jointly with other programmers and biostatisticians

•Designs specific data presentations including creative summary tables, graphs, and patient listings

•Assists with preparing data validation plan based on client needs

•Reviews data management guidelines for computer edit/validation checks

•Independently implements and validates QC findings in compliance with the NC Handling Procedure

•Conducts thorough self-reviews on own deliverables prior to release to client; acts as high level reviewer for others

•Develops clinical programming efficiencies based on broad, in-depth knowledge of procedures

•Follows processes related to project management as appropriate for programming projects (e.g. updating VeoProject, updating PSS, close-out procedures etc)

•Demonstrates extensive knowledge of departmental processes

Desired Skills & Experience

•Has high level knowledge of drug development as it pertains to clinical programming; has the ability to apply drug development knowledge during production of high quality programs

•Strong hands-on experience with clinical trials and pharmaceutical development

•Strong experience with data and production of TLGs

•Strong programming and logic skills

•Thorough understanding of CDISC standards and HL-7 standards

•Experience in pharmaceutical or CRO industry

•Strong SAS programming, SAS Base, SAS Macro experience

•Thorough knowledge of clinical database structures

•Ability to program data presentations, using program such as SAS procedures

•Strong resource for various programming skills; willing to guide others in a variety of new programming techniques

•Proficiency with MS Office applications

•Excellent organizational and communication skills

•Familiarity with ISO 9001:2008 requirements

Skills Required

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