Statistical Programmer II

Statistics and Data Corporation

- Telecommute

SDC is a collection of diversified professionals who are committed to providing experienced teams who will take ownership of client needs and are positively engaged in projects. We provide top-tier clinical trial services to pharmaceutical, biotechnology, and medical device/diagnostic companies since 2005. Our global team operates in the highest quality of ethics and sustainability by adopting our clients’ needs as our own and delivering exceptional results. We view ourselves as a valued partners to our clients and our proven track record of success has allowed us to grow year over year.

Our commitment to our clients is the same commitment to our employees. By offering strong benefits, focused career development, and a flexible schedule we can attract and employ some of the most talented people in the industry. Energy, Integrity, Engagement, Innovation, Ownership, and Commitment are our core values and the backbone of our culture at SDC.

Take a look at how you can join our team!

About the role:

Provide statistical programming support to clinical trials. Produce statistical analyses, including generating/validating analysis datasets, tables, listings, and figures for clinical trials.

Primary Responsibilities

  • Perform assigned statistical programming required for clinical trial analysis and reporting
  • Work under the direction of senior statistical programmers in completing clinical trial programming tasks• Review the Statistical Analysis Plan in preparation for programming analyses
  • Apply appropriate statistical methods for data analysis
  • Assist in designing/developing SAS macros and other utilities to expedite SAS programming activities
  • Generate tables, listings, and figures per protocol, Statistical Analysis Plan, and/or approved client request
  • Participate in statistical program validation and quality control activities, as assigned
  • Assist in development of SDTM aCRF and specifications; complete programming and validation of CDISCSDTM and ADaM datasets
  • Develop define.xml and create table of contents of programs for regulatory submissions
  • Interact with other departments, such as Clinical Operations, Project Management, and Data Management toensure a high level of client satisfaction through successful execution of projects
  • Program data cleaning checks, as necessary, to facilitate Data Management's data cleaning activities
  • Timely completion of assigned tasks within budgeted hours
  • Utilize the Infrastructure for project files of SAS datasets and SAS code
  • Ensure all programming activities and processes performed are conducted according to SDC's standardprocedures and/or sponsor requirements
  • Adhere to all aspects of the SDC's quality system
  • Comply with SDC's data integrity & business ethics requirements
  • Perform other related duties incidental to the work described herein
  • Adherence to all essential systems and processes that are required at SDC to maintain compliance tobusiness and regulatory requirements
  • The above statements describe the general nature and level of work being performed by individuals assigned tothis classification. This document is not intended to be an exhaustive list of all responsibilities and duties requiredof personnel so classified.

Requirements

  • Sound analytical skills, with the ability to process scientific and medical data
  • Proficient SAS programming skills required, with expert knowledge in SAS/Base, working knowledge inSAS/Stat and SAS Macros.
  • Basic understanding of SAS/Graph
  • Experienced In manipulating and analyzing SAS data
  • Ability to identify data issues, present problems, and implement solutions
  • Problem-solving skills
  • Able to work with minimal supervision
  • Good organizational and time management skills
  • Familiarity with clinical trial design and analysis activities and basic knowledge of regulatory guidelines(FDA/CFR, ICH/GCP)
  • Strong interpersonal communication and presentation skills
  • BASE SAS and Advance SAS Certification or equivalent experience is preferred

Education or Equivalent Experience

  • Bachelor's degree in computer science, statistics or other related, scientific field and two to four years ofrelevant professional experience; or an equivalent combination of relevant education and/or experience.
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