Match score not available

Clinical SAS Programmer

Remote: 
Full Remote
Work from: 
Connecticut (USA), Illinois (USA)

Offer summary

Qualifications:

Thorough knowledge of clinical trial study design, Expertise in Adam data standards.

Key responsabilities:

  • Collaborate with team for project deliverables
  • Automate study deliverables using SAS® macros
  • Develop analysis programs and proposal solutions
  • Assist in electronic data submissions to regulatory agencies
  • Contribute to strategic initiatives and audits
Katalyst HealthCares & Life Sciences logo
Katalyst HealthCares & Life Sciences Pharmaceuticals SME https://www.katalysthls.com/
51 - 200 Employees
See more Katalyst HealthCares & Life Sciences offers

Job description

Responsibilities:
  • Works collaboratively with Clinical Development staff to meet project deliverables and timelines for statistical data analysis and reporting.
  • Assesses the quality and consistency of analysis data and performs cross-study analyses.
  • Uses internal macros or writes SAS® macros to automate study deliverables.
  • Works as a primary programmer for multiple Phase 1-4 studies.
  • Assists in submissions of electronic data (e.g., SAS® data sets) to regulatory agencies.
  • Independently develops analysis specification & programs.
  • Identifies potential issues in study documentation and proposes solutions.
  • Contributes to strategic initiatives.
  • Assist with study and systems audits by GSI Compliance Group and external bodies and respond to audit questions and findings.
  • Promote and communicate awareness of programming and the role of the Biometrics department (internal/external; scientific/process)
  • Excellent verbal and written communication skills and interpersonal skills are required.
  • Has thorough knowledge of clinical trial study design and electronic data submission requirements. Must be able to work independently on multiple concurrent projects.
Requirements:
  • Programming standardization activities and departmental initiatives.
  • Collaborate cross-functionally with Macro team and CDMA as needed.
  • Successfully interacts within Clinical Data Science, with Clinical Development and Regulatory Affairs groups on a frequent basis.
  • Expert knowledge of Adam data standards and FDA/PMDA/EMA submission requirements required.
  • Develop, update, and maintain Adam standards.
  • Review and align current Adam Client CORE standards to Regulatory Agency requirements, CDISC TAUGS, and CDISC standards.
  • Review SDTM standards for updates and impacts on current Adam CORE standards.
  • Participate in study specific Adam submission package reviews across multiple authorities.
  • Statistical programmers work collaboratively with internal colleagues and external vendors to ensure the efficient, high-quality production of analysis datasets and statistical outputs for study reports and integrated

Required profile

Experience

Industry :
Pharmaceuticals
Spoken language(s):
English
Check out the description to know which languages are mandatory.

Other Skills

  • Verbal Communication Skills
  • Social Skills

Computer Scientist Related jobs