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Sr. SAS Programmer

unlimited holidays - extra holidays - extra parental leave - long remote period allowed

Remote:

Full Remote

Experience:

Mid-level (2-5 years)

Work from:

Suriname

Offer summary

Qualifications:

Thorough knowledge of clinical trial study design and electronic data submission requirements, Expert knowledge of Adam data standards and FDA/PMDA/EMA submission requirements, Ability to work independently on multiple concurrent projects.

Key responsabilities:

Works collaboratively with Clinical Development staff to meet project deliverables and timelines
Assesses data quality, writes SAS macros, and contributes to strategic initiatives
Develops analysis specification programs, identifies issues and proposes solutions
Assists in submissions of electronic data to regulatory agencies
Promotes programming role awareness within the Biometrics department

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.
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
Participate in study specific Adam submission package reviews across multiple authorities.
Review SDTM standards for updates and impacts on current Adam CORE standards.
Review and align current Adam Client CORE standards to Regulatory Agency requirements, CDISC TAUGS, and CDISC standards.
Develop, update, and maintain Adam standards.
Expert knowledge of Adam data standards and FDA/PMDA/EMA submission requirements required.
Successfully interacts within Clinical Data Science, with Clinical Development and Regulatory Affairs groups on a frequent basis.
Collaborate cross-functionally with Macro team and CDMA as needed.