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Senior Statistical Programmer

unlimited holidays - extra holidays - extra parental leave - long remote period allowed
Remote: 
Full Remote
Experience: 
Senior (5-10 years)
Work from: 

Offer summary

Qualifications:

BS/BA degree in related discipline, At least 5 years of statistical programming experience with clinical data and SAS, Experience in oncology therapeutic area preferred, Strong SAS programming skills, CDISC proficiency required.

Key responsabilities:

  • Develop and maintain SAS programs for data review and reporting
  • Create Data Listing Reports and develop patient profiles
  • Participate in data transfer specifications and processing
  • Oversee development of CDISC-compliant datasets by CROs
  • Verify programmers' results and troubleshoot technical issues
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:
  • Programs SAS Non-System Edit Checks, Protocol Deviations and SAS Data Listings
  • Ability to independently develop innovative and complex SAS programs to support activities including, but not limited to, data review and reporting, and development of patient profiles.
  • Supports the maintenance of the Non-System Edit Check Global Library to ensure consistency across programs and studies and concordance with the EDC Global Library
  • Create SAS program Specifications for Non-System Edit Checks based on CRF and non-CRF data.
  • Responsible for participating in the development and review of data transfer specifications, processing of clinical data downloads, and data transfers to/from service providers.
  • Create Clinical Data Review Tools [i.e., Data Listing Reports (DLRs); External Data Reconciliation Listings, Medical Safety Listings for reconciliation, etc.] for all studies based on study-specific specs and requirements.
  • May oversee development of datasets (SDTMs/ADaMs) in CDISC-compliant format by CROs including clear documentation of the process that was followed in the form of specifications, trackers, and checklists.
  • May be involved in QC of CRO deliverables like ADaMs, and tables, listings and figures.
  • Independently develop SAS or other programs and specifications for the production of output to support study needs including publications, safety reporting, and ad hoc analyses in a timely fashion
  • Independently verify other programmers' results
  • Develop and/or validate standard macros to automate output production.
  • Adhere to company SOPs and department guidelines.
  • Work concurrently on multiple projects
  • Troubleshoot technical and project issues.
  • Help with infrastructure development of the department.
  • Communicate effectively with internal cross-functional groups and external partners.

Requirements:

  • BS/BA degree in related discipline
  • At least 5 years of experience in statistical programming with clinical data and SAS
  • Experience in oncology therapeutic area strongly preferred.
  • Strong SAS programming skills required with proficiency in SAS/Base, SAS/Stat and SAS/Macros
  • CDISC proficiency required.
  • SAS/GRAPH experience desirable.
  • Knowledge of appropriate regulations, industry standards and guidance documents
  • Uses broad expertise or unique knowledge and skills to contribute to development of company objectives and principles, and to achieve goals in creative and effective ways.
  • Good interpersonal communication skills to collaborate effectively with internal cross-functional groups and external partners.


Required profile

Experience

Level of experience: Senior (5-10 years)
Industry :
Pharmaceuticals
Spoken language(s):
English
Check out the description to know which languages are mandatory.

Other Skills

  • Collaboration

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