What are the responsibilities and job description for the Senior Biostat Programmer position at Zenith LifeScience?
Senior Biostat Programmer (Statistical programmer)
Location: Nutley, NJ
Duration: 12 Months
Job Duties
Qualifications and education required
Location: Nutley, NJ
Duration: 12 Months
Job Duties
- Expert in addressing technical challenges that connect SAS, CDISC and XML.
- Excellent technical skills in SAS system and application development.
- Proven experience in development and implementation of clinical standards in a global pharmaceutical environment.
- Expert in integrating SAS with other leading technologies such as PDF, XML, Microsoft Office, to support electronic submissions.
- Experience in consulting projects dealing with the assessment, design and/or implementation of CDISC data standards in the clinical data life cycle.
- Annotate CRFs in accordance with CDISC published or company specific guidelines with appropriate metadata to reflect case report tabulation data sets.
- Review and quality assure CRF annotations produced by other programmers
- Embrace and contribute to our culture of process improvements with a focus on streamlining our processes adding value to our business needs.
- Review and quality assure data set and programming specifications produced by other programmers.
- Accountable for development and maintenance of cross-functional / cross-department process related to clinical trials SDTM data production, including specification, programming, QC, and deliverables of SDTM data for analysis and submission.
- Accountable for execution of process related to clinical trials SDTM data production, including specification, programming, QC, and deliverables of SDTM data for analysis and submission
- Engages appropriate stakeholders in communication to create SDTM standards and process for transition of clinical data to SDTM
- Accountable for SDTM datasets specification, conversion, and delivery to stakeholders, specifically Statistical Programming, but also other users of SDTM datasets, with high quality and on time.
- Provides SDTM data production technology to CDO (Clinical Data Operations) related to SDTM data delivery and manages the activities of a team with a common focus
Qualifications and education required
- Masters Degree in Computer Science or Mathematics or any relevant field.
- Minimum 12 years of relevant programming and application development experience in CRO, Pharmaceutical or Biotech organizations.
