 Sr Statistical programmer
 Sr Statistical programmer
Posted on :
06-06-2025
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1 Vacancy
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Job Description
Responsibilities:
- Creation of SAS programs to Develop or Validate SDTM/Adam/TLFs.
- Provide oversight for CRO SDTM/Adam/TLFs deliverables for multiple studies and make sure efficiencies are gained at project level.
- Generate and/or review of SDTM mapping specifications annotated CRFs Adam specifications documents and reviewers guides per CDISC and FDA specifications and guidelines using standard tools and templates.
- Interact with Biostatistics and Regulatory to design and prepare regulatory submission-ready packages and support responses to health authority information requests.
- Provide technical leadership problem solving of moderate to high complexity and within project timelines while providing high quality deliverables.
- Demonstrate expertise in the SAS language procedures and options commonly used in clinical trial reporting - including the Macro language BASE SAS SAS/STAT and SAS/GRAPH.
- Create all files documents and analyses necessary to support electronic submission(s) in an eCTD format including ISS/Client.
- Accountable for oversight of Statistical Programming deliverables on project level for inhouse and outsourced projects.
- Manage all aspects of Statistical Programming deliverables for multiple studies/projects.
- Support in development and review of global standards templates processes SOPs and Work Instructions.
- Partner with cross functional groups on timelines vendor selection and CRO oversight.
- Expertise in the SAS language procedures and options commonly used in clinical trial reporting including the Macro language BASE SAS SAS/STAT and SAS/GRAPH.
- Experience in development and validation of CDISC SDTM and Adam data models by transforming raw data into standard domains and development and validation of Tables/Listings/Figures.
- Extensive experience of data integration.
- BS or MS in Computer Science or Biostatistics & Life Sciences.
- Minimum of 7 years of industry experience in Statistical Programming to include oversight of CRO deliverables.
- Must possess the ability to work in a team environment.
- Excellent written verbal and interpersonal communication skills.
- Creation of all files documents and analyses necessary to support electronic submission(s) in an eCTD format including ISS/Client.
- Good knowledge of 21CFR11 and GCP.
Employment Type
Full Time
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