Senior Statistical Programmer

Location: North Carolina, USA
Job Type: Permanent
Specialisation: Life Sciences
Salary: Negotiable
Reference: 78426-PHARM-JCH_1619597445
Contact: Jessica Charles
Email: email Jessica
My client is a full-service CRO with international resources dedicated to helping pharmaceutical and biotechnology companies efficiently and expeditiously navigate the regulatory approval process in order to bring new drugs, biologics, and medical devices to the market.



They're looking for a Senior Statistical Programmer to join their team and provide lead statistical programming support in the project specific programming of CDISC datasets (SDTM, ADaM), analysis outputs (tables, listings, figures), and adhoc reports of all complexities and to provide leadership in project management of trials across several therapeutic areas.



Responsibilities:

Coordinate programming activities for multiple projects across multiple sponsors.
Serve as the statistical programming lead on internal project teams and coordinates programming, verification, and documentation of statistical programs for use in creating datasets, tables, listings, and figures.
Develop and review and ensure compliance of CDISC SDTM and ADaM specifications and datasets.
Generate and review submission documents such as define.xml, SDTM annotated CRF, and reviewers guide.
Contribute to ongoing improvement of programming processes and methodology through evaluation of process steps, tools, and documentation
Provide direct feedback, guidance and work review for junior-level departmental employees to ensure accuracy and adherence to pertinent departmental policies, practices, and procedures.
Programming in SAS and implement SAPs




Qualifications:

B.A./B.S. or equivalent in Statistics, Computer Sciences or related field.
5+ years relevant experience in clinical research. At least two years successfully leading programming activities in clinical research required.
Requires knowledge of drug development principles related to the production of databases and summary tables, such as CDISC standards.