Principal Statistical Programmer (AD Level)

Proclinical is currently recruiting for a Principal Statistical Programmer with a global pharmaceutical company located in Raleigh, NC. Successful candidate will effectively lead the project programming team and influence key stakeholders ensuring upward communication of major issues and learnings to Global Head of Programming and SSI leadership team.

Job Responsibilities:

• Foster and encourage a culture of innovation, and act as a role model to others in actively owning and sharing the use of innovative methods throughout the statistical programming department.
• Provide oversight and strategic direction of programming activities within the project team, ensuring commitment to quality standards and processes and efficient delivery.
• Develop close collaboration with the project statistical leads where relevant and identify key areas in which to establish joint initiatives and information sharing aligned with our Patient Value Strategy.
• Contribute to the development of the internal profile of the SSI practice developing the group as a partner of choice.
• Represent and enhance the external profile of UCB's Programmers, through involvement in external industry bodies such as PSI, PhUSE, CDISC, etc.
• Lead and manage programming deliverables of a project, utilising comprehensive knowledge of programming standards (e.g. ADaM, CDISC etc and including innovative approaches), and knowledge of regulatory and post marketing requirements, working with the statistical project leads and specialist SSI groups as appropriate.
• Engage cross functionally to provide expert input into collaboration projects such as publications, clinical reports and patient safety.
• Lead and manage both internal programming teams and major vendor partners
• Line manage permanent programming staff within the project team(s) providing technical support, career progression advice and training and enabling mentorship as necessary
• Collaborate with other Project Programming Leads to discuss resource requirements and staff development plans which impact the practice workforce planning. Report progress on practice clinical program planning to Global Head Programming. Subject matter expert for project management software (e.g. Integrate), supporting successful entry and management of SSI project codes.

Skills and Requirements:

• BS in Statistics, Mathematical, Statistical Computer Science or Life Science, or comparable required, MSc preferred.
• Extensive experience of working within the Pharmaceutical industry.
• Experience of managing global teams & projects.
• Experience of line managing programmers strongly preferred.
• Extensive SAS and/or R programming knowledge, ideally to expert level.
• Extensive knowledge of the drug development program across all phases of clinical studies.
• Extensive knowledge of the regulatory submission requirements for datasets.
• Proven influencer and collaborator in a project team environment.
• Previous experience in a Project Lead Programming type role, ideally in a Pharma or CRO environment.
• Knowledge of SDTM/ADaM CDISC standards.
• Experience in core submission pre-requisites.
• Knowledge of analysis and reporting of clinical trials.
• Computer/software proficiency supporting data analysis, including familiarity with software such as NONMEM, PKS. S+, BUGS or JMP in order to work in partnership with IT.

To Apply:

Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.

In case you have difficulty in applying or if you have any questions, please call Felix Hook at (+1) 646-367-2617 or upload your resume on our website - www.proclinical.com.

A full job description is available on request.

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Proclinical Staffing is an equal opportunity employer.

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