Principal Statistical Programmer

SUMMARY:

The Principal Statistical Programmer will play a lead role in supporting the statistical analysis and reporting of data from clinical and nonclinical studies.

ESSENTIAL DUTIES AND RESPONSIBILITIES (include, but are not limited to):

Develop and validate statistical programs to support the analysis and reporting of data from clinical and nonclinical studies in support of all corporate therapeutic program areas.

Supervise the activities of junior and contract statistical programmers.

Assist in the development of relevant procedures and processes to ensure that statistical programs are properly documented and validated according to generally recognized industry and regulatory standards.

Participate in the acquisition and installation of department statistical software such as the SAS system.

Develop specifications and SAS programs for the creation of SDTM and ADaM data sets as well as the supporting documentation needed as required by CDISC standards.

Support the preparation of clinical study reports, regulatory submissions, and annual DSUR and safety reports.

QUALIFICATIONS:

Exceptional SAS programming skills and expertise in the development and implementation of statistical programming procedures and processes in a clinical development environment.

Excellent interpersonal skills and problem-solving capabilities with the ability to work independently under minimal supervision.

Demonstrated ability to take a leadership role in all statistical programming activities for a clinical project including supervising the work of junior programmers.

Knowledge of regulatory requirements for dataset submissions (including SAS and CDISC standards) and relevant hands-on experience.

Ability to communicate effectively within a multi-disciplinary project team to assess priorities and complete assigned tasks on time

EDUCATION and/or EXPERIENCE:

Bachelor’s degree or equivalent experience with a computer science, mathematics, or statistics major preferred.  In addition, must have a minimum of five years of experience in the biopharmaceutical (or CRO) industry as a statistical programmer, and must have excellent SAS programming skills and experience programming datasets utilizing CDISC standards.

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