Principal Statistical Programmer

3 weeks ago

Cary, United States CareerBuilder Full time

Responsibilities:

Create or review and approve CDISC-compliant datasets and corresponding documentation for electronic submission to regulatory agencies.

Develop software systems to generate displays of clinical study data as tables, listings, and graphs for electronic submission to regulatory agencies

Assist statisticians by suggesting algorithms to address Client analysis requests

Develop software validation procedures and test plans, as necessary.

Create and document archives of software, outputs, and analysis files.

Create and maintain department SOPs related to clinical programming.

Review draft clinical reports, journal articles, slide presentations, and other documents to assure that results are reported accurately.

Oversee work of internal contract programmers and external vendors.

Provide time and resource estimates for project planning.

Requirements:

Bachelor's degree in computer science, Statistics, Mathematics, Life Sciences or other relevant scientific fields; master's degree preferred

Minimum of 3 years of experience in developing software for clinical trials using the SAS system

Skilled in programming with SAS. Knowledge of additional programming languages a plus.

Good knowledge of statistics and drug development process

Experience as a lead programmer for NDAs/BLAs

Experience overseeing the work of internal contractors and external vendors (CROs)

Experience in pharmacokinetics/pharmacodynamics modeling a plus

Familiarity with CDISC standards, including SDTM and ADaM models

Solid verbal and written communication skills

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