Principal Statistical Programmer, Hamilton Township

Responsibilities:

Provide input on key study-related documents produced by other functions (e.g. CRFs, Data Management Plan, SAPs, etc.).

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:

Minimum of 6 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 Oncology 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 modelling a plus.

Familiarity with CDISC standards, including SDTM and Adam models. Solid verbal and written communication skills.