Principal Statistical Programmer - Basking Ridge, United States - Katalyst HealthCares & Life Sciences

Katalyst HealthCares & Life Sciences Basking Ridge, United States

2 weeks ago

Description

Responsibilities:
Lead statistical programming activities as product lead for full development project or groups of projects in Oncology Therapeutics.

Attending multi-disciplinary team meetings, representing the statistical programming function.

Create or review and approve statistical programming plans at study and project level.

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.

Participate and/or lead in the development and implementation of SAS programming standards, SOPs and work instructions, including program validation and documentation.

Develop and validate programs (SAS or R) to generate displays of clinical study data as tables, listings, and graphs for electronic submission to regulatory agencies.

Requirements:
Minimum of 5 years of experience in developing statistical programming deliverables 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.

Ability to manage multiple complex projects and assess resource needs.

Excellent verbal and written communication within the Biostatistics group and across other functional areas.

Significant experience in developing SDTM, ADaM and TFLs using SAS or other tools.

Expertise with CDISC standards.

Good understanding of clinical standards as well as clinical data sets from major EDC systems (e.g., Medidata Rave, INFORM), safety systems (Argus), and CTMS systems.

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