Statistical Programmer II

The Statistical Programmer II will provide programming support for the development and validation of programs that create datasets conforming to Alexion and CDISC standards, as well as Tables, Listings, and Figures (TLFs) for analysis purposes. This role will develop specifications to ensure that statistical programming elements align with the overall deliverable and adhere to ICH guidelines, Good Clinical Practices, and regulatory requirements. The Statistical Programmer II must demonstrate an ability to understand statistical concepts with SAS Programming efficiently and effectively. This role is primarily responsible for providing support to deliver technical programming and information components of moderate scope and medium complexity studies or drug projects. It will act as a contributor on cross-functional teams to deliver continuous improvement, working under the general direction and support of an experienced programmer.

Accountabilities

• Under guidance, support development of technical programming specifications for SDTM, ADS, or ADaM standards
• Develop and/or validate programs that generate SDTM datasets, analysis datasets based on Alexion or ADaM specifications, and tables, listings, figures/graphs based on Protocol and SAP
• Understand the contents of protocols and clinical development plans to understand the contribution of their work
• Work within established frameworks and ensure high quality is built into own deliverables
• Work independently for well-defined scope of work
• Continue to acquire knowledge of the drug development process
• Continue to increase knowledge of SAS
• Continue to increase knowledge of industry standards
• Take steps to understand the roles and skills of others in clinical study teams
• Take steps to understand the roles and skills of other functions in drug development
• Proactively keep the lead programmer updated on progress of deliveries
• Collaborate with external vendors and contract programmers
• Provide project progress updates of programming activities
• Support project leadership ensuring that department standards are implemented in all studies
• Contribute ideas and thoughts towards the optimization of standard operating procedures
• Any other activities as required

The duties of this role are generally conducted in an office environment. As is typical of an office-based role, employees must be able, with or without accommodation, to: use a computer; engage in communications via phone, video, and electronic messaging; problem solve; engage in complex and non-linear thought, analysis, and dialogue; collaborate with others; maintain general availability during standard business hours.

Minimum Requirements

• 2 to 4 years of statistical programming experience in the Pharmaceutical, Biotechnology, or Contract Research Industry.
• Ability to:
• Understand the concepts of development and validation of technical specifications and programs for safety and efficacy analysis datasets, tables, listings, and figures/graphs.
• Work collaboratively to resolve problems
• Clearly communicate with management and team members
• Understanding and basic competence in using SAS/Base, SAS/Macro, SAS/STAT, or other statistical computing software.
• Basic understanding of relational databases and good programming practices.