Key Responsibilities:

• Production of High-Quality Deliverables: Completes and reviews more complex assigned tasks with a focus on accuracy. Conducts all appropriate validation requirements, according to SOPs, for each task undertaken. Checks programming logs for cleanliness and correct processing of data. Inputs into Data Issues log and follows issues to appropriate resolution

Datasets:

• Writes and maintains programming specifications datasets. Programs assigned datasets to industry standards. Handles dataset derivations and assignment
• Tables, Listings and Figures (TLFs):
• Programs TLFs, maximizes programming efficiency with use of biostatistical tools. Checks resulting output for format and content, and questions specification as needed. 

Leadership: 

• Perform as lead programmer on assigned studies. Through this, works closely with the Biostatistical Team Lead and Supervisor, to deliver on time, with high quality and within budget. Tasks include but are not limited to: 
• Develops an efficient programming strategy utilizing available tools and creation/ maintenance of project specific macros, ensures compliance with Good Programming Practice as per SOPs.
• Demonstrates and promotes efficient communication. If in lead role, runs meetings, documenting where necessary and following up on actions. 
• Actively participates in internal project team meetings, providestimely progress updates. 
• As a lead, will have input on estimate at completion (EAC) reporting

Timelines:

• Plans and documents timelines and forecasts resource needs

Project Programming Set Up: 

• Programming project set up and maintenance of BIOSETUP, global tools & project macros
• Programming project set up for integrated databases, with supervision

Statistical Analysis Plan (SAP) and Shells: 

• Performs programming review of SAP and shells, where applicable. Writes programming specifications/shells for safety outputs

Financials: 

• Shares accountability (with resource managers) of the financial success of their studies
• Responsible for sharing budget expectations with their team. 
• Understands ‘scope of work’ and has an awareness of contract and budget assumptions

Knowledge Sharing:

• Helps train staff regarding operational items and mentor’s junior staff

Risk Management: 

• Proposes solutions to mitigate risks.
• Other CDISC requirements: Reviews Pinnacle 21 output and resolves issues. Creates or performs quality control (QC) review of define.xmls, SDTM and/ or ADaM reviewers guide (SDRG, ADRG), under supervision as needed.;
• Perform lead programmer role on studies

Proposals:

• Review and comment on proposals/budgets at a study level
• present at bid defence meetings 

Customer: 

• Serve as primary point of contact for customer and consult on operational topics with clients.

Requirements: 

• Bachelors or Masters’ in Computer Science, Mathematics or equivalent
• 3+ years, statistical programming experience within the Life Science industry 
• Experience as project lead, directly engaging clients and coordinating tasks within a programming team
• Knowledge of applicable clinical research regulatory requirements, i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines
• Knowledge of Base SAS, SAS/STAT, SAS Graph and SAS Macro Language
• Ability to independently lead multiple tasks and projects