Description
We are seeking a Statistical Programmer to develop statistical methods sections of protocols and review case report forms (CRFs). You will prepare analysis plans and write specifications for analysis files, tables, and figures. You will communicate with clients regarding study protocol or statistical analysis issues as they arise and collaborate with study team members to ensure timely and high-quality deliverables.
Responsibilities
- Develop statistical methods sections of protocols and review CRFs
- Prepare analysis plans and write specifications for analysis files, tables, and figures
- Communicate with clients regarding study protocol or statistical analysis issues
- Collaborate with study team members to ensure timely and high-quality deliverables
- Interpret analyses and write statistical sections of study reports
- Control costs and maximize revenue recognition
- Provide training, guidance, and mentorship to lower-level and new staff
Leadership Responsibilities
- Perform statistical team lead role on single studies
- Work closely with Project Team Lead and supervisor to deliver on time, with high quality and within budget
- Build and maintain effective customer relationships
- Demonstrate and promote efficient communication
Data Management
- Assist in reviewing or advising data management staff on database design, validation checks, and critical data
- Handle data issue resolutions
- Manage lock and unblinding process with appropriate supervision
Statistical Analysis Plan (SAP) and Shells
- Author or perform quality control review (QC) of SAPs and shells
- Make best use of resources and expertise within the organization
Datasets
- Write and maintain programming specifications
- Program assigned datasets to industry standards
Tables, Listings, and Figures (TLFs)
- Write programming specifications for statistical analyses outputs
- Program TLFs, maximizing programming efficiency with use of tools
Timelines
- Plan and document timelines, forecast resource needs, and suggest work may be out of scope
Financials
- Share accountability for the financial success of assigned studies
- Control costs and maximize revenue recognition
Knowledge Sharing
- Help train staff regarding operational items
- Mentor junior staff
Risk Management
- Identify risks to project delivery and/or quality and propose solutions to mitigate risks
Requirements
- Bachelor's Degree in Biostatistics or related field and 3-5 years relevant experience
- Master's Degree in Biostatistics or related field and 3-5 years relevant experience
- Ph.D. in Biostatistics or related field and 1 year relevant experience
- Advanced knowledge of job area and broad knowledge of other related job areas
- Excellent written and oral communication skills
- Strong individual initiative and organizing skills
- Strong working knowledge of SAS computing package
- Familiarity with other relevant statistical computing packages such as nQuery
- Strong commitment to quality