Description
PRIMARY RESPONSIBILITIES:This lead Statistician/SAS Programmer will be responsible for creating SAS programs in support of BNIT clinical trials according to SOPs and guidelines. This lead will create, document, validate, process, and maintain statistical programs and macros that generate analysis datasets, tables and graphics with high quality per agreed timelines. This lead will also be responsible for hands-on support in statistics and programming for the Clinical Development Group.
Responsibilities
- Act as lead Statistician/ programmer write SAS programs that produce analysis datasets and analyses specified in the Statistical Analysis Plan
- Act as quality control programmer to validate SAS programs that produce analysis datasets and analyses specified in the Statistical Analysis Plan
- Overseeing the daily tasks associated with clinical programming and subsequent analysis to ensure deliverables are created per agreed timelines and to high quality standards
- Participate in SOP creation, review, and maintenance as needed
- Experience with data visualization tools (e.g., JMP, Spotfire etc.)
- Ensure programs adhere to SOPs, guidelines, and specifications
- Ensure SAS program output matches the requirements of the Statistical Analysis Plan
- Consult with Clinical Development, Data Management and Safety personnel to clarify program intent, identify problems, and suggest changes
- Design and/or review database structure
- Create derived-analysis datasets
- Execute analyses specified in the Statistical Analysis Plan (SAP) or Data Safety Monitoring Board (DSMB) Charter under the guidance of the vendor statistician(s)
- Take instructions and perform tasks as necessary as directed by reporting manager
- Ensure specifications and documentation are correct and complete
- Work with other team members to ensure outputs are correct and complete
- Organize, plan, and prioritize work to develop specific goals and plans to prioritize, organize, and accomplish project objectives
- Analyze information and evaluate results to choose the best solution and solve problems
- Develop, maintain, and produce TLFs
- Create, use, modify, and maintain all SAS program code
- Create and maintain file structures for storing clinical data
- Assist in the preparation of regulatory submission-ready packages
- Conduct programming and corresponding documentation for regulatory submissions
- Assist in reviewing DMP, CRF/eCRF design and other clinical data documents
- Assist in reviewing SAP and other related documents
- Partner effectively with multiple CROs to perform any of the above tasks
- Provide high quality SAS output for ad hoc queries as requested by internal clinical staff
Knowledge, Skill and Competency Requirements:
- Extensive knowledge of creating SAPs as well as Base SAS, SAS/GRAPH, SAS/STAT, SAS Macro, SAS/SQL
- Thorough knowledge of applied statistical methodologies
- Experience in constructing technical programming specifications and producing validated SAS programs
- Experience working with heterogeneous data structures
- Experience with electronic data capture systems, Oracle/Clinical preferred
- Ability to work independently and adept at managing multiple competing tasks
- Good understanding of clinical data and pharmaceutical development
- Experience in working with CDISC standards including SDTM and ADaM
- Knowledge of clinical trial conduct and the data and reporting requirements for clinical trials
- Knowledge of SAS programming techniques needed to produce outputs in accordance with appropriate specifications
- Familiarity with immunotherapeutic products and oncology trials a plus
- NDA experience, including ISS/ISE
- Experience working with CROs and other outside vendors providing data, and developing strong sponsor/vendor relationships]
- Excellent written, verbal, and interpersonal communication skills in cross-functional teams
- Strong organizational and analytical skills
To find out more about Real please visit www.realstaffing.com