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Job Details

Senior Statistical Programmer

Silver Spring, MD

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The Job Details are as follows:
In this role, the selected candidate will develop SAS programs for SDTM, ADaM, project-defined analysis datasets, Tables, Listings and Graphs in support of the Statistical Analysis Plan, posters, manuscripts, Integrated of Summary of Safety (ISS) and Integrated Summary of Efficacy (ISE). Additionally, you will provide technical planning to include overseeing the set-up of key macros and SAS programs; act as a Lead Programmer for projects; represent Statistical Programming at internal and vendor meetings; act as a Statistical Programming lead to internal customers in related disciplines e.g. Clinical Data Management, Project Management and Medical Writing. The position reports to the Director of Biostatistics and Data Management.
Key Responsibilities & Accountabilities:
Complete the statistical programming activities including statistical analysis outputs (tables, listings, and figures), tabulation (SDTM) and analysis (ADaM) data sets per analysis plans and timelines
Demonstrate expert experience with CDISC standards
Prepare the electronic submission materials including data sets, programs, define pdf/xml documents, and reviewer's guides for regulatory submissions
Manage validation process and ensure good programming practices for quality of the statistical deliverables
Conduct quality assurance checks for deliverable of CROs and vendors
Comply with SOPs and working practices in statistical programming area and for the use of computerized systems as they relate to the data management and statistical programming groups
Ensure the implementation of data standardization, eg CDISC, STDM, CDASH, ADaM and data set conversion
Maintain standard data structures, data presentation layouts, and programming tools to improve the quality of the statistical deliverables
Provide expertise of regulatory guidance industry standard practices regarding data structure, data programming, data exchange, and data submissions
Familiarity with global regulatory requirements to support regulatory filings across multinational regulatory agencies
Independently organize, plan, and prioritize workload to meet departmental and project goals and objectives
Review protocols, CRFs, Statistical Analysis Plans
Demonstrate excellent problem solving skills, a proactive approach and a willingness to provide solutions on a regular basis
Produce reports, summaries and listings requested by manager
Effectively communicate business needs to outside vendors and internal vendors
Communicate highly technical issues to non-technically oriented personnel (e.g., drug safety, management, etc.)
Raise, discuss and resolve concerns/issues with relevant internal personnel
Assist, as needed, in validation and UAT of clinical systems
Provide input into outsourcing budget and expenditures
Track and maintain views into operating costs related to statistical programming and computer system / platforms
May review, make recommendations and provide technical leadership regarding proposals from external vendors
Negotiate with vendors and internal finance groups to order equipment
Minimum Requirements:
Bachelor's degree or higher in mathematics, statistics, computing or science related field
5-10 years of computing and statistical programming experience in the pharmaceutical or biotechnology industry
Proven SAS skills within a clinical trials environment
Expertise with CDISC standards
Experiences in managing the successful regulatory submission of the clinical trial data
Strong written and verbal skills
Proficient with SAS (base programming, macro language, SAS/STAT, SAS/GRAPH)
Extensive use of OpenCDISC Validator
Familiar with at least one clinical data management system
Proficient working in a PC/Windows environment
Excellent attention to detail
Strong organizational/time management skills
Strong interpersonal skills
Able to work flexibly across multiple projects and adapt to changing priorities
Able to balance project and non-project activities
Preferred Skills, Knowledge, & Abilities:
SAS certifications a plus
Ability to develop innovative/creative technical solutions to complex problems
United Therapeutics Corporation is an Equal
Action Employer - EOE Minorities / Females / Protected Veterans / Individuals with Disabilities

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