Statistical Programmer
Silver Spring, MD

Job Description

The Job Details are as follows:

What we do

United Therapeutics is a biotechnology company that focuses on the development and commercialization of unique products to address the unmet medical needs of patients with chronic and life-threatening conditions.

We currently have five approved products on the market and a long-term mission of providing an unlimited supply of transplantable organs for those who need them.

Our company was founded by an entrepreneur whose daughter was diagnosed with a life-threatening condition. She sought to find treatment options and a cure for her daughter and patients like her. We are founder-led, and relentless in our pursuit of "Medicines for Life". We continue to research and develop treatments for cardiovascular and pulmonary diseases, pediatric cancers and other orphan diseases.

How you'll contribute

Overview

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 Accountabilities / Responsibilities

* Complete the statistical programming activities including statistical analysis outputs (tables, listings, and figures), tabulation (SDTM) and analysis (ADaM) data sets per analysis plans, timelines and relevant data 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
* Maintain standard data structures, data presentation layouts, and programming tools to improve the quality of the statistical deliverables
* 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
* Demonstrate excellent problem-solving skills, a proactive approach and a willingness to provide solutions on a regular basis
* Produce data reconciliation reports, summaries and listings requested by manager
* Effectively communicate business needs to outside vendors and internal vendors
* Assist, as needed, invalidation and UAT of clinical systems
* Other duties as assigned

For this role you will need

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 CDISC validation software
* 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

Minimum Requirements

* SAS certifications a plus
* Ability to develop innovative/creative technical solutions to complex problems

Life as a Unitherian

At United Therapeutics, you'll realize quickly that it is not an ordinary place to work! When you join our Company, you will learn, grow, contribute, have fun, and be challenged... all while making a difference in the lives of our patients.

We strive to be an organization that engages the minds, hearts, and most spirited efforts of each of our employees. Our sense of purpose transforms what we do from work into mission, occupation into vocation and achievement into success.

We challenge our employees with innovative and revolutionary projects, offer an environment which fosters high-level of job performance and provides state of the art facilities to flourish. This is what makes United Therapeutics a stimulating place to work.

United Therapeutics Corporation is an Equal Opportunity/Affirmative Action Employer - EOE Minorities / Females / Protected Veterans / Individuals with Disabilities