Senior STDM Programmer
Performs statistical analysis on data related to product development in a research and development environment. Uses statistical software (SAS, R, etc) to create and maintain listings, tabulations, graphical summaries, and formal statistical estimates and tests. Creates datasets in a standard format (i.e., SDTM), analysis datasets, assesses quality of data analysis programs, and develops automated analysis tools where appropriate. Develops programs to assist with data review such as edit checks and custom listings. May be responsible for data integration used for clinical summaries and/or creation and quality control of statistical submission components to regulatory agencies. May partner with biostatisticians and clinical data management staff in establishing standards for clinical data collection, management and/or reporting of data.
ESSENTIAL DUTIES AND RESPONSIBILITIES
• Independently develop SAS or other programs, and specifications, for use in study or other analyses, such as Integrated Safety Summaries.
• As the lead programmer for a study, works with clinical data management staff and biostatisticians to coordinate and schedule data transfers and the delivery of required outputs. Responsible for helping to identify when additional programming resources are needed for a project, communicating with their supervisor to arrange for those resources, and coordinating and overseeing other statistical programmers’ work on the project as needed.
• Oversees the development of datasets in SDTM format by CROs, including clear documentation of the process that was followed in the form of specifications, trackers, and checklists.
• Responsible for programming QC oversight of CRO deliverables such as analysis datasets and tables, listings, and figures (TLFs).
• Must be able to program defensively, check results, and consistently produce accurate output.
• Independently verify other programmer’s results.
• Adhere to FDA regulations regarding training records, guidelines, and SOPs.
• Adhere to company SOPs and department guidelines.
• Produce study datasets and programs that will help meet CDISC standards.
• Support Ad-hoc requests as needed.
• Work on multiple tasks at the same time and prioritize tasks to meet business needs.
• Trouble-shoot technical and project issues.
• Help with the infrastructure development of the department.
• Assist team to ensure timelines for the study and/or project are met.
• Assist with training new employees and contractors, in particular on study specifics and departmental programming conventions and standards.
• Communicate with outside departments and/or groups.
• Meet timelines on a regular basis.
• BS/BA degree in related discipline and eight years of related experience; or,
• MS/MA degree in related discipline and six years of related experience; or,
• PhD in related discipline and four years of related experience, or;
• Equivalent combination of education and experience.
• May require certification in assigned area.
• At least 6 years experience in statistical programming with clinical data and SAS.
• Strong SAS programming skills required, with proficiency in SAS/Base, SAS/Stat and SAS Macros.
• UNIX, S-Plus, R, CDISC, and SAS/GRAPH experience desirable.
• Ability to communicate verbally and in writing in a clear and timely manner.
• Experience in Biotech/Pharmaceutical industry preferred.
• Has extensive experience in relevant industry/profession and area of specialization.
• Uses professional concepts and company objectives to resolve complex issues in creative and effective ways.
• Identifies and implements methods and procedures to achieve results.
• Leads or manages the work of others by providing guidance to subordinates or teams based on organizational goals and company policy, with responsibility for results, including costs, methods and staffing.
• Performs a variety of complicated tasks with a wide degree of creativity and latitude.
• Has complete understanding and wide application of technical principles, theories, concepts and techniques.
• Has good general knowledge of other related disciplines.
• Applies strong analytical and business communication skills.
• Works on complex problems where analysis of situations or data requires an in-depth evaluation of various factors.
• Exercises judgment within broadly defined practices and policies in selecting methods, techniques and evaluation of criteria for obtaining results.
• Uses professional concepts and company’s policies and procedures to solve a wide range of difficult problems in imaginative and practical ways.
• Networks with key contacts outside own area of expertise.