The Biostatistical Programmer is responsible for the production of project-related datasets, tables, listings, and figures (TLFs) required for delivery to Premier Research Sponsors. This individual also performs Biostatistical programming quality control and validation to support global Biostatistics projects. This work is completed through the development and validation of SAS software programs, macros, and utility tools. The Biostatistical Programmer also prepares specifications for data set analysis.
The Biostatistical Programmer:
Develops SAS programs to generate listings, tables and figures as outlined by mock TLF shells
Performs quality control (source code review, double-programming and log review) of SAS programs
Develops SAS programs to generate CDISC and other analysis data sets as outlined by respective specifications
Prepares specifications for CDISC and other analysis data sets
Assists Data Management with SAS programming needs
For project success:
Keeps detailed records of time spent on each project for accurate billing
Respects and maintains the confidentiality of the processed material and ensure that any regulations concerning security or confidentiality (such as the safeguarding of passwords) are complied with
For commercial success:
Develops and maintains overall awareness in the field of Biostatistical programming by attending training classes, professional meetings, following-up on technical developments, etc.
Ensures that work is completed on time and at the correct level of quality
Participates in efforts for efficiency and productivity in the department
Participate in corporate initiatives and actions that ensure the continued success of the company
Attend project and corporate meetings, as necessary
Other activities as designated
BS or equivalent from accredited college or university, in statistics, IT, mathematics or closely related field or work related experience to be able to perform this role
2-4 years of experience in SAS programming within the area of clinical trials.
Prior experience using computerized information systems preferred.
Knowledge of ICH and local regulatory authority drug research and development regulations preferred.
Proficiency in Microsoft Word, Excel, PowerPoint, and Outlook
Demonstrated working knowledge of data processing, database design and organization in clinical data environment
Demonstrated working knowledge of basic clinical trial design and analysis principles
Working knowledge of CDISC standards and application of these standards to projects
Fluent verbal and written English as well as the local language(s) required for clinical trial submissions.
Excellent team player, collaborative and able to build an effective team.
Ability to multitask and work effectively in a fast-paced environment with changing priorities.
Strong verbal and written communication and negotiation skills.
Excellent organizational and time-management skills, able prioritize work to meet deadlines.
Accountable, dependable and strong commitment.
Is customer service focused in approach to work both internally and externally.
Maintains a positive, results orientated work environment.