Premier Research, a mid-size clinical research and consulting organization, is dedicated to helping biotech, specialty pharma, and device innovators transform life-changing ideas and breakthrough science into new medicines.
Its 1,500 employees, operating in 84 countries across six continents, specialize in the use of innovative technologies for smart study design and trial management to deliver clean, conclusive data to sponsors.
Whether it's developing product lifecycle strategies, reducing clinical development cycle times, securing patient access, navigating global regulations, maximizing the impact of limited rare disease data, or providing expertise in specific therapeutic areas, Premier is committed to helping its customers answer the unmet needs of patients across a broad range of medical conditions.
The Principal 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 Senior Biostatistical Programmer also prepares specifications for data set analysis.
The Principal Biostatistical Programmer acts as Lead Biostatistical Programmer to interact with the Lead Biostatistician and the study team. Additionally, he/she contributes to the tracking of project revenue, backlog, and hours worked on projects, along with forecasting the hours required to complete a project.
The Senior 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
- Acts as Lead Biostatistical Programmer to interact with the Lead Biostatistician and the study team
1. 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
- Develops SAS programs to generate listings without shells
2. 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
- Contributes to the tracking of project revenue and backlog
- Contributes to the tracking of hours worked on projects and forecasts hours to complete
- Participates in efforts for efficiency and productivity in the department
- Performs other work-related duties as assigned
- Participate in corporate initiatives and actions that ensure the continued success of the company
- Attends project and corporate meetings as necessary
- Handles complicated or non-standard sources of data
- Other activities as designated
EDUCATION, SKILLS & COMPETENCIES:
1. Educational Background
- 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
- 10 to 12 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.
3. Expertise and know-how
- 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
- Working knowledge and understanding of advanced statistical concepts to program analysis datasets and tables which include descriptive and standard/complex inferential statistics
4. Personal skills & behaviours
- 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.
- Ability to build client confidence and achieving high levels of customer satisfaction
- Attention to detail and ability to independently work on stand-alone Biostatistical projects with general supervision