Senior Biostatistical Programmer
Premier Research helps highly innovative biotech and specialty pharma companies transform life-changing ideas into reality, targeting unmet needs in analgesia, neuroscience, oncology, pediatrics, and rare diseases.
We’re looking for an exceptional Senior Biostatistical Programmer home of office based in Darmstadt, Germany to bring your passion to our team. You will be encouraged to grow professionally and personally while enjoying cross-functional partnerships with genuinely supportive colleagues, regardless of location or seniority. Most importantly, you will be using your skills to bring tangible hope to critically ill patients around the world.
At Premier Research, we are science-minded and heart-centered. Join us.
The Senior 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 CDISC datasets. The Senior Biostatistical Programmer acts as a 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 task or project.
The Senior Biostatistical Programmer:
- Develops SAS programs to generate listings, tables and graphs as outlined by TLF shells
- Performs QC (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
- Develops SAS programs to generate tables and listings without shells
- Acts as Lead Biostatistical Programmer to interact with the Lead Biostatistician and the study team
- Contributes to the tracking of project revenue and backlog
- Contributes to the tracking of hours worked on projects and forecasts hours to complete
- Develops listing shells for SAP
- Writes ADaM specs for safety domains
- Develop and maintain overall awareness in the field of biostatistical programming by attending training classes, professional meetings, following-up on technical developments, etc.
- Keep detailed records of time spent on each project to allow accurate billing
- Respect and maintain the confidentiality of the processed material and ensure that any regulations concerning security or confidentiality (such as the safeguarding of passwords) are complied with
- Attend project team meetings as required
- Review and provide feedback on data management documents
- Perform other work-related duties as assigned
- BS or equivalent from accredited college or university, in statistics, IT, mathematics or closely related field.
- 4-7 years experience in SAS programming within the area of clinical trials.
- 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.
- Strong computer skills, with evidence of advanced SAS programming skills.
- Excellent English Communication skills (verbal, written & interpersonal).
- Detail oriented, well organized.
- Ability to work in fast paced environment
- Ability to act on their own initiative
- Consistently provides high touch customer service both internally and externally
- Ability to be productive and handle multiple tasks to meet deadlines in a dynamic environment.
- Ability to build client confidence and achieving high levels of customer satisfaction.
- Attention to detail and ability to independently work on standalone Biostatistical projects with general supervision.