Premier Research is looking for a Director, Biostatistical Programming to join our Biostatistics team.
You will help biotech, medtech, and specialty pharma companies transform life-changing ideas and breakthrough science into new medicines, devices, and diagnostics. What we do is profoundly connected to saving and improving lives, and we recognize our team members are the most valuable asset in delivering success.
- We are Built for You. We are here to help you grow, to give you the skills and opportunities to excel at work with the flexibility and balance your life requires.
- We are Built by You. Your ideas influence the way we work, and your voice matters here.
- We are Built with You. As an essential part of our team, you help us deliver the medical innovation that patients are desperate for.
Together, we are Built for Biotech™.
Join us and build your future here.
What You'll Be Doing
- The Director, Biostatistical Programming serves as core team member and leader for larger projects. This position is responsible for Biostatistical Programming operations, directing project assignments, and the overall activities of project team personnel. The Director also reviews departmental deliverables for accuracy, completeness, and compliance with project specifications to ensure quality deliverables to Sponsors. The Director is responsible for both management and technical aspects of development projects. As a technical expert, this individual provides strategic guidance to development projects. When functioning in a supervisory role, the Director provides coaching guidance to more junior staff and line management to the team, while overseeing the technical evolution of the departmental work product.
- Supervises, mentors, and motivates reporting associates in tasks and activities in order to develop and maintain the team structure
- Provides support for the maintenance and management of the biostatistics macro library
- Prepares specifications for CDISC and other analysis data sets
- Performs QC (source code review, double-programming and log review) of SAS programs
- Participates in and contributes to the training and development of new Biostatistical Programmers
- Lead efforts in the development, maintenance and adherence to departmental SOPs and guidelines
- Keeps up on CDISC and other industry standards and ensures dept is kept up to date
- Integrates operational practices within the department across all offices/regions
- Develops SAS programs to generate tables and listings without shells
- Develops SAS programs to generate listings, tables and graphs as outlined by TLF shells
- Develops SAS programs to generate CDISC and other analysis data sets as outlined by respective specifications
- Develops listing shells for SAP
- Develops and validates standard macros and template programs using SAS and other software tools
- Develops and validates general SAS macros
- Develops and implements non-SAS software
- Creates define packages for CDISC datasets
- Contributes to the tracking of project revenue and backlog
- Contributes to the tracking of hours worked on projects and forecasts hours to complete
- Contributes to the definition of standards and harmonized procedures across offices/regions
- Contributes to efforts in Biostatistics project costing estimates and change order process
- Capability and willingness to coach and mentor others
- Acts as Lead Biostatistical Programmer to interact with the Lead Biostatistician and the study team
What We Are Searching For
- BS or equivalent from accredited college or university, in statistics, IT, mathematics or equivalent experience with programming in a scientific field. Equivalent combination of education, training and experience will be considered.
- 15+ years’ experience in SAS programming within the area of clinical trials.
- 7+ years’ experience as supervisor/manager
- Demonstrated excellent knowledge of data processing, database design and organization in clinical data environment.
- Demonstrated excellent knowledge of basic clinical trial design and analysis principles.
- Excellent working knowledge of CDISC standards and application of these standards to projects.
- Excellent 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.
- Ability to support Biostatisticians with advanced statistics with little or no supervision on standalone projects. Advanced knowledge of SAS Software data set architecture, utilities, and programming
- techniques.
- Demonstrated working knowledge of advanced SAS macro development and code generation/management algorithms.
- Detail oriented, well organized. Excellent English Communication skills (verbal, written & interpersonal).
