Director, Biostatistical Science

Premier Research is looking for a **Director Biostatistical Science **to join our** Statistics** 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 BiotechSM.** Join us and build your future here.**

**What you'll be doing**:

- Ability to manage and de-escalate difficult situations with clients, teams, and management
- Demonstrated critical thinking with a history of bringing forward strategic initiatives
- Ability to coach and mentor others, to lead process improvement efforts
- Provides internal consultancy to team members (internal/external to Biostatistics) on statistical issues
- Provides consultancy to sponsors on statistical issues
- Acts as project manager for biostatistics stand-alone work
- Leads Cross-functional initiatives/effective change management of process or technical improvements that improve operations and department standards practices
- Regularly gives presentations on relevant industry topics to Biostatistics department
- Contributes to the definition of standards and harmonized procedures across offices/regions by developing templates and guidelines as well as training materials
- Acts as an SME for at least one Biostatistical area (e.g., Bayesian, Adaptive, etc)
- 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
- Keeps detailed records of time spent on each project to allow accurate billing
- Develops and maintains expert level awareness in the field of biostatistics by reading related literature, attending training classes, professional meetings, statistical conferences etc.
- Participates in the development, maintenance and adherence to departmental training, SOPs and guidelines
- Acts as an independent biostatistician on DSMBs and DMCs
- Attend project team meetings as required to oversee and support study teams
- Provides statistical input to Clinical Trial Reports and Clinical Trial Protocols
- Participates in and contributes to the training and development of new biostatisticians
- Supports Business Development concerning budget and proposal development
- Presents biostatistical capabilities in bid defense meetings
- Provides oversight in all aspects of project work along with interactions with the study team and the sponsor along with other tasks which may include:
**What we are searching for**:

- Advanced degree (MS or PhD) from accredited college or university, in statistics or closely related field. Equivalent combination of education, training and experience will be considered.
- Previous experience in clinical trials design and analysis and technical leadership role
- Excellent demonstrated working knowledge of advanced clinical trial design and analysis principles.
- Strong computer skills, with knowledge of advanced programming skills especially statistical inferential procedures
- Demonstrated experience in interacting with regulatory agencies (e.g., FDA, EMA, EU member states)
- Excellent English and Host Country Communication skills (verbal, written & interpersonal).
- Quality oriented, well organized.
- Ability to work in fast paced environment, to act on own initiative
- 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
- Ability to communicate basic statistical concepts to other scientists and nonscientists

**Why choose Premier Research?**
- Premier Research is more than a company - it’s a community of people that truly care about one another, about our clients, and about our mission of furthering research to improve the lives of patients in critical need.
- Our Values - We Aim High, We Work Together, We Stay Agile, We Get It Done, We Care - mirror the determination, flexibility and trust that our team embodies. As a Premier team member, you have the power to make an impact, regardless of job title and location.
- Our dedication to biotech and specialty pharma is unlike any other. We provide our staff with innovative technologies and continuous learning opportunities so that they have the tools they need to be successful.

Because we are transforming life-changing ideas into new medical treat