Director, Biostatistics - Remote
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 Director, Biostatistics 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.
What you'll be doing:
- Reviews statistical aspects of development projects including choice of statistical methods; development of statistical analysis plans; creation of tables, listings, and graphs; sample size estimation; randomization schedules; and other relevant activities.
- Serves on corporate committees and/or projects as appropriate and works on internal projects
- Ensures that Biostatistics personnel have the necessary training and resources to carry out assigned responsibilities
- Develops and motivates, both individually and collectively, a Biostatistics team that is capable of meeting current and future project assignments
- Ensures that managers have a common understanding of each project's scope, objectives, timeline and tasks and that the project is executed accordingly
- Acts as project manager for stand-alone Biostatistics projects, and works with members of the project team
- Serves as core team member for the projects comprising a program, which includes supervising the initiation, planning, and execution of all Biostatistics related tasks awarded to the department per contract as well as monitoring and projecting the operational and financial status of the Biostatistics department's portion of the contract
- Coordinates in detail, the initiation, planning, and execution of Biostatistics project responsibilities, in collaboration with other team members and the project manager.
- Creates and monitors Biostatistical aspects of project plans for assigned studies and assists the project manager in integrating the departmental activities with the overall project plan
- All other projects as assigned
- Maintain overall awareness in the field of biostatistics by reading related literature, attending training classes, professional meetings, statistical conferences etc.
- Update CV and training records as necessary and make available for client review and ensure direct reports keep training records up to date during annual reviews
- Keep detailed records of time spent on each project to allow accurate billing especially for additional or new work requested
- 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
- Remain alert for new business opportunities, network, and provides information to business development staff or manager
- Participate in quality improvement efforts to increase overall operational efficiency
- Report any hardware or software problems promptly to the IT manager for prompt corrective action
- Communicate via electronic mail acknowledging and sending correspondence in a professional, timely manner
- Work with business development providing input into the compilation of contracts and proposals to establish estimated timings and costs. Also to inform business development of any prior knowledge of clients where this may be helpful
- Perform other work-related duties as assigned
What you'll need:
- Advanced degree (MS or PhD or equivalent) in statistics or closely related field
- 8+ years practical experience in the field of data evaluation and statistics (preferably in a Contract Research Organization or Pharmaceutical Company) or exceptional performance as senior statistician in the company
- Good management and team leadership skills, 4-6 years leadership experience
- Good knowledge and practical experience with FDA/ICH.
- Demonstrated experience with interacting with regulatory agencies (e.g. FDA, MHRA, EMEA, EU member states)
- Strong computer skills, with evidence of advanced SAS programming skills
- Building of client confidence and achieving high levels of customer satisfaction
- Ability to be productive and handle multiple tasks to meet deadlines in a dynamic environment
- Requires strong planning and organizational skills, verbal and written
- Superior English communication skills, delivers presentations effectively, good at listening and sharing information with others
- Ability to act on their own initiative
- A willingness to travel, ~20%
- Motivated, self-starter that has a very high degree of creative thinking.