Associate Director, Biostatistics
Premier Research helps highly innovative biotech and specialty pharma companies transform life-changing ideas into reality. We have positioned ourselves right in the middle of the action, targeting unmet needs in Rare Disease and Pediatrics, Analgesia, Neuroscience, Oncology, Dermatology, and Medical Devices.
We’re looking for a talented and energetic Associate Director, Biostatistics to join our team!
Working at Premier Research means being an individual - you will be recognized for what you do and you will truly have an impact in an aspiring, empowering and caring culture where people truly work as one team. You can grow and contribute your expertise with colleagues who are genuinely supportive regardless of location or seniority.
Premier Research is on an exciting journey - there is a true buzz throughout the company, so come and be part of it!
As the Associate Director, Biostatistics, you’ll have the opportunity to manage both technical and development aspects within our Biometrics Team. As a technical expert, you will showcase your expertise to provide strategic guidance within our projects, with particular emphasis on scientific rigor and application of ‘current’ statistical methodology. When functioning in a supervisory role, you’ll utilize your leadership talents to guide junior staff while overseeing the technical evolution of the departmental work product. In this role, you’ll also be able to represent the department during bid meetings and audits, as well as provide statistical advice throughout clinical projects.
What you’ll be doing:
- Review statistical aspects of development projects including choice of statistical methods; develop statistical analysis plans; create tables, listings, and graphs; sample size estimation; randomization schedules; and other relevant activities.
- Lead, develop and motivate, both individually and collectively, a Biostatistics team that is capable of meeting current and future project assignments; ensure that Biostatistics has the necessary training and resources to carry out responsibilities and reach milestones
- Ensure that managers have a common understanding of each project's scope, objectives, timeline and tasks and that the project is executed accordingly
- Serve as project manager for innovative stand-alone Biostatistics projects
- Serve 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; monitor and project the operational and financial status of the Biostatistics department's portion of the contract
- Coordinate the initiation, planning, and execution of Biostatistics project responsibilities, in collaboration with other team members and the project manager
- Create Biostatistical aspects of project plans for assigned studies and assist the project manager in integrating the departmental activities with the overall project plan
- Support Business Development by remaining alert for new business opportunities, network, and providing information to business development staff
- Participate and/or lead in quality improvement efforts to increase overall operational efficiency
- Work with Business Development to provide input into the compilation of contracts and proposals to establish estimated timings and costs.
You’ll need this to be considered:
- Advanced degree (MS or PhD or equivalent) in statistics or closely related field along with 8+ years practical experience in the field of data evaluation and statistics (preferably in a CRO, Healthcare or Pharmaceutical environment) including 3 years of leadership experience
- Proven knowledge and practical experience with FDA/ICH as well as 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
- Known for building client confidence and achieving high levels of customer satisfaction
- or exceptional performance as senior statistician in the company
- Maintain a positive working environment that embodies a culture of aspiration, caring, empowerment and a #oneteam approach; excellent team player who encompasses the management skills to motivate, enthuse and lead teams; accountable, dependable and strong commitment
- Excelled organizational and time-management skills with the ability to multitask, meet deadlines and work effectively in a fast-paced environment with competing priorities
- Self-starter with common sense and able to act on own initiative
- Ability to apply clear and consistent performance standards as well as identify concerns and resolve decisively and objectively