Associate Director, Biostatistics - Remote

Biostatistics United States


Description

Position at Premier Research

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 Associate 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.


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


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