Senior Director, Biostatistics

Posted 7 Days Ago
Be an Early Applicant
Hiring Remotely in United States of America
Remote
200K-200K Annually
Senior level
Biotech • Pharmaceutical
The Role
Lead and manage biostatistics operations, provide strategic statistical consultancy, oversee project progress and finances, mentor staff, ensure CDISC compliance, support business development and regulatory interactions, and drive process improvements.
Summary Generated by Built In
Premier Research is looking for a Senior Director, Biostatistics 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 here to help you grow, to give you the skills and opportunities to excel at work with the flexibility and balance your life requires.

  • Your ideas influence the way we work, and your voice matters here.

  • As an essential part of our team, you help us deliver the medical innovation that patients are desperate for.

Join us and build your future here.

hat 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

  • Capability and willingness to coach and mentor others

  • Ability to lead process improvement efforts

  • Develop and maintain overall awareness in the field of biostatistics by reading related literature, attending training classes, professional meetings, statistical conferences etc.

  • Integrates operations between Biostatistics and other departments to obtain increased productivity, efficiency and quality

  • Provides oversight and reporting of project progress and financial health within Biostatistics

  • Develops and implements strategies to actualize goals

  • Strategic responsibility for all staffing and operational aspects of the allocated Biostatistics group

  • Provides consultancy to sponsors on statistical issues

  • Peer reviews draft statistical analysis plans and provides feedback

  • Support business development through participation in bid defenses, capabilities presentations, RFP strategy and build trusted scientific relationships with sponsors and influence decision-making through evidence-based recommendations. 

What we're looking 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. 

  • ​12+ years’ experience in clinical trials design and analysis 

  • ​7+ years’ experience as supervisor/manager 

  • ​Excellent demonstrated working 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 

  • ​Strong computer skills, with evidence of advanced SAS programming skills especially statistical inferential procedures 

  • ​Demonstrated experience in interacting with regulatory agencies (e.g. FDA, EMA, EU member states) 

  • ​Ability to motivate and lead a team of varying levels of status and ability​ 

Specific experience in Rare Disease/Specialty is highly desirable

Premier Research is dedicated to providing compensation that is fair and competitive with market standards. The annualized minimum base pay for this role is $200,000.00 USD. The actual salary will be influenced based on a variety of factors such as the candidate’s qualifications, skills, competencies, and proficiency for the role. We also offer a comprehensive benefits package, which may include health insurance, retirement plans, and paid time off.

Premier Research is proud to be an equal opportunity employer that is compliant with all federal guidelines. All qualified applicants will receive equitable consideration without regard to race, color, religion, sexual orientation, gender identity, national origin, disability or veteran status

Skills Required

  • Advanced degree (MS or PhD) in statistics or closely related field
  • 12+ years' experience in clinical trials design and analysis
  • 7+ years' experience as supervisor/manager
  • Excellent working knowledge of basic clinical trial design and analysis principles
  • Excellent working knowledge of CDISC standards and application
  • Excellent understanding of advanced statistical concepts
  • Advanced SAS programming skills, especially statistical inferential procedures
  • Demonstrated experience interacting with regulatory agencies (FDA, EMA, EU member states)
  • Ability to motivate, lead, coach, and mentor teams
  • Ability to manage and de-escalate difficult client and team situations
  • Experience in staffing, operational oversight, project financial reporting, and process improvement
  • Specific experience in Rare Disease/Specialty
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The Company
HQ: Morrisville, NC
2,279 Employees
Year Founded: 1989

What We Do

We’re out to change the course of medical science. Are you ready to rise to the challenge? Premier Research is not about being everything to everyone. Instead, our deep, focused expertise targets the therapeutic areas and indications where today’s biotech and specialty pharma pioneers are doing the most amazing work. We’re 1,500 employees strong and operate in more than 20 countries, delivering unmatched expertise, operational skills, and dedication to meeting customers’ most challenging needs. Join us and meet some of the brightest minds in clinical development today — people who apply their best thinking to every project, recognizing that what they do significantly affects the lives and well-being of customers, patients, physicians, and colleagues. You’ll enjoy great benefits and very flexible working conditions in a company that values your contributions, rewards your achievements, and is committed to helping you reach your full potential. Are you ready to make a real difference and help us transform this exciting industry? Follow our company page for more information about us and the work we do, and check out our current openings for your next career move!

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