Premier Research Logo

Premier Research

Senior Director, Biostatistics

Posted 3 Days Ago
Be an Early Applicant
Remote
Hiring Remotely in United States of America
Senior level
Remote
Hiring Remotely in United States of America
Senior level
Lead and operationally manage a biostatistics group supporting clinical trial design, analysis, regulatory interactions, staffing, financial oversight, process improvements, mentorship, peer review of SAPs, and business development for biotech, medtech, and specialty pharma clients.
The summary above was generated by AI
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.

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

  • 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

Similar Jobs

5 Hours Ago
In-Office or Remote
Mid level
Mid level
Cloud • Information Technology • Internet of Things • Machine Learning • Software • Cybersecurity • Infrastructure as a Service (IaaS)
Operate and manage IP-backbone security devices for a telecom network, including multi-vendor firewalls, IPS, F5 modules and DDoS solutions. Secure and monitor Gi traffic and inter-node communications, troubleshoot incidents and performance issues, define threats and mitigation plans, implement security access requests, support backbone upgrades, and handle on-call and vendor (3PP) cases.
Top Skills: Authentication ServersDdos Mitigation SolutionsF5 AfmF5 AsmF5 GtmF5 LtmFirewallsFortinetGgsnGi InterfaceIp-RanIpsJuniper SrxLoad BalancersOssScripting/AutomationSigtranSs7Token Servers
5 Hours Ago
In-Office or Remote
Senior level
Senior level
Cloud • Information Technology • Internet of Things • Machine Learning • Software • Cybersecurity • Infrastructure as a Service (IaaS)
Provide EHS advisory and assurance across managed services projects, embedding Target Zero safety culture. Assess and mitigate EHS risks, review RAMS/CPHSP, ensure CDM 2015 and statutory compliance, support incident investigations and corrective actions, track KPIs, and coach stakeholders and contractors on safety.
5 Hours Ago
In-Office or Remote
Senior level
Senior level
Cloud • Information Technology • Internet of Things • Machine Learning • Software • Cybersecurity • Infrastructure as a Service (IaaS)
Lead EHS governance and act as the primary EHS point of contact for Vodafone Egypt. Ensure compliance with regulatory, customer, and Ericsson OHS frameworks; manage contractor EHS processes; conduct audits, inspections, incident investigations, and reporting; drive corrective actions, KPI tracking, emergency preparedness, and continuous improvement across field operations and CSS MEA.

What you need to know about the Austin Tech Scene

Austin has a diverse and thriving tech ecosystem thanks to home-grown companies like Dell and major campuses for IBM, AMD and Apple. The state’s flagship university, the University of Texas at Austin, is known for its engineering school, and the city is known for its annual South by Southwest tech and media conference. Austin’s tech scene spans many verticals, but it’s particularly known for hardware, including semiconductors, as well as AI, biotechnology and cloud computing. And its food and music scene, low taxes and favorable climate has made the city a destination for tech workers from across the country.

Key Facts About Austin Tech

  • Number of Tech Workers: 180,500; 13.7% of overall workforce (2024 CompTIA survey)
  • Major Tech Employers: Dell, IBM, AMD, Apple, Alphabet
  • Key Industries: Artificial intelligence, hardware, cloud computing, software, healthtech
  • Funding Landscape: $4.5 billion in VC funding in 2024 (Pitchbook)
  • Notable Investors: Live Oak Ventures, Austin Ventures, Hinge Capital, Gigafund, KdT Ventures, Next Coast Ventures, Silverton Partners
  • Research Centers and Universities: University of Texas, Southwestern University, Texas State University, Center for Complex Quantum Systems, Oden Institute for Computational Engineering and Sciences, Texas Advanced Computing Center

Sign up now Access later

Create Free Account

Please log in or sign up to report this job.

Create Free Account