Associate Director Biostatistics

Associate Director of Biostatistics

Job Overview: Who are they?

We have recently partnered with a company at the forefront of the biopharmaceutical industry, who’s goal is to reduce the suffering of people with life-changing therapies by harnessing the potential of the immune system to develop novel therapies against cancer and infectious diseases.

Main Responsibilities:

• Represent Statistics in cross-functional project and study teams in multiple projects
• Provide statistical input into clinical development plans, clinical study protocols, clinical study reports, regulatory submission documents, and publications ensuring accurate deliverables
• Perform sample size calculations, develop statistical analysis plans and lead TLF development
• Perform statistical analyses and validate analysis results
• Oversee outsourced statistical CRO activities and deliverables ensuring highest quality
• Develop, implement and improve statistical processes and standards
• Support and participate in the development of departmental strategies
• Interact with global regulatory authorities

What can you bring to the table?

• PhD or Masters in Statistics or Biostatistics
• 6+ years of experience in the Pharmaceutical Industry and/or CRO including submission experience
• Excellent knowledge of clinical study designs, statistical methods, adaptive designs, regulatory guidelines (ICH, FDA, EMA) and statistical software like SAS, EAST, and R
• Awareness of the bigger picture, strong orientation to quality, innovative and solution orientated thinking
• Preferred experience with clinical study designs in Oncology or Infectious Diseases

What’s in it for you?

💰 Salary up to £90,000

✅ Collaborative and inspirational working environment / atmosphere

🏡 Excellent employment package and work/life balance

What is the next step

Interested? Drop me a message or send your CV to shane@warmanobrien.com receive more details surrounding this role and discuss this further!

Associate Director of Biostatistics

Job Overview: Who are they?

We have recently partnered with a company at the forefront of the biopharmaceutical industry, who’s goal is to reduce the suffering of people with life-changing therapies by harnessing the potential of the immune system to develop novel therapies against cancer and infectious diseases.

Main Responsibilities:

• Represent Statistics in cross-functional project and study teams in multiple projects
• Provide statistical input into clinical development plans, clinical study protocols, clinical study reports, regulatory submission documents, and publications ensuring accurate deliverables
• Perform sample size calculations, develop statistical analysis plans and lead TLF development
• Perform statistical analyses and validate analysis results
• Oversee outsourced statistical CRO activities and deliverables ensuring highest quality
• Develop, implement and improve statistical processes and standards
• Support and participate in the development of departmental strategies
• Interact with global regulatory authorities

What can you bring to the table?

• PhD or Masters in Statistics or Biostatistics
• 6+ years of experience in the Pharmaceutical Industry and/or CRO including submission experience
• Excellent knowledge of clinical study designs, statistical methods, adaptive designs, regulatory guidelines (ICH, FDA, EMA) and statistical software like SAS, EAST, and R
• Awareness of the bigger picture, strong orientation to quality, innovative and solution orientated thinking
• Preferred experience with clinical study designs in Oncology or Infectious Diseases

What’s in it for you?

💰 Salary up to £90,000

✅ Collaborative and inspirational working environment / atmosphere

🏡 Excellent employment package and work/life balance

What is the next step

Interested? Drop me a message or send your CV to shane@warmanobrien.com receive more details surrounding this role and discuss this further!