USA - Sr Biostatistician

Description

What you will be doing at Client?

• Author and/or provide input on statistical sections of clinical study documents including protocols, electronic case report forms, randomization plans, data transfer specifications, statistical analysis plans, tables, listings, and figures (TLF) shells, SDTM/ADaM specifications, clinical study reports, and other relevant documents.
• Drive TLF development and TLF reviews with programming and other relevant team members, determine analysis populations, validate key analysis results, and present final analysis results to key stakeholders
• Accountability for 5 concurrent studies
• Represent the Statistics function in study team meetings
  
  

What you will bring to Client?

• Masters or PhD in Statistics
• 3-5 years recent/related statistical experience within a pharmaceutical and/or medical device company, or similar organization
• Experience with different clinical phases
• Knowledge of clinical trial methodology and study design
• Study-level statistical expertise
• Proficiency in SAS and knowledge of CDISC standards
• Strong working knowledge of statistical data analysis and data management principles
  
  

Remote ok

Senior Statistician

What you will be doing at Client

Author and/or provide input on statistical sections of clinical study documents including protocols, electronic case report forms, randomization plans, data transfer specifications, statistical analysis plans, tables, listings, and figures (TLF) shells, SDTM/ADaM specifications, clinical study reports, and other relevant documents.

Drive TLF development and TLF reviews with programming and other relevant team members, determine analysis populations, validate key analysis results, and present final analysis results to key stakeholders

Accountability for 5 concurrent studies

Represent the Statistics function in study team meetings

What you will bring to Client

• Masters or PhD in Statistics
• 3-5 years recent/related statistical experience within a pharmaceutical and/or medical device company, or similar organization
• Experience with different clinical phases
• Knowledge of clinical trial methodology and study design
• Study-level statistical expertise
• Proficiency in SAS and knowledge of CDISC standards
• Strong working knowledge of statistical data analysis and data management principles
  
  

Must Haves

Minimum 3-5 years’ recent stats experience

Pharma/Med Device

Master’s degree in stats

Ability to manager 5 studies at a time

Ability to work independently

Nice to haves

Actual med device experience

Experience in different industries

Ability to be proactive

Interview process:2-3 rounds depending on managers availability

1st round 1 hour phone screen with Megan

2nd/3rd round 30 minute interview with Deborah and 1 hour with panel

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Additional Details

• Does the position allow for the worker to be virtual/remote? : Yes
• Shore Options Available for this Position : Onshore Only
• Direct or Indirect : Indirect
• Kronos Worker? : No
• Shift : USA-1