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Associate Director, Biostatistics

2 hours, 20 minutes ago
United States
Full-time
Lead
Data Scientist
Data Science and Analytics
GCP R
Apply Now
Summit Therapeutics

Summit Therapeutics

Summit Therapeutics is a clinical stage drug discovery and development company dedicated to advancing innovative therapies to address serious unmet medical needs. With a focus on oncology, Summit is committed to improving the quality of life and increa...

Pharmaceuticals
51-250
Founded 2003
View All Jobs 2

Description

  • Provide statistical support for oncology clinical development and clinical studies.
  • Conduct sample size calculations and develop statistical analysis plans, data presentation plans, and DMC charters.
  • Collaborate with clinical operations, data management, and CRO partners on CRFs, database design, and data quality planning.
  • Review protocol, vendor data transfer specifications, ADaM specifications, statistical outputs, and other study documents.
  • Perform statistical analyses, verify clinical data accuracy, apply appropriate methods, and interpret study results.
  • Support interim reports and final clinical study reports with clinical and cross-functional teams.
  • Contribute to manuscripts for publication and ensure accurate statistical reporting.
  • Develop and implement new statistical methodologies to improve study design and analysis.
  • Review safety reporting, biomarker analyses, and other clinical trial monitoring activities.
  • Help develop and implement biostatistics department policies, standards, procedures, and work instructions.

Requirements

  • Ph.D. in Statistics, Biostatistics, or a related area with 6+ years of biopharmaceutical industry experience, or an MS in a related discipline with extensive industry and leadership experience (8+ years).
  • Strong proficiency with biostatistics tools such as SAS and R.
  • Good understanding of clinical trial processes and statistical programming requirements.
  • Working knowledge of ICH, FDA, and GCP regulations and guidelines.
  • Attention to detail, accuracy, and confidentiality.
  • Clear and concise oral and written communication skills.
  • Ability to multi-task and manage time-sensitive, highly confidential documents.
  • Ability to communicate complex ideas clearly and effectively.
  • Ability to work in a fast-paced, demanding, and collaborative environment.

Benefits

  • Base salary range of $190,000 to $210,000 USD.
  • Eligibility for bonus compensation.
  • Potential stock-based compensation.
  • Additional benefits as part of the total compensation package.
  • Equal opportunity employer with a commitment to workplace diversity.

Interested in this position?

Apply directly on the company website

Apply Now

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