Exel

Exel

Vice President, Biostatistics

Alameda, CA · Exec · Contract

Sponsorship not specified$360k-$418kDetected 15 days ago
Data ScienceStatisticsClinical TrialsFDA RegulatoryPharmacovigilanceLeadershipCollaborationBiostatistics

About the role

  • Participates in establishing drug development strategy and direction.
  • SUPERVISORY RESPONSIBILITIES: - Directly supervises employees. - Indirectly supervises employees via subordinate management.

Responsibilities

  • In collaboration with the product development teams and through subordinate management, leads the effective development and implementation of strategies consistent with the company's strategic objectives, and ensures the overall effective operations of the biostatistics, and Biostatistics associated tools and processes
  • Works with project clinicians to design, develop, conduct, and analyze Phase I - IV clinical protocols and statistical analysis plans.
  • Identifies and implements appropriate statistical and data-presentation methods for regulatory and publication purposes.
  • Develops productive relationships with cross functional leaders in the clinical, regulatory, drug safety, and other peer functional groups.
  • Senior data science and biometrics (DSB) representative on internal executive committees including a protocol/clinical document review committee, strategic- and partner joint- development committees, and drug safety committees.
  • Provided statistical leadership and strategies for Real World Data (RWD) access and analysis. Sets up and maintains statistical science and methodological team, and provides methodological guidence to the organization.
  • Responsible for developing and maintaining department and biostatistics CRO budgets within corporate fiscal targets.
  • Successful track record of the management of clinical studies, from Phase I - III in support of US NDA filings.
  • Proven ability to translate strategy into implementation that leads to results; strong track record of performance excellence meeting milestones and objectives.
  • Proven ability to deliver on measures of performance in areas of responsibility.

Requirements

  • BA/BS in related discipline and a minimum of twenty-one years of relevant experience in the pharmaceutical industry
  • MA/MS in related discipline and a minimum of nineteen years of relevant experience in the pharmaceutical industry
  • PhD in related discipline and a minimum of seventeen years of relevant experience in the pharmaceutical industry
  • It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities and qualifications required of employees assigned to the job.

Skills

  • Education/Experience:
  • BA/BS in related discipline and a minimum of twenty-one years of relevant experience in the pharmaceutical industry; or,
  • MA/MS in related discipline and a minimum of nineteen years of relevant experience in the pharmaceutical industry; or,
  • PhD in related discipline and a minimum of seventeen years of relevant experience in the pharmaceutical industry; or,
  • Equivalent combination of education and experience.
  • Experience/The Ideal for Successful Entry into Job:
  • PhD in related field strongly preferred
  • The ability to articulate a vision and strategy in a way that inspires and motivates teams to achieve results.
  • Direct experience with FDA/EU regulatory authority.
  • The base pay range for this position is $360,000 - $418,000 annually.
  • Employees are also eligible for a discretionary annual bonus program, or if field sales staff, a sales-based incentive plan.

Compensation

  • The base pay range for this position is $360,000 - $418,000 annually.

Benefits

  • In addition to educational requirement, at least 15 years progressive experience in biostatistics, including at least 8 years of progressive functional area management background through at least senior director level
  • Interacts with executive leadership to establish vision, execute decisions, manage risk, and influence activities that affect the long-term viability of the Biostatistics department and the company.

Company info

  • Responsible for the development and oversight of biostatistics, and associated Biostatistics related tool and process strategies, operations, and personnel to ensure the efficient, accurate and timely collection and analysis of clinical trial data while ensuring high standards of data integrity and quality.
  • Develops and implements company policy, practices and operating procedures in compliance with industry standards to optimize compliance, effectiveness and efficiency.

Visa & Work Authorization

  • Provides executive leadership for sponsor/CRO activities, relationships and escalation resolution
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This listing is sourced directly from Exel's careers page and normalized into a canonical job model.