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Senior Vice President of Biometrics

2 months ago

Stamford, Connecticut, United States SpringWorks Therapeutics Full time
Job Overview

About SpringWorks Therapeutics:

SpringWorks is a biopharmaceutical organization focused on precision medicine, dedicated to developing transformative therapies for individuals facing severe rare diseases and cancer.

Our company boasts a comprehensive oncology pipeline that addresses both solid tumors and hematological malignancies, with an emphasis on clinical trials for rare tumor types and prevalent genetically defined cancers. Our strategic initiatives and operational excellence in clinical development have propelled our lead product candidates into advanced trials and fostered collaborations with industry and academic innovators to maximize the potential of our portfolio and enhance patient solutions in oncology.

Role Summary:

The Senior Vice President of Biometrics will oversee strategic planning, management, and execution of biostatistics, data management, and statistical programming throughout the clinical development lifecycle. This leader will head the Biometrics division, delivering a spectrum of quantitative research services, including study design, data management, analysis, reporting, and dissemination. Collaboration with cross-functional teams and external partners will be crucial to ensure that all data outputs are precise, timely, consistent, and uphold the highest quality standards for regulatory success.

The Senior Vice President of Biometrics will be a pivotal member of the Medical Leadership Team, reporting directly to the Chief Medical Officer. This role requires a strong commitment to patient service and a passion for improving the lives of individuals with serious health conditions.

Work Environment – Hybrid:

This position necessitates onsite work two days a week, or more as business needs dictate.

Key Responsibilities:

  • Provide strategic guidance and leadership to the biometrics division, ensuring alignment with corporate objectives and program goals.
  • Build, lead, and manage the biometrics team, encompassing biostatistics, data management, and statistical programming, while promoting a culture of collaboration and excellence.
  • Offer strategic consulting across functions regarding product development strategies, including statistical study design and sample size justification.
  • Review scientific proposals, study protocols, and final reports to ensure the appropriate application of statistical and data management methodologies.
  • Prepare and evaluate clinical data-related documentation, including protocols and data management plans.
  • Oversee external vendors responsible for clinical data deliverables, ensuring quality and timely completion of all related tasks.
  • Manage functional resource allocation for projects, ensuring timely and quality service delivery.
  • Perform additional duties as assigned.

Qualifications:

  • Education: Ph.D. in Biometrics, Biostatistics, Statistics, or a related scientific field.
  • 10 years of experience in biometrics, biostatistics, or related areas within the pharmaceutical or biotechnology sectors.
  • 5 years of experience in people management, including managing multiple functions.
  • Demonstrated leadership in drug development from early research through regulatory submission.
  • Extensive experience with regulatory submissions and interactions with global regulatory agencies.
  • Experience in conducting Phase 1-4 clinical trials and integration analyses for regulatory submissions.
  • Proficient in CDISC standards and SAS programming.
  • Strong analytical skills with expertise in clinical trial design and statistical methodologies.
  • Experience in oncology and/or rare disease therapeutic areas is preferred.
  • Exemplary leadership skills with the ability to inspire and motivate teams in a multi-functional environment.
  • Strong interpersonal communication skills for effective collaboration in a hybrid work setting.
  • Willingness to travel occasionally as required by business needs.

Compensation:

The anticipated salary range for this role is $296,000 to $393,000, with actual compensation determined by experience, qualifications, and other job-related factors. A discretionary annual bonus may be available based on individual and company performance.

We offer a comprehensive benefits package, including competitive compensation, annual bonuses, equity grants, 401K matching, and fully covered medical, dental, and vision plans.

SpringWorks Leadership Principles:

  • Change Steward: Embrace change and align goals with company strategy.
  • Excellence Driver: Foster high performance and accountability.
  • Growth Coach: Encourage continuous learning and development.
  • Community Builder: Create strong, collaborative teams in a diverse and inclusive environment.

DE&I Commitment: We are dedicated to fostering a culture of belonging and inclusivity.

EEO Statement: SpringWorks is committed to providing equitable employment opportunities to all individuals.