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Senior Vice President of Biometrics

2 months ago

Raleigh, North Carolina, United States SpringWorks Therapeutics Full time
About SpringWorks Therapeutics:

SpringWorks is a commercial-stage biopharmaceutical organization dedicated to a precision medicine strategy for developing and delivering transformative therapies for individuals with severe rare diseases and cancer.

Our diversified oncology pipeline encompasses solid tumors and hematological malignancies, including clinical investigations in rare tumor types and prevalent, genetically defined cancers. SpringWorks' strategic methodology and operational excellence in clinical development have facilitated the swift advancement of our lead product candidates into late-stage trials and fostered multiple collaborations with innovators in both industry and academia to unlock the full potential of our portfolio and create additional solutions for patients battling cancer.

SpringWorks Leadership Principles:
  • Change Steward: Acknowledge that change is vital; establish objectives that align with the Company's strategy and generate positive momentum for transformation; modify business practices as necessary to adapt to evolving requirements.
  • Excellence Driver: Propel high performance and accountability through open dialogue; acknowledge achievements, empower teams, and create accountability for outcomes.
  • Growth Coach: Set clear expectations, provide regular feedback, coaching, and promote continuous learning; leverage individual strengths to assist SpringWorkers in realizing their potential and advancing in their careers.
  • Community Builder: Forge connections with others to cultivate strong teams that trust one another and excel in collaboration to achieve objectives; foster a diverse, inclusive, and psychologically safe environment.
About the Role:

The Senior Vice President of Biometrics will be accountable for strategic planning, oversight, and delivery of biostatistics, data management, and statistical programming functions throughout the clinical development program lifecycle. This role will lead the Biometrics function, offering a variety of services for quantitative research, including but not limited to study design, data management, data analysis, data reporting, and data dissemination. The Senior Vice President will collaborate strategically with cross-functional teams and external partners to ensure that all data deliverables are accurate, timely, consistent, and executed to the highest quality standards to guarantee regulatory success.

As a senior member of the Medical Leadership Team, this position reports to the Chief Medical Officer. Like all leaders at SpringWorks Therapeutics, the Senior Vice President of Biometrics will possess a profound commitment to serving patients and a passion for transforming the lives of individuals with serious diseases and their families.

Key Responsibilities:
  • Provide strategic direction and leadership to the biometrics function, ensuring alignment with senior leadership, corporate goals, and program objectives.
  • Build, lead, and manage the biometrics function, including biostatistics, data management, and statistical programming while nurturing a culture of collaboration, innovation, and excellence.
  • Offer strategic consulting across functions regarding product development strategies, including development options, statistical study design, endpoint specification, and sample size determination/justification.
  • Review scientific proposals, study protocols, papers, and final study reports to ensure the appropriate application of statistical and data management procedures and interpretations.
  • Prepare and review clinical data-related documentation, including clinical protocols, data management plans, and case report forms.
  • Oversee the performance of external vendors responsible for clinical data deliverables, ensuring quality completion of all clinical data-related outputs.
  • Manage functional resource allocation; assign resources for each project based on service scope; supervise to ensure timely and quality delivery and provide guidance as needed.
  • Perform additional duties and responsibilities as assigned.
Qualifications:
  • Education: Ph.D. in Biometrics, Biostatistics, Statistics, or a related scientific discipline.
  • 10 years of experience in biometrics, biostatistics, statistics, data management, statistical programming, or related areas within the pharmaceutical/biotechnology sector.
  • 5 years of people management experience, including managing multiple functions.
  • Proven leadership track record in drug development, from early-stage research to regulatory submission and approval.
  • Extensive experience with regulatory submissions and interactions with global regulatory agencies and health authorities.
  • Experience in conducting Phase 1-4 clinical trials and integration analyses for regulatory submissions.
  • Hands-on experience and thorough understanding of CDISC standards.
  • Strong programming skills, particularly in SAS, including data manipulations and statistical procedures.
  • Exceptional analytical and problem-solving abilities, with expert knowledge of clinical trial design and regulatory guidelines.
  • Solid statistical expertise in analyzing various outcomes in the presence of missing data.
  • Experience in oncology and/or rare disease therapeutic areas is preferred.
  • Demonstrated values-driven leadership qualities and a history of achievement as a senior leader within the biotechnology or pharmaceutical industry.
  • Strong interpersonal communication skills to collaborate effectively in a remote hybrid work environment.
  • Ability to travel occasionally as business needs dictate.
Compensation:

The expected salary range for this position is competitive and will be determined based on 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 for our team, including competitive compensation, annual cash bonuses, equity grants, 401K matching, and fully covered medical, dental, and vision plans.