About SpringWorks Therapeutics

SpringWorks Therapeutics is a clinical-stage biopharmaceutical company applying a precision medicine approach to acquiring, developing, and commercializing life-changing medicines for underserved patient populations suffering from devastating rare diseases and cancer. SpringWorks has a differentiated portfolio of small molecule targeted oncology product candidates and is advancing two potentially registrational clinical trials in rare tumor types, as well as several other programs addressing highly prevalent, genetically defined cancers. SpringWorks’ strategic approach and operational excellence in clinical development have enabled it to rapidly advance its two lead product candidates into late-stage clinical trials while simultaneously entering into multiple shared-value partnerships with industry leaders to expand its portfolio.

The Head of Biostatistics will serve as a critical member of cross-functional teams contributing to the design and conduct of clinical studies at SpringWorks, including the evaluation, interpretation, and reporting of study results and regulatory submissions to health authorities. They will be 'hands-on' in biostatistical tasks, provide leadership and oversight of all statistical deliverables, and provide management and mentorship to biostatisticians as the team grows.

Essential Duties and Responsibilities:

  • Lead a team to design and implement statistical strategies and solutions to support all phases of clinical trials. Ensure timeliness and quality of all contributions and deliverables and compliance with health authority regulations, ICH/GCP guidelines, and company SOPs.
  • Serve as a statistical lead to support the clinical study team in statistical analyses and interpretation of efficacy and safety data for all early and late phases of clinical trials. Apply innovative approaches to study design, analysis, data modeling, exploration, and presentation methodologies, conduct modeling and simulations as needed, and remain current on statistical methods, trends, and software/tools.
  • Author relevant sections of regulatory submissions, represent SpringWorks at regulatory agencies, and participate in writing, reviewing, and finalizing abstracts and manuscripts for publication. Serve as a content author or peer reviewer for material authored or coauthored by other statisticians and other clinical research personnel and act as an internal consultant on broad statistical issues that impact the pharmaceutical industry. Provide written and verbal responses to statistical topics as part of regulatory, legal, and corporate processes. Represent Biostatistics in critical meetings as assigned.
  • Contribute to the development of department SOPs and best working practice guides. Participate in approved process improvement initiatives; mentor new/junior biostatisticians;
  • Develop and retain key talent by managing and mentoring biostatisticians, and others including contract personnel as needed to grow and foster a cohesive team.
  • Develop strong collaboration and communication with cross-functional teams and Biometrics management.

Education and Experience:

Education:

  • PhD (preferred) or master’s degree in Statistics, Biostatistics or related Biometrics discipline.

Experience:

  • 12+ years (PhD 5-6 years or Masters + 8-9 years) of related experience in statistical or biostatistical analysis supporting drug development, clinical trial operations, and worldwide regulatory submissions within the pharma/biotech industry. Experience within oncology is preferred. Experience supporting medical affairs, RWE/HEOR is a plus.  
  • Demonstrable knowledge of global regulatory guidelines (FDA, EMA, ICH) related to clinical trials, statistics, and data handling in a pharmaceutical research setting. Extensive experience with written and verbal communications to regulatory agencies is a must.
  • Experience in clinical trials through multiple BLA/NDA.
  • Extensive statistical modeling experience including, but not limited to complex statistical methods and models, principles of statistical inference, hypothesis testing, deriving estimates, parametric and non-parametric models, sample size calculations for comparing multiple arms, and phase I-IV clinical trial data analysis. Bayesian and adaptive design experience is preferred.
  • Ability to translate and implement a broad understanding of statistical principles for all phases of drug development. Ability to develop innovative/creative statistical/technical solutions to complex problems.
  • Experience with outsourcing biometrics activities and overseeing services provided by CROs and contractors preferred.

Skills:

Technical:

  • Proficient with SAS, Sample size calculation software (e.g., East, PASS, NQuery). Other analytical software is a plus.
  • Demonstrable experience using CDISC data standards, specifically ADaM. SDTM, CDASH, and other CDISC standards are a plus.
  • Ability to write statistical code and documentation

Leadership:

  • A strong team player with the ability to collaborate in cross-functional teams.
  • Able to work cooperatively and independently in a fast-paced, matrixed environment
  • Demonstrates ability to translate & present complex information to others effectively.
  • Demonstrated experience of leading a team by hiring, coaching and motivating team members.
  • A detail-oriented, pro-active, enthusiastic, and goal-oriented personality
  • Minimum of 5-7 years’ experience managing people in a direct setting is preferred.  

Communication:

  • Excellent communication and interpersonal skills to effectively interface with others
  • Must communicate, develop, and maintain strong relationships with regulatory agencies (e.g., FDA, PMDA, etc.), internal stakeholders, and external stakeholders (e.g., CROs). 
  • Practical technical writing skills, especially the ability to clearly and succinctly author regulatory documents.

Other:

  • Ability to travel domestically for meetings, as necessary.

 

Are you a SpringWorker?

How much do you care?
How well do you partner with others?
How fast do you move?
Are you a problem solver?
Are you comfortable challenging convention?

At SpringWorks Therapeutics, we ignite the power of promising science to unleash new possibilities for patients.   We work hard, we care even harder and we’re in it together.  We are looking for ambitious, smart, and hardworking colleagues to join our growing team.                                  

SpringWorks Therapeutics is an Equal Employment Opportunity employer. All qualified applicants/employees will receive consideration for employment without regard to that individual’s age, race, color, religion or creed, national origin or ancestry, sex (including pregnancy), sexual orientation, gender, gender identity, physical or mental disability, veteran status, genetic information, ethnicity, citizenship, or any other characteristic protected by law.

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Your personal data will be shared with Greenhouse Software, Inc., a cloud services provider located in the United States of America and engaged by Controller to help manage its recruitment and hiring process on Controller’s behalf. Accordingly, if you are located outside of the United States, your personal data will be transferred to the United States once you submit it through this site. Because the European Union Commission has determined that United States data privacy laws do not ensure an adequate level of protection for personal data collected from EU data subjects, the transfer will be subject to appropriate additional safeguards under the standard contractual clauses. You can obtain a copy of the standard contractual clauses by contacting us at hr@springworkstx.com.

Your personal data will be retained by Controller for as long as Controller determines it is necessary to evaluate your application for employment.  Under the GDPR, you have the right to request access to your personal data, to request that your personal data be rectified or erased, and to request that processing of your personal data be restricted. You also have to right to data portability. In addition, you may lodge a complaint with an EU supervisory authority.

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