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.
Job Summary:
The Senior Biostatistician II is responsible for providing statistical support to company products within a specific therapeutic area. They will interact cross-functionally with clinical study teams to ascertain needs and develop the appropriate design and statistical solutions. The Senior Biostatistician II will work independently or collaboratively to identify appropriate statistical methods, author or co-author the statistical considerations for sections of the protocol, the statistical analysis plans (SAPs), and statistical reports contributing to clinical study reports and integrate analyses.
Essential Duties and Responsibilities:
- Provides statistical input to the clinical trial design with appropriate statistical methods and adequate sample size for statistical justification.
- Responsible for clearly communicating the study design and statistical methodology in key section of the protocol.
- Authors or co-authors statistical analysis plans as needed to capture design elements and statistical methodology including specifications for tables, listings, figures, analysis datasets, and consistency checks)
- Provides written and verbal responses to statistical issues as part of regulatory processes; may represent Biostatistics in critical meetings as assigned.
- Performs Quality Assurance (QA) and Quality Control (QC) for statistical analyses by other biostatisticians, programmers, or vendors to ensure analysis quality and data integrity.
- Contribute internally and externally to the company's development and visibility and the Biometrics department through their expertise and customer orientation.
- Maintains expertise in state-of-the-art data manipulation and statistical analyses.
Education and Experience:
Education:
- PhD (preferred) or master’s degree in Statistics, Biostatistics or related discipline.
Experience:
- 12 years (PhD 4-5 years or Masters + 7-8 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.
- Demonstrable knowledge of the US regulatory requirements. An understanding of global regulatory requirements. Experience with written and verbal communications to regulatory agencies is a plus.
- 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 late stage (Ph II, III, and IV) clinical trial design and analysis. Bayesian and adaptive design experience as well as early-stage development is a plus.
Skills:
Technical:
- Experienced with programming in SAS and sample size software (e.g. East, PASS, Nquery); familiarity with S-Plus/R is a plus.
- Experienced with CDISC data standards, specifically ADaM.
- Ability to translate methodology into statistical code and documentation.
Leadership:
- Able to work cooperatively and independently in a fast-paced, matrixed environment.
- A strong team player with the ability to collaborate in cross-functional teams.
Communication:
- Excellent written and verbal communication skills
- Demonstrable experience in supporting verbal and/or writing communication with the US regulatory agency. Global history is a plus.
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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