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 Principal Biostatistician is responsible for providing statistical expertise for company products within one or more therapeutic areas. As a lead statistician, the Principal Biostatistician will lead study designs, protocol development, analysis plans, file/report specifications, and review study setup activities, including but not limited to randomization, CRFs, and data edits. They will perform design studies, identify appropriate statistical methods, conduct analyses, interpret statistical results, and prepare clinical study reports, including integrated summaries for submissions as appropriate. As an active member of the Biometrics group, they will also aid in process improvement initiatives, stay abreast of current statistical methodology, and provide mentorship to new/junior biostatisticians.
Essential Duties and Responsibilities:
- Provide statistical expertise to support clinical development objectives and strategy, representing Biostatistics in cross-functional teams.
- Define statistical methodology, analyze data and reports results, and contribute to the strategic planning and execution of the clinical development plan for the assigned project; train and supervise contract statisticians and ensure their deliverables' quality.
- Serve as a content author or peer reviewer for material authored or coauthored by other statisticians and other clinical research personnel and acts as an internal consultant on broad statistical issues that impact the pharmaceutical/biotechnology industry.
- Provide written and verbal responses to statistical issues as part of regulatory, legal, corporate processes; may represent Biostatistics in critical meetings as assigned.
- Participate in approved process improvement initiatives; mentor new/junior biostatisticians; keep up-to-date on statistical methodology and software/tools. Conduct modeling and simulations as needed.
- Promote innovative statistical methodology approaches by identifying, adapting, and developing optimal statistical research methodologies and techniques.
- Contribute internally and externally to the company's development and visibility and the Biometrics department through their expertise and customer orientation.
- Develop strong collaboration and communication with cross-functional teams and Biometrics management.
Education and Experience:
- PhD (preferred) or master’s degree in Statistics, Biostatistics or related discipline.
- 15+ years (PhD 7-8 years or Masters + 10-11 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 global regulatory requirements. Extensive experience with written and verbal communications to regulatory agencies is a must.
- 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.
- Proficient with SAS, R, 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
- 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.
- Ability to influence without direct authority
- A detail-oriented, pro-active, enthusiastic, and goal-oriented personality
- 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.
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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