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About SpringWorks Therapeutics
SpringWorks is a commercial-stage biopharmaceutical company applying a precision medicine approach to developing and delivering life-changing medicines for people with severe rare diseases and cancer.
SpringWorks has a diversified targeted oncology pipeline spanning solid tumors and hematological cancers, including clinical trials in rare tumor types and highly prevalent, genetically defined cancers. SpringWorks' strategic approach and operational excellence in clinical development have enabled it to rapidly advance its lead product candidates into late-stage trials and enter into multiple collaborations with innovators in industry and academia to unlock the full potential for its portfolio and create more solutions for patients with cancer.
Job Summary:
The Biostatistics Associate Director is responsible for providing statistical expertise within one or more studies within a therapeutic area and establishing strategic plans and objectives for biostatistics for multiple studies. As a study statistician, the Biostatistics Associate Director will contribute to study designs, protocol development, analysis plans, file/report specifications, and review study setup activities, including but not limited to randomization, CRFs, and data edits. As an active member of the Biometrics group, they will also aid in process improvement initiatives, stay abreast of current statistical methodology, and supervise junior/contract statisticians.
Essential Duties and Responsibilities:
- Establish strategic plans and objectives for biostatistics in one or more studies within a therapeutic area to support clinical development, 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 study within a therapeutic area.
- Provide written and verbal responses to statistical issues as part of regulatory, legal, corporate documents and processes; may represent Biostatistics in critical meetings as assigned.
- Manage/supervise new/junior/contract biostatisticians to ensure their deliverables' quality.
- Promote innovative statistical methodology approaches by identifying, adapting, and developing optimal statistical research methodologies and techniques.
- Participate in approved process improvement initiatives.
Education and Experience:
Education:
- PhD preferred in Statistics, Biostatistics or related discipline with 5+ years of experience
- Master's degree in Statistics, Biostatistics or related discipline with 7+ years of experience
Experience:
- Related experience in statistical or biostatistical analysis supporting late-stage drug development, clinical trial operations, and worldwide regulatory submissions within the pharma/biotech industry. Experience within oncology is preferred. Experience with early-stage drug development is desirable.
- Understanding of regulatory requirements supporting marketing authorization applications in the US, Europe, and Japan as well as experience with written and verbal communications to regulatory agencies is preferred.
- 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.
- Experience working with contractors and CROs is desired.
Skills:
Technical:
- Proficient with SAS, Sample size calculation software (e.g., East, PASS, NQuery). R and other analytical software is a plus.
- 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 and leader, with the ability to lead biostatistics deliverables for multiple studies in a therapeutic area and 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
Communication:
- Excellent communication and interpersonal skills to effectively interface with others
- Must communicate well, bother verbally and orally with internal and external stakeholders (e.g., CROs).
- Practical technical writing skills, especially the ability to do so clearly.
Other:
Ability to travel domestically for meetings, as necessary is required
The expected salary range for this position is $155,000 – $200,000. Actual pay will be determined based on experience, qualifications, and other job-related factors permitted by law. A discretionary annual bonus may be available based on individual and Company performance
We also offer a comprehensive benefits package for our team of SpringWorkers and their families, including competitive compensation, annual cash bonuses and equity grants, 401K matching, fully covered medical, dental, and vision plans, and a full week of holiday break at year end. It's the right thing to do – and helps us be healthy, happy, and at our best for the people who need us.
At SpringWorks, we believe in fostering a culture of belonging. Our Employee Resource Group's (ERG) mission is to boldly live the SpringWorks values, provide resources, and deeply engage SpringWorkers and the communities we serve to foster a culture of belonging. Ensuring diversity, equity, and inclusion are integral to our organization's DNA.
SpringWorks maintains an EEO Policy providing for equitable opportunities for employment and conditions of employment to all employees and applicants regardless of actual or perceived sex (including pregnancy, childbirth, breastfeeding or related medical conditions), gender, gender identity or gender expression, sexual orientation, partnership status, marital status, familial status, pregnancy status, race, color, national origin, ancestry, caste, religion, religious creed, age, alienage or citizenship status, veteran status, military status, physical or mental disability, past or present history of mental disorder, medical condition, AIDS/HIV status, sickle cell or hemoglobin C trait, genetic predisposition, genetic information, protected medical leaves, victims of domestic violence, stalking, or sex offense, political affiliation and any and all other characteristics or categories protected by applicable federal, state or local laws. SpringWorks treats all employees and applicants fairly in the selection process (and in other personnel activities) by giving all employees and applicants the same opportunities for employment. SpringWorks' Equal Employment Opportunity Policy is intended to ensure that there are no barriers that would prevent members of a protected group from a fair and equitable opportunity to be hired, promoted, or to otherwise take advantage of employment opportunities.
This Equal Employment Opportunity Policy applies to all aspects of employment, including, without limitation, recruitment, hiring, placement, job assignment, promotion, termination, transfer, leaves of absence, compensation, discipline, and access to benefits and training. Any violation of this Policy will result in disciplinary action up to and including termination of employment.
GDPR Statement: When you apply to a job on this site, the personal data contained in your application will be collected by SpringWorks Therapeutics ("Controller"), which is located at 100 Washington Blvd, Stamford CT 6902 and can be contacted by emailing hr@springworkstx.com . Your personal data will be processed for the purposes of managing Controller's recruitment related activities, which include setting up and conducting interviews and tests for applicants, evaluating and assessing the results thereto, and as is otherwise needed in the recruitment and hiring processes. Such processing is legally permissible under Art. 6(1)(f) of Regulation (EU) 2016/679 (General Data Protection Regulation) as necessary for the purposes of the legitimate interests pursued by the Controller, which are the solicitation, evaluation, and selection of applicants for employment.
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.
