Senior Director, Biostatistician
Job Description
Are you ready to join a team committed to making a meaningful impact on cancer treatment through the discovery and development of precision medicines? At Kura Oncology, you have an opportunity to be a part of something bigger, with a lasting impact that you can be proud of.
At Kura Oncology, we are working to change the paradigm and improve the science of cancer treatment. As an organization, we strive to cultivate a diverse and talented professional culture driven to develop precision medicine therapeutics.
As we continue to build a leading biotech organization with a strong culture, a patient-focused mindset and a team focused on relentless execution, we are looking for innovative, passionate professionals to join us and make our vision a reality.
To succeed at Kura, you will need to have a demonstrated ability for excellence in drug discovery and development and a roll-up your sleeves attitude. The ideal candidate will possess a values-driven work style where integrity and grit drive all behaviors, decisions, and actions.
Essential Job Functions
ESSENTIAL JOB FUNCTIONS:
The Senior Director Biostatistics is responsible for providing technical leadership and biostatistical support to Clinical Development through the design and conduct of clinical studies; review and accuracy of clinical data; the evaluation, interpretation, and reporting of study results; and regulatory submissions to the FDA and other regulatory agencies.
- Lead the development and execution of statistical aspects for multiple complex clinical trials, including innovative designs with interim analyses, biomarker and surrogate endpoint evaluations, and multiplicity control.
- Provide strategic input on study design, analysis planning, study results presentation and interpretation, clinical study report authoring, regulatory submissions, and publications.
- Collaborate with cross-functional teams to drive strategic decision-making in clinical development programs.
- Ensure compliance with ICH guidelines, FDA regulations, and other relevant regulatory requirements.
- Contribute to the establishment and maintenance of policies, standards, and procedures for biostatistics and programming activities.
- Provide mentorship and guidance to junior statisticians.
- Develop statistical analysis sections of protocols, statistical analysis plans (SAP), TLF shells, clinical study reports (CSR), regulatory documents or scientific publications, generates or reviews study randomization, sample size/power estimations.
- Review CRF's to ensure analysis data items are included and appropriately captured.
- Review of data validation checks to ensure analysis variable cleaning expectations are included.
- Review of SDTM and/or ADaM programming specifications. Review of vendor data transfer specifications for that data will be included in SDTM.
- Oversee vendor management and ensure quality control in externally produced statistical deliverables, such as SAP, SDTM, TLFs Shells, final TLFs.
- Provides statistically sound scientific methodology experimental design and data analysis input to meet project objectives and FDA (and other regulatory agencies) statistical and data requirements in a clear, concise, complete, and transparent manner that provide influence on key development decisions.
JOB SPECIFICATIONS:
- Ph.D. degree in statistics and 10+ years of experience (or master's degree in relevant statistics field and 15+ years of clinical trial experience) in the pharmaceutical or biotech companies, or related experience or equivalent combination of training and experience.
- Experience in both early and late phase clinical development.
- Oncology experience preferred.
- Proven expertise in complex trial designs, including interim analyses, biomarker and surrogate endpoint evaluations, multiplicity control, and survival analyses.
- Experience in regulatory submissions and regulatory interactions.
- Strategic thinking capabilities with a proven track record of innovative problem-solving.
- Demonstrated ability to lead statistical teams and manage resources effectively for complex programs and submissions.
- Team player, with ability to work successfully across functions.
- Demonstrated written and excellent communication and interpersonal skills, with the ability to translate statistical concepts into layman's terms.
- Proficiency with statistical programming in SAS and/or R.
- Knowledgeable in CDISC standards, including SDTM, ADaM.
- Familiar with ICH guidelines, FDA, and other regulatory authority guidance.
The base range for a Senior Director is $269,000 - $310,000 per year. Individual pay may vary based on additional factors, including, and without limitation, job-related skills, experience, work location, and relevant education or training. Kura's compensation package also includes generous benefits, equity, and participation in an annual target bonus.
Kura's Values that are used for candidate selection and performance assessments:
- We work as one for patients
- We are goal-focused and deliver with excellence
- We are science-driven courageous innovators
- We strive to bring out the best in each other and ourselves
The Kura Package
- Career advancement/ development opportunities
- Competitive comp package
- Bonus
- 401K + Employer contributions
- Generous stock options
- ESPP Plan
- 20 days of PTO to start
- 18 Holidays (Including Summer & Winter Break)
- Generous Benefits Package with a variety of plans available with a substantial employer match
- Paid Paternity/Maternity Leave
- In-Office Catered lunches
- Home Office Setup
- Lifestyle Spending Stipend
- Commuter Stipend (Boston Office)
- Regular employee social activities, including happy hours, monthly birthday celebrations, Kura Koffee Talks, and much more!
Kura Oncology is a clinical-stage biopharmaceutical company discovering and developing personalized therapeutics for the treatment of blood cancers and solid tumors. The company's diverse pipeline consists of small molecules that target cancer signaling pathways where there is a strong scientific and clinical rationale to improve outcomes by identifying those patients most likely to benefit from treatment. Kura Oncology's approach to drug development is focused on rapidly translating novel science into life-saving medicines. Our goal is to help patients with cancer lead better, longer lives. Kura Oncology has offices in San Diego, California, and Boston, Massachusetts.
Kura's pipeline consists of three investigational drug candidates: ziftomenib, tipifarnib and KO-2806. Ziftomenib, a once-daily, oral drug candidate targeting the menin-KMT2A protein-protein interaction, has received Breakthrough Therapy Designation for the treatment of R/R NPM1-mutant acute myeloid leukemia (AML). Kura has completed enrollment in a Phase 2 registration-directed trial of ziftomenib in R/R NPM1-mutant AML (KOMET-001). The Company is also conducting a series of clinical trials to evaluate ziftomenib in combination with current standards of care in newly diagnosed and R/R NPM1-mutant and KMT2A-rearranged AML. Tipifarnib, a potent and selective farnesyl transferase inhibitor (FTI), is currently in a Phase 1/2 trial in combination with alpelisib for patients with PIK3CA-dependent head and neck squamous cell carcinoma (KURRENT-HN). Kura is also evaluating KO-2806, a next-generation FTI, in a Phase 1 dose-escalation trial as a monotherapy and in combination with targeted therapies (FIT-001). For additional information, please visit Kura's website atwww.kuraoncology.comand follow us onXandLinkedIn.
Kura Oncology is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, or veteran status.
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