Who We Are
Kinnate Biopharma Inc. is a clinical-stage precision oncology company focused on expanding on the promise of targeted therapies for those battling cancer.
The company is developing medicines for known oncogenic drivers where there are no approved targeted drugs and to overcome the limitations of marketed cancer therapies, such non-responsiveness or acquired and intrinsic resistance.
Kinnate has two lead clinical programs being studied in solid tumors with RAF, NRAS and FGFR-driven alterations, and is rapidly progressing a pipeline of additional small molecule drug candidates as part of the Kinnate Discovery Engine.
The company is driven by the urgency and knowledge that patients are waiting for new, effective cancer medicines. Come join us to help improve lives.
For more information, visit www.kinnate.com and follow us on LinkedIn.
Your Impact at Kinnate
The Biometrics Department provides a wide range of services for quantitative research including study design, data management, consultation, training, data analysis, documentation, regulatory compliance, and reporting and dissemination. The position will report to the Head of Biometrics.
Responsibilities:
The Director of Biostatistics will serve as an instrumental role to drive innovative and efficient study design. Develop study designs that address study objectives that will facilitate medical research and regulatory approval.
· Independently lead, initiate, and oversee the statistical support for the development of compounds within a therapeutic area
· Lead assessment and introduction of novel statistical methodologies to implement solutions
· Partner with Statistical Programming in generation of statistical analyses for internal and external presentations, and validation of statistical analyses results generated in-house or by CROs.
· Effectively engage as a matrix team member on high level development teams, to act as a scientific and strategic partner in the drug development process.
· Spearhead development of statistical analyses plans, data presentation plans, clinical development plans, lead biometrics related submission activities, and post-submission strategies/ preparations/defenses.
· Contribute to creation/maintenance of and provide training on statistical topics departmental SOPs.
The Right Stuff
· PhD 7+ or MS (10+ years experience) in statistics or biostatistics or related scientific field with clinical trials, drug development, pharmaceutical industry or healthcare experience,
· Technical expertise and knowledge of experimental design and analyses using SAS, R, or EAST, Spotfire etc and implementation of advanced statistical analysis, data manipulation, graphing & simulation.
· Working knowledge of statistical programming languages and ability to code programs to analyze and report complex clinical trial data, as well as for electronic review, exchange, transformation, and submission of data in CDlSC, SDTM and ADaM formats
· Experience in organizing and driving regulatory submissions such as NDA, sNDA, and MAA submissions.
· Good working knowledge of ICH, FDA and GCP regulations and guidelines
· Detailed knowledge of adaptive designs, Bayesian methodology, trial simulation, and data modeling is strongly preferred
· Experience in preparing and participating in global regulatory agency interactions (Oncology experience preferred.)
· Excellent interpersonal, problem solving, communication and influence/negotiation skills
NOTE: This position summary is not intended to be all-inclusive. Employee may perform other related duties as negotiated to meet the ongoing needs of the organization.
We offer a competitive total rewards package that provide our employees with the resources to pursue their goals, both at work and in their personal lives. The salary reasonably expected to be paid for this role is $222,700 - $240,455. The actual compensation and seniority level for this position will be determined based on relevant experience and qualifications. This position is eligible for an annual cash bonus and equity awards. Our employees are also eligible to receive other benefits including:
· Unlimited Paid Time Off
· 11 Company Paid Holidays - plus 2 annual paid “Refresher Days”
· Wide variety of comprehensive health, dental, and vision packages – most with minimal to no out-of-pocket expenses for employees
· Company contribution to 401k plan
· Employee stock purchase program
· Annual Massage Days
· Free local gym memberships
· Healthy Lifestyle Reimbursement Program
· Home Office Reimbursement Program
Kinnate recognizes the importance of balance and flexibility in our work environment. Physical[PS3] presence at the Kinnate worksites or physical presence in the field is an essential job function of this role which the company deems critical to collaboration, innovation, productivity, employee well-being and engagement, and enhances the company culture.
Kinnate is proud to be responsible members of our communities. Subject to applicable law, we require all our employees to be fully vaccinated and boosted against the COVID-19 virus. Therefore, all applicants seeking a role located in the U.S. must confirm that they have already received or are willing to receive the full COVID-19 vaccination by their start date as a qualification of the role and condition of employment.
EEO & Employment Eligibility
Kinnate Biopharma Inc. is committed to building a diverse, equitable, and inclusive company. We provide equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Kinnate Biopharma Inc. also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of applicable law.