Director Biostatistics (Medical Affairs, HEOR, RWE)
Employment Type: Full Time
Reference Number: 1710163
Job Description Summary
The Director of Biostatistics (Medical Affairs, HEOR, RWE) will provide statistical expertise to support Medical Affairs, Health Economics and Outcomes Research, and Real World Evidence generation. Responsibilities includes recommendation of study design, endpoint selection, perform statistical analysis, provide input to proposed protocol concepts, contribute to publication development and reviews, and participate in working groups across clinical development through commercialization. In this role, the director ensures all aspects of the projects meet the statistical rigors and standards, regulatory requirements, and quality deliverables are met and are aligned with clinical development and commercialization goals. The director will oversee external vendors and interprets/presents the analysis results in easily understandable terms to non-statistical audience.
- Provide statistical expertise to Medical Affairs and HEOR to ensure appropriate statistical principles are applied and the interpretation of the results are statistically valid
- Partner with team members from Biometrics, Clinical Development, HEOR/RWE, Medical affairs to achieve team project goals
- Provide statistical input to study concepts and proposals from investigators (Investigator Sponsor Trials) and ensure strategic alignment with the product lifecycle
- Participate in the publication planning and perform exploratory analysis in support of the publication plans
- Partner with external vendors and/or independently perform statistical modeling and analysis of patient reported outcomes data using accepted statistical methodologies and/or other advanced statistical approaches in support of value demonstration to patients and other stakeholders
- Review and provide statistical input to protocols, reports, value/reimbursement dossiers, and other ad hoc data requests
- Partner with cross functional team to develop and implement an effective plan to leverage RWE, where applicable
- In collaboration with team members, select vendors to assist on projects for Medical Affairs and HEOR/RWE as necessary
- Manage vendors by providing proper oversight to ensure quality deliverables and on-time delivery
- Provide computational and statistical advice on complex analytic issues supporting RWE projects and be able to work in an autonomous manner; participate in disease specific RWE meetings as needed
What is Required
- Ph.D. in statistics, biostatistics, or closely related discipline; a minimum of 8 years of experience (MS with a minimum 10 years experience) working in Medical Affairs, HEOR, and/or RWE
- Oncology experience preferred
- Strong programming skills in SAS and/or R and other statistical analysis software
- Experienced in statistical modeling and simulations
- Experienced with advanced inferential statistics (including and not limited to longitudinal data analysis, missing data methods, cost-effectiveness analysis, meta-analysis, Bayesian methods), real-world data analysis methods such as propensity scores, machine learning, and related techniques
- Prior exposure working with value/reimbursement dossiers and interactions with regulatory agencies or HTAs, a plus
- Demonstrated leadership experiences including the ability to influence and collaborate with peers
- Able to manage multiple, complex projects with tight timelines
- Excellent communication and collaboration skills; able to explain complex statistical concepts in layman's terms
About Mirati Therapeutics
Mirati Therapeutics is a late-stage biotechnology company whose mission is to discover, design and deliver breakthrough therapies to transform the lives of patients with cancer and their loved ones. The company is relentlessly focused on bringing forward therapies that address areas of high unmet need, including lung cancer, and advancing a pipeline of novel therapeutics targeting the genetic and immunological drivers of cancer. Mirati is using its scientific expertise to develop novel solutions in two registration-enabling programs: adagrasib (MRTX849), an investigational small molecule, potent and selective KRAS G12C inhibitor, as monotherapy and in combination with other agents, and sitravatinib, an investigational spectrum-selective inhibitor of receptor tyrosine kinases in combination with checkpoint inhibitor therapies. Mirati is also advancing its differentiated preclinical portfolio, including MRTX1133, an investigational KRAS G12D inhibitor, and other oncology discovery programs. Unified for patients, Mirati's vision is to unlock the science behind the promise of a life beyond cancer.
At Mirati, we have an unapologetic and relentless focus on our mission to transform the lives of patients with cancer and their loved ones. Patients and their families motivate us to work smarter, faster and better. We are driven by the knowledge that our efforts can one-day deliver life-saving therapies for the people who need us most. Urgency, open-mindedness, accountability and collaboration ground our work. These shared values are central to who we are, what we do and how we do it.
Our people fuel our success. They are fearless and passionate in their daily pursuit of our mission. We are committed to continuing to create a company and experience that attracts and keeps the best people. When you want your days to count and the work you do to matter, discovering and delivering potentially life-changing therapies is more than a job, it's the chance to be part of something bigger.
We believe diverse professional experiences and an inclusive culture can drive better outcomes for patients. We want employees to be authentic and use their perspectives to contribute to our mission in a meaningful way.
Mirati cultivates an environment where:
- An entrepreneurial attitude is encouraged
- Our people are empowered to speak up, embrace the gray and achieve solutions
- Diverse experiences are an important of part making the best decisions
- We laugh and have fun as a work family
No matter the role, we are unified by our passion for helping patients, and are inspired by a single vision to unlock the science behind the promise of a life beyond cancer. Together, we own Mirati's success.
Learn more at Mirati.com/careers.
Mirati is an Equal Opportunity Employer (EOE) we celebrate diverse experiences without regard to race, color, religion, creed, gender identity or expression, age, national origin or ancestry, citizenship, disability, sexual orientation, marital status, pregnancy, veteran status, membership in the uniformed services, genetic information, or any other basis protected by applicable law.
Notice to Third Party Agencies: Please note that Mirati Therapeutics Inc. does not accept unsolicited resumes from recruiters or employment agencies.