Employment Type: Full Time
Reference Number: 1708226
Job Description Summary
The Director, Biostatistics is responsible for providing technical leadership through the use of novel innovative designs; a key contributor to the clinical development plans; may lead a team of biostatisticians; evaluate, analyze, and interpret the clinical study results and ensure statistical integrity; experienced in regulatory submissions to the FDA and other regulatory agencies.
- Demonstrates effective contributor in working with other functional team members in the clinical development plan
- Leads Biostatistics function at cross-functional meetings; collaboratively within biometrics teams and with cross-functional teams to meet product deliverables and timelines for statistical data analysis and reporting
- Validate the results of key statistical deliverables, including topline TFL, perform ad hoc and exploratory statistical analyses
- Conduct independent statistical modeling and simulation or in collaboration with other team members to assist drug development strategy
- Experienced in leading submission related activities; represents department in meetings at regulatory agencies
- Support publications effort including manuscripts, conference presentations and posters
- Proven track record to independently lead a team of biostatisticians in the evaluation and implementation of novel clinical trial designs
- Experience in leading vendor (CRO) selection; oversight of vendors to ensure timeliness and quality of analysis and statistical outputs
- Leads department processes and standards and trains junior department personnel as necessary to achieve department objectives
What is Required
- A PhD in statistics, biostatistics or related field with minimum of 8 years clinical trial experience in the pharmaceutical or Biotech Companies, or MS degree with minimum of 10 years of experience; oncology experience preferred
- Advanced knowledge of statistical methods in clinical study designs (adaptive, Bayesian), statistical analysis methods including survival analysis, Bayesian method, missing data imputation, multiplicity adjustment
- Demonstrated written and excellent communication and interpersonal skills, with the ability to translate statistical concept into layman's term
- Demonstrated leadership skills
- Proficiency with statistical programming in SAS and/or R, and other statistical software such as EAST
- Knowledgeable in CDISC standard including SDTM, ADaM
- Familiar with ICH guideline, FDA / EMA / other regulatory authority guidance
- BLA/NDA experience including eCTD submission
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 KRASG12C 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 KRASG12D 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.