Job Opportunity

The ideal candidate will have diverse Biostatistics, Programming and Data Management senior leadership experiences and serve as a hands-on leader driven to direct and contribute broadly to Mirati Biostats and DM functional initiatives. The leader will be responsible for the management and ongoing development of the supporting biostatistics, programming and data management teams and performance as well as actively participate in the development, implementation, and oversight of clinical programs. Experiences in all phases of clinical trials and real-world data preferred given we have an approved drug and a rich pipeline.

Your Responsibilities

• Leads the biostatistics, data management and statistical programming functions to support design and analysis of clinical trials (including FIH and registrational studies) in pursuit of dose-finding, proof-of-concept, regulatory approval and marketing efforts

• Oversees the design, development, and implementation of innovative biostatistics, data management and Statistical Analysis Systems (SAS) programming workflows and provides technical leadership, development, and supervision of a multidisciplinary team 

• Strategic partner working closely with Clinical, Regulatory, Operations, and other functions in support of the design and execution of clinical trials and regulatory submissions

• Represents biostatistics function in interactions with Health Authorities, institutional review boards, and internal executive leadership

• Responsible for the overall quality of all Statistics /SAS programming/Data Management design, analysis and reporting deliverables 

• Develops and implements the vision to support research & development, clinical data management and analysis 

• Directs the design, development, modification and evaluation of a technical infrastructure to expedite the management, evaluation and reporting of clinical trials data 

• Manages the design and monitors processes for clinical data management and reporting 

• Manages the design, monitors the statistical analysis and develops tracking systems to determine the efficiency of clinical trials Manages the evaluation and design of clinical data statistics 

• Responsible for leading the biometrics department teams in ensuring effective, timely, high quality and compliance management and delivery of goals and accountabilities of multiple ongoing projects

• Ensures all department work is performed consistent with Good Clinical Practices (GCP) 

What is Required

Qualifications:

• PhD in (bio) statistics or related field, an equivalent combination of relevant education and applicable job experience may be considered 

• Minimum of 15 years progressively responsible experience in clinical research with a focus on biometrics disciplines and 10 years in a leadership role, preferably with significant oncology industry experience 

• Experience includes managing data management, biostatistics and SAS programing professionals on clinical trials that have delivered the agreed-upon end products on time. Biopharmaceutical industry experience required 

• Solid knowledge of data management, statistical and SAS programming processes and technologies. 

• Thorough experience with the drug development process and execution on biometrics  

• Excellent interpersonal communication and networking skills with the ability to build cross functional bridges 

• Established track record in delivering biometrics components of clinical projects and regulatory submissions   

Pay Disclosure

Salary Range:

$311,201 – $501,470

The salary range listed in the job posting reflects the anticipated base pay range for this role in the United States. Actual base pay decisions consider a variety of factors including, but not limited to, an individual’s skills, qualifications, and experience. In addition to a competitive base salary, this role is currently eligible for our annual discretionary bonus program and annual equity awards (roles on a sales-incentive commission plan will not be eligible for our annual discretionary bonus).

Total Rewards

Mirati employees (and their families) are provided a competitive benefits package including:

• Comprehensive healthcare coverage – multiple medical plan choices with an employer-funded HSA, dental & vision

• Company provided life insurance and disability coverage

• 401(k) retirement plan with a 6% company match and immediate vesting

• Employee Stock Purchase Plan with a 15% discount

• Extensive time off – holidays, PTO and two, week-long paid breaks in the summer and winter