Job Opportunity

Associate Director, Biostatistics

Location: San Diego, California, United States of America
Department: Biometrics
Employment Type: Regular
Reference Number: R45

Job Description Summary

The Associate Director, Biostatistics 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 associate 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.

Your Responsibilities

  • 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

  • PhD or MS in statistics, biostatistics, or closely related discipline; a minimum of 5 (for PhD) or 8 (for MS) years of experience for Ph.D. and 8 years of 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

Salary Range: 
$181,000 - $210,000

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). 

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