Associate Director, Biostatistician 2020-132

Location
San Diego, CA, United States
Posted
Sep 03, 2020
Ref
1477715
Hotbed
Biotech Beach
Required Education
Doctorate/PHD/MD
Position Type
Full time
Mirati Therapeutics (NASDAQ: MRTX) is a San Diego-based clinical-stage biotechnology company dedicated to advancing novel therapeutics that extend the lives of patients by directly addressing the genetic and immunological drivers of cancer. Mirati is developing sitravatinib, designed to selectively target a spectrum of tyrosine kinases implicated in both tumor growth and the suppression of immune responses to tumors. Sitravatinib has demonstrated durable responses in lung cancer patients whose cancer has progressed despite treatment with checkpoint inhibitors - an area of significant unmet medical need. Sitravatinib is being evaluated in multiple clinical trials to treat patients who are refractory to prior immune checkpoint inhibitor therapy, including a potentially registration-enabling Phase 3 trial of sitravatinib in combination with a checkpoint inhibitor in non-small cell lung cancer (NSCLC) that is currently enrolling patients.

Mirati is also developing novel direct inhibitors of KRAS mutations including MRTX849, a potent and selective inhibitor of KRAS G12C. This historically difficult to drug target is present in approximately 14% of NSCLC adenocarcinomas, 4% of colorectal cancer as well as smaller percentages of several other difficult-to-treat cancers. MRTX849 is being evaluated in a Phase 1/2 clinical trial as a treatment for patients with KRAS G12C-positive tumors. Our research on G12C has led to breakthroughs in targeting other KRAS mutations including G12D which drives tumor growth in more patients than G12C and includes pancreatic, colorectal and other types of cancer.

We are Mirati: Our mission is to discover, design, and deliver breakthrough therapies to transform the lives of cancer patients and their loved ones. We have built a culture fueled by accountability, urgency, collaboration and open-mindedness, and have established ourselves as an innovator within our industry. As we grow, we are looking to build diverse teams, with skilled individuals that are passionate about their work.

Why join us? The Associate Director of Biostatistics is responsible for providing statistical expertise and leadership for clinical pharmacology programs and/or clinical studies leading to regulatory submissions. This individual will work with cross-functional teams of the organization by providing strategic study design recommendations (clinical pharmacology and/or clinical), consultation on protocols, all aspects of study implementation and analysis, and ensure adherence to statistical integrity.

Your Responsibilities:
  • Represents Biostatistics function at cross-functional meetings on clinical pharmacology studies; may also contribute to non-pharmacology clinical studies using appropriate statistical principles
  • Collaborate within biometrics teams and with cross-functional teams to meet product deliverables and timelines for statistical data analysis and reporting
  • Lead the effort in the selection of CROs (vendors) for outsourcing of statistical activities related to clinical pharmacology and/or clinical studies
  • Oversight of vendors to ensure timeliness and quality of analysis and statistical outputs
  • Collaborate with the selected CROs and validate the results of key statistical deliverables; perform ad hoc statistical analyses
  • Conduct independent statistical modeling and simulation or in collaboration with other team members to assist drug development strategy
  • May perform submission related activities
  • May represent department in meetings with regulatory agencies
  • Support publications effort including manuscripts, conference presentations and posters
  • Develops department processes and standards and trains junior department personnel as necessary in order to achieve department objectives

What is Required:
  • A PhD in statistics, biostatistics or related field with minimum of 6 years clinical trial experience in the pharmaceutical or Biotech Companies, or MS degree with minimum of 8 years of experience; minimum 4 years of experience in clinical pharmacology studies in oncology
  • Familiar with clinical pharmacology studies including but not limited to BA/BE, DDI, TQT study, renal/hepatic impairment study
  • Knowledgeable in statistical methods used in the clinical pharmacology studies and clinical study designs including pharmacokinetics (PK), population PK modeling, Bayesian methods, missing data imputation
  • 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
  • Knowledgeable in CDISC standard including SDTM, ADaM
  • Familiar with ICH guideline, FDA / EMA / other regulatory authority guidance
  • Preferably BLA/NDA experience including eCTD submission

Mirati's policy is to provide equal employment opportunities to all applicants and employees without regards 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 informations, 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.