Biostatistics Director

Crinetics is a pharmaceutical company based in San Diego, California, developing much-needed therapies for people with endocrine diseases and endocrine-related tumors. We were founded by a dedicated team of scientists with the simple belief that better therapies developed from rigorous innovation can lead to better lives. Our work continues to make a real difference in the lives of patients. We have a prolific discovery engine and a robust preclinical and clinical development pipeline. We are driven by science with a patient-centric and team-oriented culture. Crinetics is known for its inclusive workplace culture. We are also a dog-friendly workplace. This is an exciting time to join Crinetics as we shape our organization into the world’s premier fully-integrated endocrine company from discovery to patients. Join our team as we transform the lives of others.

Position Summary

The individual in this position will provide leadership, execution of biostatistics activities associated with drug development to ensure that development activities are consistently aligned with the priorities and objectives of the company. The individual will be responsible for overseeing all biostatistics activities for assigned projects or studies and management of consultants. The role reports to the Senior Director, Biostatistics, compound lead.

Essential Job Functions And Responsibilities

These may include but are not limited to:

• Lead biostatistics project/study with accountability of biostatistics deliverables, including biostatistics support of clinical development planning, clinical study designs, protocol writing, analysis planning/execution, wiring statistical analysis plan, reviewing clinical study report and table/figure/listings, statistical interpretations, and regulatory submissions
• Provide leadership and perform study data reviews during clinical studies to ensure that clinical studies are on the right course as planned with proper checking of assumptions used for statistical analyses
• Collaborate with cross functional peers to facilitate and optimize the product development and registration process to meet deliverables and timelines for statistical data analysis and reporting
• Manage biostatistics vendors, identify potential risks and resolve issues with CROs
• Participate in statistical and company initiatives that improve the harmonization and efficiency of drug development
• Write TLF shells for the assigned studies and collaborate with programmers to review outputs
• Participate in and contribute to data review, statistical reporting, and various submission related activities in regulatory submissions
• Provide sample-size calculations for assigned studies
• Management of study biostatistics consultants
• Assist non-routine projects as applicable in support of drug development activities
• Other duties as assigned
  
  

Required

Education and Experience:

• PhD with 15+ years of experience or M.S. with 20+ years of experience in statistics or equivalent, with at least 5 years of relevant experience in biotechnology or pharmaceutical industry
• Excellent interpersonal and communication skills in both written and verbal
• Extensive knowledge of GCP, ICH guidelines, FDA regulations
• Ability to examine issues from various perspectives and apply appropriate concepts to address situations
• Demonstrated experience in providing statistical input and direction into the design of clinical studies, data analytic approaches, interpretation of findings and crafting of key messages
• Knowledge of SAS and Sample Size software such as East, Pass or NQuery
• Sound understanding of CDISC data standards to support regulatory submissions
• Knowledge of clinical trial design and the application of statistical methods to analyze and interpret trial data
  
  

Physical Demands And Work Environment

Physical Activities: On a continuous basis, sit at desk for a long period of time; intermittently answer telephone and write or use a keyboard to communicate through written means. Some walking and lifting up to 25 lbs. may be required. The noise level in the work environment is typically low to moderate. The physical demands described above are representative of those that must be met by an employee to successfully perform the essential functions and responsibilities of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions and responsibilities.

Laboratory Activities (if applicable): Biology and chemical laboratory environment experience needed. Environmental health and safety requirements also apply.

Travel

You may be required to travel for up to 5% of your time.

The Anticipated Base Salary Range: $200,000 - $250,000

In addition to your base pay, our total rewards program consists of a discretionary annual target bonus, stock options, ESPP, and 401k match. We also provide top-notch health insurance plans for employees (and their families) to include medical, dental, vision and basic life insurance, 20 days of PTO, 10 paid holidays, and a winter company shutdown.

The final salary offered to a successful candidate will be dependent on several factors that may include but are not limited to the type and length of experience and education. Crinetics Pharmaceuticals is a multi-state employer, and this salary range may not reflect positions that work in other states. Your recruiter can share more about the specific salary range during the hiring process.

Equal Opportunity Employer

Crinetics is proud to be an Equal Opportunity Employer. We provide equal employment opportunities to all employees and employment applicants without regard to unlawful considerations of sex, sexual orientation, gender (including gender identity and/or expression), pregnancy, race, color, creed, national or ethnic origin, citizenship status, religion or similar philosophical beliefs, disability, marital and civil union status, age, genetic information, veteran status or any personal attribute or characteristic that is protected by applicable local, state or federal laws.

Vaccination Requirement

Following extensive monitoring, research, consideration of business implications, and advice from internal and external experts, Crinetics requires that all employees and contractors be fully vaccinated and have received the COVID-19 vaccines as a condition of employment. “Full vaccination” is defined as two weeks after both doses of a two-dose vaccine or two weeks since a single-dose vaccine has been administered. Anyone unable to be vaccinated, either because of a sincerely held religious belief or a medical condition or disability that prevents them from being vaccinated, can request a reasonable accommodation.