Overview
Tyra Biosciences, Inc. is seeking a highly motivated Associate Director or Director, Biostatistics to make impactful contributions to oncology and rare disease drug development programs targeting areas of high unmet medical need. The successful candidate will be highly organized, self-motivated, and thrive in a dynamic, cross-functional, start-up environment.
This role will drive the development and implementation of statistical strategies to support clinical development and will contribute to company success through robust study design, clear interpretability of results, effective regulatory support, and the application of innovative methodologies to enhance the efficiency and quality of clinical programs.
Job Responsibilities
- Provide statistical leadership for one or more clinical development programs from Phase 1 through Phase 3
- Lead the design of clinical trials, including protocol development, endpoint selection, and sample size determination, with consideration for small populations and pediatric study constraints
- Develop and implement innovative and efficient statistical methodologies tailored to rare disease and growth disorder studies, including adaptive and model-informed approaches
- Author and oversee statistical sections of key regulatory documents, including protocols, Statistical Analysis Plans (SAPs), Clinical Study Reports (CSRs), and regulatory briefing packages
- Ensure high-quality statistical deliverables, including tables, figures and listings (TFLs), and support interpretation of study results
- Serve as the primary statistical representative on cross-functional teams, collaborating closely with Clinical Development, Clinical Operations, Regulatory Affairs, and Data Management
- Provide strategic input on development plans, including extrapolation strategies, use of external or historical controls
- Oversee CROs and external vendors to ensure timely, high-quality execution of statistical analyses
- Support regulatory interactions with agencies such as the U.S. Food and Drug Administration
- Contribute to publications, scientific presentations, and external communications of clinical data
- Mentor and provide technical guidance to programmers
Work Experience and Educational Requirements:
- Ph.D. (strongly preferred) or M.S. in Statistics, Biostatistics, or a related field with 8+ years of relevant drug development experience
- Demonstrated experience in oncology, pediatrics, rare disease, or growth disorders strongly preferred
- Broad knowledge of statistical methodologies, with the ability to propose and implement novel approaches to accelerate clinical development and address challenges in rare disease settings
- Proficiency in SAS and/or R programming; strong knowledge of relevant ICH guidelines
- Experience managing CROs and external vendors
- Excellent written and verbal communication skills, with the ability to clearly convey complex statistical concepts
- Strong analytical thinking and strategic problem-solving skills
- Ability to work independently, manage multiple programs or studies, and adapt in a fast-paced environment
- Proven ability to lead within a line function and influence cross-functional teams in a matrixed, global organization
- Sound decision-making skills and the ability to navigate complex business and scientific challenges
- Ability to accommodate up to 20% travel or as business dictates
Pay Range and Benefits
Base Salary Range: $232,654 - $250,000USD (Dir Level), 205,852 - $226,271 (Assoc Dir Level)
Individual compensation will be determined based on factors such as work location, skills, education, training, and experience.
_What we offer US-based Empl_ oyees:
- Competitive base, bonus, new hire and ongoing equity packages
- The starting compensation range(s) for this role is for a full-time employee (FTE) basis
- Benefit offerings are subject to the terms and conditions of the applicable plans in effect at the time and may require enrollment
- Employer-paid Medical, dental, and vision insurance
- Employer-paid life insurance, AD&D, short-term disability, long-term disability, and EAP coverage
- 401(k) Plan with a fully vested company match 1:1 up to 4% of contributions
- Employee Stock Purchase Plan
- 14 -18 paid holidays, including office closure between December 25th and January 1st
- Flexible vacation
- Sick time
- Fitness Program
- Get Outdoors Program
- Paid parental leave benefit
- Tuition assi**stance**
Job Type: Full-Time
Work authorization : United States (Required)
Work Location: Remote
Equal Opportunity Employer: Tyra Biosciences, Inc. is an equal opportunity employer that is to providing a work environment free of harassment and discrimination based upon a protected category, as well as an environment free from retaliation for protected activity.
Notice to Recruiters and Third-Party Agencies: The Talent Acquisition team manages the recruitment and employment process for Tyra. To protect the interests of all parties involved, Tyra will only accept resumes from a recruiter once a fully-executed search agreement is in place. Agencies are hereby specifically directed not to contact Tyra employees directly in an attempt to present candidates. Tyra will consider any candidate for whom an Agency and/or Recruiter has submitted an unsolicited resume to have been referred, free of any charges or fees.
