VP, Head of Biostatistics - Remote, United States - Spyre Therapeutics

Description

Spyre Therapeutics (NASDAQ: SYRE) is a biotechnology company aiming to address the needs of the millions of people living with inflammatory bowel disease (IBD) by advancing potentially best-in-class long-acting antibodies, rational therapeutic combinations, and precision immunology approaches. Spyre is advancing a robust portfolio that harnesses both proven and novel mechanisms of action for addressing IBD. The company's two parallel lead programs—SPY001 and SPY002—target ɑ4β7 and TL1A, respectively, and build upon the validation of these targets by existing commercial- and clinical-stage antibody therapeutics. The company's lead programs are projected to enter clinical studies in 2024.

Role Summary

The Vice President, Head of Biostatistics will play a pivotal role in leading our biostatistical efforts to advance the development of our cutting-edge antibody conjugate portfolio. This executive position requires a leader to set the strategic vision while providing the highest level of data management, modeling and statistic practices into our drug development programs to ensure efficacy, safety, and regulatory success.

Key Responsibilities

• Lead the strategic planning and execution of statistical and data management practices.
• Collaborate closely with cross-functional teams, including discovery, regulatory affairs, and clinical development, to ensure alignment and integration of statistical expertise into clinical development plans.
• Govern the development and implementation of statistical methodologies, study design, and data analysis.
• Oversee statistical aspects of clinical trials, including sample size determination, randomization, and statistical modeling.
• Provide expert guidance on statistical documentation for regulatory submissions and interactions with health authorities worldwide.
• Stay abreast of emerging trends and regulations in statistical analysis and antibody development to ensure Spyre Therapeutics remains at the cutting edge.
• Build the biostatistics team, develop and fostering a culture of excellence, collaboration, and continuous learning.
• Oversee external statistical consultants as needed.

Ideal Candidate

• Ph.D. in statistics, biostatistics, or related field, with a strong focus on biostatistics.
• A minimum of 10 years of experience in biostatistics within the pharmaceutical or biotechnology industry. Experience in immunology, monoclonal antibody development, or inflammatory bowel disease, is desirable.
• Proven track record of leadership in drug development, from early-stage research through to regulatory submission and approval.
• Extensive experience with regulatory submissions and interactions with health authorities, particularly the FDA and EMA.
• Strong analytical and problem-solving skills, with expert knowledge of clinical trial design, statistical methodologies, and regulatory guidelines.
• Excellent communication and interpersonal skills, with the ability to lead and motivate teams and collaborate effectively across functions.

What We Offer

• Opportunity to work in a fast-paced, highly dynamic environment where you help shape the culture of our young company, wear multiple hats, and learn quickly.
• Market-competitive compensation and benefits package, including base salary, performance bonus, equity grant opportunities, health, welfare & retirement benefits.
• Unlimited PTO
• Two, one-week company-wide shutdowns each year.
• Commitment to growing you professionally and providing access to resources to further your development.
• 100% remote team with frequent in-person meetings to build relationships and problem solve.
  

The expected salary range offer for this role is $322,000 to $380,000. Actual pay offered may vary depending on job related knowledge, experience, education, and geographic location.

As an equal opportunity employer, Spyre is committed to a diverse workforce. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, gender, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, or other non-job-related characteristics or other prohibited grounds specified in applicable federal, state and local laws. We also embrace differences in experience and background, and welcome diversity of opinions and thought with active recruitment designed to create a stronger and better Spyre that is focused on developing life-changing products for patients.

Spyre Therapeutics, along with other biotech companies, has become aware of a surge in email scams targeting prospective job candidates within our industry. Please be aware that official recruiters at Spyre Therapeutics only use email addresses with the domain "" We want to also emphasize that we never request candidates to make any purchases or divulge sensitive personal information via email.

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