Senior Director, Biostatistics

Spyre Infostructure Inc.; United States; Remote; USD 275,000 - 313,000; Full time

Job summary

An established industry player is seeking a Sr. Director of Biostatistics to lead the biometrics team and provide strategic input for clinical development programs. In this hands-on role, you will oversee statistical activities supporting clinical trials, author statistical sections of protocols, and manage biometrics vendors. You will also interact with Health Authorities globally and promote innovative statistical methods to enhance the success of clinical studies. This dynamic environment offers the chance to shape the culture of a growing company while contributing to the advancement of meaningful medicines. If you're passionate about biostatistics and thrive in collaborative settings, this opportunity is perfect for you.

Benefits

Unlimited PTO

Performance Bonus

Equity Grant Opportunities

Health Benefits

Retirement Benefits

Professional Development Opportunities

Company-wide Shutdowns

Qualifications

• PhD in Biostatistics or related field with 10-12 years of experience.
• Strong knowledge of statistical methodologies in clinical trials.

Responsibilities

• Lead the biometrics team and provide statistical input for clinical trials.
• Collaborate with cross-functional teams to ensure project deliverables.

Skills

Statistical Methodologies

Communication Skills

Interpersonal Skills

Problem-Solving

Team Collaboration

Education

PhD in Biostatistics

Tools

SAS

R

CDISC Standards

Job description

Spyre Therapeutics is a biotechnology company that aims to create next-generation inflammatory bowel disease (IBD) and other immune-mediated disease products by combining best-in-class antibody engineering, rational therapeutic combinations, and precision medicine approaches. Spyre’s pipeline includes extended half-life antibodies targeting α4β7, TL1A, and IL-23.

Role Summary:

The Sr. Director of Biostatistics will provide leadership and strategic input for clinical development programs assigned. The selected individual will be responsible for statistical activities supporting clinical trials, including contributing to trial designs, authoring statistical sections of protocols, preparing statistical analysis plans, and reviewing and interpreting the analysis of clinical trial data. This is a hands-on role where you will interact with internal and external cross-functional study teams, support interactions with Health Authorities globally, conduct ad-hoc analyses, and manage biometrics vendors in preparing analysis files, performing statistical analyses, and delivering analysis results and data files.

Key Responsibilities:

• Lead the biometrics team including statistician, data manager, and statistical programmer at a program level.
• Provide statistical input to strategic planning, study design, protocol development, sample size calculation, CRF, Results Interpretation, clinical study report, and address questions from regulatory agencies.
• Promote research of advanced and innovative statistical methods to increase probability of success of clinical studies.
• Author and develop SAPs, and work with extended team or vendor in developing specification for derived variables, templates of statistical tables, figures, and listings.
• Provide guidance to study team on all aspects of statistical activities; collaborate closely with data manager to ensure high-quality data.
• Participate in cross-functional study-related activities; Work collaboratively with Clinical Development, Clinical Operations, Clinical Data Managers, Pharmacovigilance & Epidemiology, Regulatory, Project Management, Translational Medicine, and other staff and vendors to meet project deliverables and timelines.
• CRO / Vendor Oversight: Establish procedures through regular interaction, setting expectations on deliverables and timelines. Ensure deliverables are accurate and delivered according to timelines.
• Global Health Authority Interaction: Contribute to documents submitted to Health Authorities globally by providing input for the interaction or by writing the interaction document. May participate in meetings or teleconferences with Health Authorities.
• Coordinate with internal and external team members to prepare the statistical analyses for IB, DSUR updates, periodic safety updates, and other ad hoc analyses.
• Build and develop efficient biostatistical processes and standards.
• Other duties as assigned.

Ideal Candidate:

• PhD Degree in Biostatistics, Statistics, or a related field with at least 10-12 years of experience in biostatistics within the pharmaceutical, biotech, or CRO industry.
• Strong knowledge of statistical methodologies and their application in clinical trials and health research.
• Experience with regulatory submissions and interactions with regulatory agencies.
• Proficiency in statistical software (e.g., SAS, R) and data management systems.
• Experience with CDSIC including SDTM, ADaM, CDASH.
• Successful track record of working independently in a matrixed organization and providing solutions to emerging problems.
• Excellent communication and interpersonal skills, along with organizational skills.
• Ability to work collaboratively in a multidisciplinary team environment.

What We Offer:

• Opportunity to work in a fast-paced, dynamic environment where you help shape the culture of our young company, contribute broadly to advance meaningful medicines, 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 provide professional development opportunities.
• Remote working environment with frequent in-person meetings to address complex problems and build relationships.

The expected salary range offer for this role is $275,000 to $313,000. 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.