Senior Director, Biostatistics

Job Summary:

This person will head the biostatistics function at Keros Therapeutics. The ideal candidate is a leader with a growth mindset. They are a good communicator, collaborative, self-motivated, and forward thinking. They will serve as the core internal statistical authority, doing heavy hands-on work at the program/study level while partnering closely with the Head of Biometrics to oversee consultants and CRO vendors. They will provide statistical guidance to ensure clinical programs and studies are optimally strategized, correctly designed, properly analyzed, and clearly presented to support decision making, communications, and regulatory submissions through a close collaboration with the key stakeholders.

Primary Responsibilities:

• Lead the biostatistics function, including managing current consultants, overseeing CRO vendors, and eventually recruiting, developing, and retaining top internal talent as the team scales
• Lead the development and delivery of statistical methodology, biostatistical subject matter expertise, and statistical tools/applications development to support the development and marketing of new medicines
• Partner with key stakeholders and functions including clinical data management to ensure the timely delivery of high-quality statistical support to clinical programs
• Collaborate with other functions to ensure that advanced statistical expertise is appropriately integrated into clinical decision-making
• Oversee the performance of project team members and consultants, ensuring a proper level of scientific rigor, effective team operation, and seamless cross-functional collaboration
• Participate in biometrics vendor selection, infrastructure development, process improvement, training, SOP development, and enhancing statistical technical expertise
• Ensure that biostatistical activities comply with CDISC, health authority regulations, ICH/GCP guidelines, and company SOPs
• Be accountable for statistical activities in support of IND/EOP2/BLA/MAA or other regulatory submissions and interactions
• Author relevant sections of regulatory submissions, documents, responses, and address comments by IRB/ECs
• Contribute to the planning, review, and finalization of abstracts and manuscripts for publications
• Serve as a key liaison in the clinical team and provide hands-on statistical inputs in protocols, data monitoring committee (DMC) charters, safety review committee (SRC) charters, clinical study reports (CSR), and other study-level documents
• Serve as the biostatistical lead on clinical development programs to support the team in designing trials and supporting data collection, analyses, and interpretation of efficacy, safety, and biomarker results
• Author and review the statistical analysis plan (SAP) for clinical trials and for integrated summaries of safety/effectiveness (ISS/ISE), and author or oversee the development of shells for tables, figures, and listings (TFLs)
• Define and review randomization procedures and produce randomization lists
• Review study Case Report Forms (CRFs), data management plans (DMPs), and other data management-related documentation to ensure that specific statistical requirements defined in the study protocol are met
• Collaborate with the cross-functional team to contribute to data algorithms, reports, and visualizations in support of data quality and insights generation through data validation and data review
• Directly oversee vendors and external consultants providing statistical, programming, and data management services, ensuring timely and quality delivery of services.

Qualifications:

• PhD (Strongly preferred) or MS in Statistics, Biostatistics, or equivalent.
• 10+ years of relevant statistical experience in the biotech, pharmaceutical, or CRO industry.
• 5+ years of experience managing people or leading functional teams, with a proven ability to manage external consultants and CRO vendors.
• Proven ability to work effectively with minimal structure, with the agility to determine when structure is needed and independently develop related procedures.
• Experience with a broad array of statistical approaches, with a demonstrated ability to evaluate, propose, and implement novel or creative approaches to support the acceleration of clinical programs and/or rare disease development.
• Previous experience working within the estimand framework is highly desirable.
• Experience serving as the statistical lead on late-phase clinical trials and comprehensive knowledge of global regulatory guidelines are required.
• Effective communication and strategic relationship-building skills, with the ability to convey complex biostatistical considerations to cross-functional stakeholders and ensure appropriate interpretation of team needs.
• Strong interdependent and analytical thinking skills, with the ability to manage multiple projects simultaneously, balance conflicting priorities, and remain flexible as priorities change.
• Proficiency in SAS programming and deep knowledge of relevant ICH Guidelines (proficiency in R is a strong plus).
• Demonstrated ability to promote collaboration and enhance a corporate culture of trust and respect.