PhD (preferred) or MS in Statistics, Biostatistics, or equivalent.
10+ years of statistical experience in biotech, pharmaceutical, or CRO industry.
5+ years of experience managing teams and external consultants.
Ability to work independently and develop procedures as needed.
Experience with diverse statistical approaches and novel methodologies.
Familiarity with the estimand framework is highly desirable.
Experience as a statistical lead on late-phase clinical trials with knowledge of global regulatory guidelines.
Strong communication and relationship-building skills for cross-functional collaboration.
Proficiency in SAS programming; R knowledge is a plus.
Responsibilities
Lead the biostatistics function and manage consultants and CRO vendors.
Develop and deliver statistical methodologies and tools for new medicine development.
Collaborate with stakeholders to ensure timely, high-quality statistical support.
Integrate advanced statistical expertise into clinical decision-making.
Oversee project team performance and ensure scientific rigor and collaboration.
Participate in vendor selection and process improvement initiatives.
Ensure compliance with CDISC, health authority regulations, and ICH/GCP guidelines.
Accountable for statistical activities in regulatory submissions and interactions.
Author regulatory submission sections and address feedback from IRB/ECs.
Contribute to planning and finalizing abstracts and manuscripts for publication.
Serve as a liaison in the clinical team, providing statistical input on study documents.
Lead biostatistical efforts in clinical development programs, supporting trial design and data analysis.
Author and review statistical analysis plans and develop TFL shells.
Define randomization procedures and review study documentation for statistical requirements.
Collaborate on data algorithms and visualizations to enhance data quality and insights.
Oversee vendors providing statistical and data management services.
Benefits
Comprehensive health insurance coverage.
Retirement savings plan with company match.
Generous paid time off and holiday schedule.
Professional development opportunities and training.
Flexible work arrangements to support work-life balance.
Full Job Description
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.
This pay range represents the base hourly rate or base annual full-time salary for all positions in the job grade within which this position falls. The actual base salary offer will depend on a variety of factors including experience, education, and other relevant factors.
