This person will be heading the biostatistics function at Keros Therapeutics. The ideal candidate is a leader with a growth mindset. They are good communicator, collaborative, self-motivated, and forward thinking. They will do hands-on work at program/study level as needed while also lead and mentor their team members on other programs/studies. 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.

Responsibilities:

• Lead the biostatistics team, including recruiting, developing, and retaining top talent
• Lead the development and delivery of statistical methodology, biostatistical subject matter expertise, statistical tools/applications development to support the development and marketing of new medicines
• Partner with key stakeholders/functions to ensure the timely delivery of high-quality statistical support to clinical programs
• Collaborate with other R&D functions to ensure that advanced statistical expertise is appropriately integrated into clinical decision-making
• Oversees the performance of project team members, ensuring proper level of scientific rigor, effective team operation and 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/interactions
• Author relevant sections of regulatory submissions, documents, responses and address comments by IRB/ECs
• Contribute to plan, review and finalization of abstracts and manuscripts for publications
• Be a key liaison in the clinical team and provide statistical inputs in protocols, data monitoring committee (DMC) charters, safety review committee charter (SRC), clinical study reports (CSR) and other study-level documents
• Serve as the biostatistical lead on clinical development program to support the team to design and support data collection, analyses, interpretation of efficacy, safety, and biomarker results
• Author/review the statistical analysis plan for clinical trials and for integrated summaries of safety/effectiveness (ISS/ISE), and authors or oversees the development of shells for tables, figures and listings
• Define/review the randomization procedures and producing randomization lists
• Review study Case Report Forms, data management plan and other data management related documentation to ensure that specific statistical requirements defined in the study protocol are met.
• Collaborate with 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, respectively
• Oversee vendors providing statistical, programming and data management services including ensuring timely and quality delivery of services.

Attributes:

• Ability to evaluate, propose and implement creative approaches.
• Ability to work effectively with minimal structure as well as determine when structure is needed and develop related procedures.
• Effective communication skills to convey biostatistical considerations and to ensure appropriate interpretation of team needs.
• Able to manage multiple projects simultaneously, to manage conflicting priorities, and to be flexible when priorities change.
• Ability to promote collaboration and enhance a culture of trust and respect

Qualifications

• PhD (Strongly preferred) or MS in Statistics, Biostatistics or equivalent
• 10+ years of relevant statistical experience in biotech, pharmaceutical or CRO industry
• 5+ years people management experience required
• Experience with a broad array of statistical approaches and able to propose novel approaches to support acceleration of clinical programs and/or new approaches for rare disease development. Previous experience in the estimand framework is highly desirable
• Proficiency in SAS programming, knowledge of relevant ICH Guidelines. Proficiency in in R a plus
• Experiences with late phase clinical trials and knowledge of regulatory guidance are required
• Experience managing vendors
• Other important requirements include interdependent/analytic thinking skills, building strategic working relationships, and good decision-making capability