Director/Senior Director, Biostatistics - Keros Therapeutics
Lexington, MA
About the Job
Keros Therapeutics is a public, clinical-stage biopharmaceutical company focused on the discovery, development, and commercialization of novel treatments for patients suffering from hematological and musculoskeletal disorders with high unmet medical need. We are a leader in understanding the role of the transforming growth factor-beta, or TGF-ß, family of proteins, which are master regulators of red blood cell and platelet production as well as of the growth, repair and maintenance of muscle and bone. We have leveraged this understanding and developed a discovery approach to generate large and small molecules to address diseases of these tissues. Targeting TGF-ß signaling pathways has been clinically proven to elicit robust changes in blood cells, muscle, and bone, which we believe provides a precedent and strong rationale for our strategy.
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
Our Diversity, Equity & Inclusion Mission Statement: Keros is an inclusive company. We believe that diversity drives innovation. We continue to build an inclusive culture that encourages, supports, and celebrates the diverse voices of our employees. As such, Keros takes a holistic approach in mentoring, coaching, and developing all of our Keros team members.
Keros Therapeutics is an Equal Opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex including sexual orientation and gender identity, national origin, disability, protected veteran status, or any other characteristic protected by applicable federal, state, or local law.