Part-Time Contract Biostatistics Lead (up to 20 hours/week)

At Keros, our mission is to deliver significant clinical benefit to a wide range of patients with disorders that are linked to dysfunctional signaling of the transforming growth factor-beta (TGF-ß) family of proteins. With a focus on developing differentiated product candidates that are designed to alter TGF-β signaling, we aim to target the pathways critical for the growth, repair and maintenance of blood cells and a number of tissues, including bone, skeletal muscle, adipose and heart tissue. We believe our product candidates have the potential to unlock the full therapeutic benefits of modulating the TGF-β superfamily and provide disease-modifying benefit to patients. Job Summary: Provide statistical leadership and expertise into clinical development plans, study concepts, protocols, statistical analysis plan and clinical study reports. Identify and manage needed additional statistical services as needed to meet program/study objectives. Primary Responsibilities: • Develop and implement statistical strategies and solutions to support all phases of clinical trials and decision making • Serve as the biostatistical lead on clinical development program to support the team to design and support study analyses, interpretation of efficacy, safety, and biomarker data • Apply innovative approaches to study design, analysis, data modelling and exploration, and presentation methodologies • Author relevant sections of regulatory submissions, documents and responses and participate in writing, review and finalization of abstracts and manuscripts for publication • Contribute to the development of study protocols, Clinical Study Reports by providing statistical input. • Author/review the statistical analysis plan. • Plan and perform statistical analysis (interim and/or final) in accordance with the study protocol and the statistical analysis plan. • 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. • Guide study teams to ensure appropriate data reviews are implemented to support study objectives. • Oversee vendors providing statistical, programming and data management services including ensuring timely and quality delivery of services. • Participate in process improvement, training, SOP development, enhancing statistical technical expertise. • Ensure that biostatistical activities comply with CDISC, health authority regulations, ICH/GCP guidelines and company SOPs. 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. Qualifications: • MS or PhD in Statistics, Biostatistics or equivalent • A minimum of 5 to 10 years of relevant statistical experience in pharmaceutical or CRO industry • 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 • Proficiency in SAS programming, knowledge of relevant ICH Guidelines. Proficiency in in R a plus • Experiences with 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. Recruitment & Staffing Agencies: Keros Therapeutics does not accept unsolicited resumes from any source other than the candidate directly. Any unsolicited submission by an agency to Keros is prohibited. Any resume submitted by an agency without a signed contract or expressed consent by a member of the Keros Therapeutics Human Resources Department, will be considered property of Keros Therapeutics, and no fee shall be owed with respect thereto. Apply tot his job