Senior Director, Biostatistics
About The Position
The Senior Director, Biostatistics will head the biostatistics function at Keros Therapeutics. This hands-on leader will serve as the company’s core internal statistical authority, contributing at the program and study level while partnering closely with the Head of Biometrics to oversee consultants and CRO vendors. The role provides statistical guidance so clinical programs and studies are strategically planned, appropriately designed and analyzed, and clearly presented to support decision-making, communications, and regulatory submissions. The position also includes building and developing the internal team as the function scales. The successful candidate will provide statistical methodology and subject matter expertise across clinical development, collaborate with stakeholders and functions including clinical data management, and integrate advanced statistical expertise into clinical decisions. They will lead statistical work for clinical development programs and regulatory submissions, contribute to study documentation and publications, and oversee external statistical, programming, and data management services. Biostatistical activities must comply with CDISC, health authority regulations, ICH/GCP guidelines, and company SOPs.
Requirements
- PhD in Statistics, Biostatistics, or equivalent is strongly preferred; MS in Statistics, Biostatistics, or equivalent is also accepted.
- At least 10 years of relevant statistical experience in the biotech, pharmaceutical, or CRO industry.
- At least 5 years of experience managing people or leading functional teams, including the ability to manage external consultants and CRO vendors.
- Ability to work effectively with minimal structure, determine when structure is needed, and independently develop related procedures.
- Experience with a broad range of statistical approaches and the ability to evaluate, propose, and implement novel or creative approaches to accelerate clinical programs and/or rare disease development.
- Experience serving as the statistical lead on late-phase clinical trials.
- Comprehensive knowledge of global regulatory guidelines.
- Effective communication and strategic relationship-building skills, including the ability to explain complex biostatistical considerations to cross-functional stakeholders and ensure appropriate interpretation of team needs.
- Strong interdependent and analytical thinking skills; ability to manage multiple projects, balance competing priorities, and adapt as priorities change.
- Proficiency in SAS programming and deep knowledge of relevant ICH guidelines.
- Ability to promote collaboration and foster a corporate culture of trust and respect.
Nice To Haves
- Previous experience working within the estimand framework.
- Proficiency in R.
Responsibilities
- Lead the biostatistics function, including managing consultants and CRO vendors and, as the team grows, recruiting, developing, and retaining internal talent.
- Lead the development and delivery of statistical methodology, biostatistical subject matter expertise, and statistical tools and applications to support the development and marketing of new medicines.
- Partner with key stakeholders and functions, including clinical data management, to provide timely, high-quality statistical support to clinical programs.
- Collaborate with other functions to integrate advanced statistical expertise into clinical decision-making.
- Oversee project team members and consultants to ensure scientific rigor, effective team operation, and cross-functional collaboration.
- Participate in biometrics vendor selection, infrastructure development, process improvement, training, SOP development, and enhancement of statistical technical expertise.
- Ensure biostatistical activities comply with CDISC, health authority regulations, ICH/GCP guidelines, and company SOPs.
- Be accountable for statistical activities supporting IND, EOP2, BLA, MAA, and other regulatory submissions and interactions.
- Author relevant sections of regulatory submissions, documents, and responses, and address comments from IRBs and ECs.
- Contribute to the planning, review, and finalization of abstracts and manuscripts for publication.
- Serve as a key liaison on the clinical team and provide hands-on statistical input for protocols, DMC and SRC charters, CSRs, and other study-level documents.
- Lead biostatistics for clinical development programs, supporting trial design, data collection, and the analysis and interpretation of efficacy, safety, and biomarker results.
- Author and review SAPs for clinical trials and integrated summaries of safety and effectiveness (ISS/ISE), and author or oversee development of TFL shells.
- Define and review randomization procedures and produce randomization lists.
- Review study CRFs, DMPs, and other data management documentation to ensure protocol-defined statistical requirements are met.
- Collaborate with cross-functional teams on data algorithms, reports, and visualizations that support data quality and insight generation through data validation and review.
- Directly oversee vendors and external consultants providing statistical, programming, and data management services, ensuring timely, high-quality delivery.
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What This Job Offers
Job Type
Full-time
Career Level
Senior
