Abata Therapeutics

Associate Director / Director, Biostatistics

Remote

Not SpecifiedCompensation
Senior (5 to 8 years), Expert & Leadership (9+ years)Experience Level
Full TimeJob Type
UnknownVisa
Biotechnology, Pharmaceuticals, HealthcareIndustries

About Us

Dianthus Therapeutics is a publicly traded, clinical-stage biotechnology company dedicated to designing and delivering novel, best-in-class monoclonal antibodies with improved selectivity and potency. Based in New York City and Waltham, Mass., Dianthus is comprised of an experienced team of biotech and pharma executives who are leading the development of next-generation antibody complement therapeutics, aiming to deliver transformative medicines for people living with severe autoimmune and inflammatory diseases.

About the Role

As the Associate Director or Director, Biostatistics you will lead critical statistical activities across one of our phase III clinical programs. Reporting to the Head of Biostatistics, you will provide strategic and technical leadership in the design, analysis, and interpretation of clinical trials in a dynamic, fast-paced organization. You will collaborate cross-functionally with Clinical Development, Clinical Operations, Regulatory, Data Management, Medical Writing, and external vendors to ensure the delivery of high-quality and compliant statistical deliverables. This is an exciting opportunity to join a growing team with ongoing phase III development and multiple streams of regulatory agency interactions. This role has direct visibility across Dianthus Therapeutics, including to senior leadership. We are building a culture of individuals who hold our core principles at the center of our operations, with the goal to elevate the care of our patients’ lives. We are open to you working remotely.

Key Responsibilities

  • Serve as the lead biostatistician for one or more clinical programs or trials from Phase I through Phase III.
  • Provide strategic input into clinical development plans, study designs, and statistical methodologies; present statistical aspects of development planning to internal stakeholders.
  • Develop or review statistical sections of clinical trial protocols, SAPs (Statistical Analysis Plans), and other key study documents.
  • Collaborate with internal teams and CROs to oversee statistical programming, analysis, and validation of results.
  • Interpret and communicate statistical results to clinical and regulatory stakeholders.
  • Contribute to regulatory submissions including ISS/ISE, briefing books and responses to health authority questions; attend meetings with regulatory agencies.
  • Ensure statistical deliverables comply with regulatory requirements (e.g., FDA, EMA, ICH).
  • Identify opportunities for process improvements and implement innovative statistical solutions.
  • Represent Biostatistics in cross-functional project teams and contribute to decision-making.

Experience

  • Ph.D. or M.S. in Biostatistics, Statistics, or related field.
  • Must have experience in the Biotech/Pharma Industry or CRO.
  • Hands-on experience leading statistical activities for clinical trials across multiple phases.
  • Expertise in clinical trial methodology, adaptive designs, and regulatory guidance.
  • Proficiency in SAS, including with data simulation and analysis; familiarity with CDISC standards (SDTM/ADaM).
  • Experience with regulatory submissions and interactions (NDA/BLA/MAA) strongly preferred.
  • Strong communication and interpersonal skills, with the ability to explain statistical concepts to non-statisticians.
  • Demonstrated ability to work independently and thrive in a fast-paced, start-up environment.

Skills

Biostatistics
Clinical Trials
Statistical Analysis
Study Design
Regulatory Affairs
Data Management
Medical Writing
Leadership

Abata Therapeutics

Develops therapies for autoimmune diseases

About Abata Therapeutics

Abata Therapeutics develops therapies for autoimmune diseases, focusing on type 1 diabetes. Their main product, ABA 201, is a Treg cell therapy aimed at patients with some remaining beta cell function. This therapy works by utilizing regulatory T cells to improve patient outcomes. Unlike many competitors, Abata targets a specific niche within the autoimmune disease market and collaborates with partners like ElevateBio for process development and manufacturing. The company's goal is to transform treatment options for autoimmune diseases through advanced research and development.

Cambridge, MassachusettsHeadquarters
2021Year Founded
$184.8MTotal Funding
EARLY_VCCompany Stage
BiotechnologyIndustries
11-50Employees

Risks

Intensifying competition from companies like Sangamo Therapeutics may impact Abata's market share.
Stringent FDA scrutiny on manufacturing could delay Abata's clinical trials.
Rising clinical trial costs pose financial risks to Abata's pipeline progression.

Differentiation

Abata focuses on Treg cell therapies for autoimmune diseases like MS and diabetes.
Their lead product, ABA 201, targets type 1 diabetes with remaining beta cell function.
Abata's strategic partnership with ElevateBio enhances their manufacturing capabilities.

Upsides

Recent investment from Bristol Myers Squibb boosts Abata's Treg therapy pipeline development.
FDA's accelerated approval pathways may expedite Abata's clinical trials.
Growing autoimmune disease prevalence increases demand for Abata's innovative treatments.

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