Abata Therapeutics

Associate Director, Statistical Programming

Remote

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

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, Statistical Programming, you will lead statistical programming activities across our clinical development programs. Reporting to the Head of Biostatistics, you will be responsible for building internal capabilities and ensuring high-quality programming deliverables for regulatory and clinical milestones. You will work with key internal stakeholders, oversee vendors, perform CDISC compliance checks, program ad hoc datasets and TFL, and ensure regulatory acceptance of datasets. You must have experience within a Biotech, Pharma, or CRO and technical depth to work independently as the lead statistical programmer.

This is an exciting opportunity to join a growing team with ongoing phase III development as the first statistical programming team member, with the opportunity to build a programming infrastructure while directly collaborating with internal stakeholders to ensure the TFL meet company needs. 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

  • Lead the development, validation, and documentation of statistical programming deliverables (e.g., SDTM, ADaM datasets, tables, listings, and figures) for clinical studies and regulatory submissions.
  • Collaborate with internal teams and CRO partners to ensure quality, consistency, and compliance with CDISC standards and regulatory requirements.
  • Serve as the primary programming lead across multiple studies or clinical programs.
  • Develop and maintain programming standards, tools, and processes to support scalable clinical development.
  • Provide strategic input to study design, data flow, and database structures from a programming perspective.
  • Review and provide input on protocols, statistical analysis plans (SAPs), CRFs, and data specifications.
  • Support preparation of regulatory documents including clinical study reports (CSRs), ISS/ISE, and responses to health authority questions.
  • Partner with biostatistics, data management, medical writing, regulatory, clinical development, and clinical operations teams to ensure alignment of timelines and deliverables.
  • Contribute to vendor selection, oversight, and performance management related to programming activities.

Experience

  • Bachelor’s or Master’s degree in Computer Science, Statistics, Mathematics, or related field.
  • Strong proficiency in SAS programming; experience with R or Python a plus.
  • In-depth knowledge of CDISC standards (SDTM and ADaM), FDA/EMA regulatory requirements, and ICH guidelines.
  • Experience with eCTD submission programming and contributing to BLA/NDA/MAA filings preferred.
  • Strong attention to detail and commitment to producing high-quality, audit-ready deliverables.
  • Excellent organizational and communication skills with a proactive, solution-oriented mindset.
  • Ability to work effectively in a lean, cross-functional, start-up environment.

Skills

Statistical Programming
CDISC compliance
SDTM
ADaM
SAS
Clinical Development
Regulatory Submissions
Biostatistics
Data Management
Vendor Oversight

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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