Abata Therapeutics

Director of Biostatistics

Waltham, Massachusetts, United States

Not SpecifiedCompensation
Expert & Leadership (9+ years)Experience Level
Full TimeJob Type
UnknownVisa
Biotechnology, Pharmaceuticals, Clinical ResearchIndustries

Requirements

Candidates must possess a Ph.D. in Biostatistics, Statistics, or a related field with at least 7 years of clinical trials experience, or a Master's degree with 10 years of experience. Required qualifications include up-to-date expertise in statistical methodologies for clinical trial design and analysis, the ability to provide statistical leadership to cross-functional teams, knowledge of FDA regulations and ICH guidelines, expertise in CDISC standards (including ADaM requirements), and advanced proficiency in SAS programming. Knowledge of R or similar languages is a plus.

Responsibilities

The Director of Biostatistics will lead the statistical strategy for clinical development programs, including study design, protocol input, and statistical analysis planning. Responsibilities include planning and tracking biostatistics timelines and resources, providing statistical input for data management and programming deliverables, and developing statistical programs for ad-hoc requests, manuscripts, and presentations. The role also involves providing statistical review of scientific reports and publications, writing statistical sections for regulatory documents, collaborating with Clinical and Regulatory teams, and participating in the assessment and oversight of CROs, while ensuring compliance with SOPs and industry standards.

Skills

Biostatistics
Clinical Development
Statistical Methodology
Study Design
Statistical Analysis Plans
Clinical Trial Analysis
Regulatory Submissions
Statistical Leadership
Data Interpretation

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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