Associate Director, Biostatistics

Remote

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Not SpecifiedCompensation

Senior (5 to 8 years), Expert & Leadership (9+ years)Experience Level

Full TimeJob Type

UnknownVisa

Biotechnology, Pharmaceuticals, Biologics, Clinical ResearchIndustries

Requirements

Candidates should have a PhD in statistics or an MS in statistics, biostatistics, or mathematics with significant relevant experience in drug development statistical research. A minimum of 8 years of progressive clinical trial experience is required, with a preference for experience in phase 3 studies and regulatory submissions. Experience leading teams and working in a matrix organization is also necessary, along with excellent communication skills for presenting complex statistical information to diverse stakeholders.

Responsibilities

The Associate Director of Biostatistics will serve as the statistical lead for clinical studies, providing technical leadership and statistical support for study design, conduct, and execution. Responsibilities include partnering with cross-functional teams, contributing to development plans and regulatory interactions, authoring/reviewing statistical sections of protocols and analysis plans, performing sample size determinations, and ensuring statistical integrity of clinical study results. The role also involves overseeing vendor/CRO biostatistics teams, conducting exploratory analyses, evaluating innovative statistical methods, managing relationships with external partners, and ensuring timely delivery of high-quality reports.

Skills

Biostatistics

Statistical Analysis

Clinical Study Design

Protocol Development

Sample Size Determination

Statistical Analysis Plan (SAP)

ADaM Specifications

Data Monitoring Committee (DMC) Charter

Regulatory Interactions

Biotechnology

Immunology

Antibody Engineering

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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