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

Requirements

Candidates must possess a Bachelor's or Master's degree in Computer Science, Statistics, Mathematics, or a related field. Strong proficiency in SAS programming is required, with experience in R or Python being a plus. In-depth knowledge of CDISC standards (SDTM and ADaM), FDA/EMA regulatory requirements, and ICH guidelines is essential. Experience with eCTD submission programming and contributing to BLA/NDA/MAA filings is preferred. Strong attention to detail, excellent organizational and communication skills, and a proactive, solution-oriented mindset are necessary. The ability to work effectively in a lean, cross-functional, start-up environment is also required.

Responsibilities

The Associate Director, Statistical Programming will lead statistical programming activities across clinical development programs, reporting to the Head of Biostatistics. Key responsibilities include building internal capabilities, ensuring high-quality programming deliverables for regulatory and clinical milestones, and working with internal stakeholders. This role involves overseeing vendors, performing CDISC compliance checks, programming ad hoc datasets and tables, listings, and figures (TFL), and ensuring regulatory acceptance of datasets. The individual will lead the development, validation, and documentation of statistical programming deliverables, collaborate with internal teams and CRO partners to ensure quality and compliance, and serve as the primary programming lead across multiple studies or programs. Responsibilities also include developing and maintaining programming standards, tools, and processes, providing strategic input to study design and data flow, reviewing protocols and SAPs, supporting regulatory document preparation, and partnering with various functional teams to ensure alignment of timelines and deliverables. Additionally, the role involves contributing to vendor selection and performance management for programming activities.

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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