[Remote] Associate Director, Clinical Programming at Abata Therapeutics

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Not SpecifiedCompensation

Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

BiotechnologyIndustries

Requirements

Bachelor’s Degree in a relevant field (e.g., computer science, statistics, life sciences, or related discipline)
Proficiency in programming languages like SAS, R, and Python
Experience with CDISC standards (e.g., SDTM)
Knowledge of Good Clinical Practice (GCP) and regulatory guidelines
Experience in clinical trial data management and statistical programming

Responsibilities

Clean, validate, and transform raw clinical trial data from various sources into standardized formats, such as CDISC SDTM
Participate in the review of clinical data, including support for data review systems, development of processes and guidelines, and production of custom database reports
Develop and execute SAS programs (or other languages like R/Python) to create datasets, tables, listings, and figures (TLFs) as specified in the Statistical Analysis Plan (SAP)
Build effective DM vendor relationships, including involvement in RFP development, contract negotiation, and selection of DM CROs and/or technology, as needed
Work closely with CROs to prepare and ensure proper development and execution of data management activities
Review protocols to ensure database feasibility
Perform statistical analyses support for the efficacy and safety evaluation of treatments
Perform quality control (QC) checks on vendor programming work, including SAS code and generated outputs, to ensure accuracy and adherence to standards
Collaborate with Biostatistics and Statistical Programming to develop data review standards and tools, including visualization tools if needed
Work collaboratively with Biostatistics, Statistical Programming, Clinical Operations, Regulatory, Pharmacovigilance, and other functions to deliver high quality data in timely fashion, and to design analyses, interpret results, and solve programming challenges
Ensure all programming and data activities comply with Good Clinical Practice (GCP) and regulatory agency guidelines
Maintain comprehensive documentation of programming work for audit trails and regulatory submissions
Ensure that all clinical trials have complete and accurate supporting documentation for regulatory submission including raw datasets and bookmarked, annotated CRFs
Build and mentor a team of programmer(s) to effectively support clinical trials and pipeline

Skills

SAS

Python

CDISC

Statistical Programming

Data Cleaning

Data Validation

Clinical Trial Data

Regulatory Submissions

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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