[Remote] Associate Director, Clinical Programming at Abata Therapeutics

Remote

Apply Now

Not SpecifiedCompensation

N/AExperience Level

N/AJob Type

Not SpecifiedVisa

N/AIndustries

Requirements

Bachelor’s Degree in a relevant field
Experience with programming languages like SAS, R, and Python
Knowledge of CDISC standards
Understanding of GCP and regulatory guidelines
Experience with clinical trial data cleaning, validation, and transformation
Experience developing statistical programs and creating tables and figures (TLFs)
Experience with data review systems
Experience with vendor management
Experience with statistical analysis support
Experience with documentation for audit trails and regulatory submissions
Experience building and mentoring a team

Responsibilities

Clean, validate, and transform raw clinical trial data into standardized formats (e.g., CDISC SDTM)
Participate in the review of clinical data and develop processes and guidelines
Develop and execute SAS programs (or other languages) to create datasets, tables, listings, and figures (TLFs)
Build and maintain effective DM vendor relationships
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 efficacy and safety evaluation
Perform quality control (QC) checks on vendor programming work
Collaborate with Biostatistics and Statistical Programming to develop data review standards and tools
Collaborate with various functions to deliver high-quality data in a timely fashion
Ensure all programming and data activities comply with GCP and regulatory guidelines
Maintain comprehensive documentation of programming work
Ensure clinical trials have complete and accurate supporting documentation for regulatory submission
Build and mentor a team of programmers

Skills

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.

Land your dream remote job 3x faster with AI

Try Jobo Free