Senior Director, Biometrics at Abata Therapeutics

San Diego, California, United States

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Not SpecifiedCompensation

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

Full TimeJob Type

UnknownVisa

BiotechnologyIndustries

Requirements

Ph.D. or Master’s degree in Biostatistics, Statistics, or a related field
Minimum of 10 years of experience in biostatistics within biotech or pharmaceutical environments
5+ years in a senior leadership role
Demonstrated success in leading biometrics teams through all phases of drug development, including regulatory submissions and health authority interactions
Strong Phase III statistical planning background
Proven track record of strategic planning, innovation, and cross-functional collaboration

Responsibilities

Establish and lead a premier Biometrics department, attracting, developing, and retaining top talent in Data Management, Biostatistics, and Statistical Programming
Actively engage in the design and analysis of clinical trials and preclinical studies
Lead cross-functional initiatives to advance clinical development and regulatory success
Develop and implement statistical analysis plans, including hands-on statistical programming and data analysis as needed
Collaborate closely with Clinical Development and Operations, Regulatory Affairs, Biomarkers, and Data Management teams to ensure robust study designs and accurate data interpretation
Foster synergies between functional areas to support the efficient development of high-quality study deliverables
Provide statistical input and support for regulatory submissions and interactions with health authorities
Ensure the statistical integrity of protocols, statistical analysis plans, clinical study reports, presentations, and publications of clinical trial data
Work with internal and external stakeholders in the design, collection, analysis, reporting, interpretation, and publication of clinical trial data
Set the strategic direction for the Biometrics department, aligning goals with organizational objectives and long-term growth; develop budgets, set priorities, ensure consistency and adherence to standards, and create departmental SOPs
Drive the development and implementation of new innovations, standards, processes, and programming efficiencies across biometrics
Maintain a broad understanding of relevant external trends, anticipate emerging issues, identify strategic needs in technical knowledge, and set the strategic direction to meet regulatory, scientific, and business needs
Oversee CRO biometrics deliverables, including database and CRF development, statistical analysis plans, and interim and final TLF deliverables, ensuring quality and alignment with organizational goals and objectives
Represent the organization at professional societies, external scientific forums, and industry-wide technical discussions
Ensure the statistical integrity of all deliverables and compliance with regulatory requirements; lead quality assurance initiatives and corrective action planning
Provide expertise and consultation as a subject matter expert to project teams and serve as a key point of contact with senior management to continuously assess and improve operational project delivery
Monitor the qualitative and quantitative progress of biometrics implementation activities; oversee study reporting and track key indicators for performance and progress evaluation
Ensure consistent use of study tools, training materials, and compliance with standard processes, policies, and procedures
Other duties as assigned or deemed necessary by management

Skills

Key technologies and capabilities for this role

BiostatisticsStatistical ProgrammingData ManagementClinical Trial DesignStatistical Analysis PlansRegulatory SubmissionsData IntegritySOP Development

Questions & Answers

Common questions about this position

What are the main responsibilities of the Senior Director, Biometrics role?

The role involves providing strategic leadership for the Biometrics function, overseeing clinical and preclinical studies, establishing and leading the department in Data Management, Biostatistics, and Statistical Programming, and collaborating with cross-functional teams for regulatory success.

What skills and experience are required for this position?

Key skills include expertise in biostatistics, statistical programming, data management, clinical trial design and analysis, regulatory compliance, and leadership in building and strategizing biometrics teams.

Is this a remote position or does it require office work?

This information is not specified in the job description.

What is the salary or compensation for this role?

This information is not specified in the job description.

What kind of leadership and collaboration is expected in this role?

The role requires establishing and leading a Biometrics department, attracting top talent, collaborating closely with Clinical Development, Operations, Regulatory Affairs, and other teams, and representing the company externally.

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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