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Associate Director Biostatistician

Employer
Ambrx, Inc.
Location
Remote
Salary
$188,000 - $212,000
Start date
Feb 6, 2024

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Discipline
Science/R&D, Biostatistics
Required Education
Masters Degree/MBA
Position Type
Full time

What We Do:

Ambrx Biopharma, Inc. is a clinical-stage biologics company focused on discovering and developing a novel class of specific and selective engineered precision biologics, using our proprietary platform technology that allows site-specific incorporation of synthetic amino acids (SAAs) into proteins within living cells. Our product candidates are designed to overcome the inherent limitations of conventional conjugation approaches that use non-site-specific conjugation, in order to optimize for safety and efficacy benefits across multiple therapeutic classes in broad therapeutic areas.

How will you contribute to our mission:

This role will be responsible for the design, analysis and interpretation of clinical trials data, ensuring the highest quality standards and regulatory compliance, support and work closely with various other functions in clinical development, such as clinical pharmacology, clinical sciences, clinical operations, data management, medical affairs and regulatory sciences. This position will report to the Vice President and Head of Biostatistics and Data Science.

  • Support the collection, analyses and interpretation of clinical trial data: including working with data management and clinical operations in CRF and database development to ensure quality data are collected; work with clinical colleagues to understand trial data; ensure the right statistical methods are applied; and conduct hands-on analysis to provide or validate the right results and interpretation of data to clinical and development questions. 
  • Contribute to the design and development of clinical trial protocols, including sample size calculations, randomization, and statistical analysis plans (SAPs).
  • Perform and oversee the statistical analysis of clinical trial data, including safety and efficacy endpoints.
  • Review and validate outputs including SDTM/ADAM specs and datasets, TLFs, define files and review guides, ensure data integrity, quality, and accuracy.
  • Prepare and review statistical sections of regulatory submissions (e.g., INDs, NDAs, BLAs), ensuring compliance with regulatory guidelines and standards.
  • Work with CROs to support data processing, standardization, transfer and integration.
  • Utilize statistical software (e.g., SAS, R) to conduct hands-on data analyses
  • Implements automation techniques for timely delivery of safety and efficacy data.
  • Stay up to date with statistical methods and regulatory trends in oncology clinical trials.
  • Contribute to the enhancement of departmental processes and best practices.

What you will need for consideration:

  • Advanced degree in Statistics/Biostatistics or a related field.
  • Substantial experience in biostatistics within the pharmaceutical industry.
  • Solid working knowledge and experience in oncology clinical trials
  • Familiarity with relevant regulatory guidelines and requirements (FDA, EMA, ICH), experience in regulatory submissions preferrable.
  • Excellent communication and interpersonal skills.
  • Extensive SAS and R programming experience and agility; willing to conduct hands-on analysis and get deeply involved in clinical trial data to generate insight and knowledge.
  • Ability to work effectively in a fast-paced and collaborative team environment.
  • Detail-oriented and committed to maintaining data accuracy and quality.

Pay Scale:

The pay scale for this position is: $188,000 - $212,000 commensurate with experience. We believe this to be possible compensation for this role at the time of this posting, and we may modify this pay scale in the future.

As an equal opportunity employer, Ambrx is committed to a diverse workforce. Ambrx will consider all qualified applicants without regard to race, color, religion, national origin, gender, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, or other non-job related characteristics or other prohibited grounds specified in applicable federal, state and local laws.

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