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Clinical Development Biotech Jobs in Arizona (NOW HIRING)

An experienced Principal Biostatistician with a passion for clinical development and analysis ... Biotechnology industry. * Ability to work independently, demonstrate initiative and flexibility ...

An experienced Principal Biostatistician with a passion for clinical development and analysis ... Biotechnology industry. * Ability to work independently, demonstrate initiative and flexibility ...

Collaborate with internal and external cross-functional teams (Clinical Development, Regulatory ... Minimum 10+ years of experience in the pharmaceutical, biotech, or scientific consulting industry ...

... clinical trials at a biotech, pharmaceutical or CRO company, having a strong understanding of clinical development programs in a global setting * Experience at or oversight of outside clinical ...

About MMS MMS is an innovative, data-focused CRO that supports the pharmaceutical, biotech, and ... Write and edit clinical development documents, including but not limited to, clinical protocols ...

We support the pharmaceutical, biotech, and medical device industries with our proven, scientific ... Provide statistical consultancy support to sponsors across the full span of clinical development ...

IQVIA Biotech is a full-service CRO purpose-built to serve biotech sponsors. With over 25 years of ... Ensure adherence to study tools, training materials, and processes Team Leadership & Development

IQVIA Biotech is a full-service CRO purpose-built to serve biotech sponsors. With over 25 years of ... Ensure adherence to study tools, training materials, and processes Team Leadership & Development

IQVIA Biotech is a full-service CRO purpose-built to serve biotech sponsors. With over 25 years of ... Ensure adherence to study tools, training materials, and processes Team Leadership & Development

IQVIA Biotech is a full-service CRO purpose-built to serve biotech sponsors. With over 25 years of ... Ensure adherence to study tools, training materials, and processes Team Leadership & Development

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Clinical Development Biotech information

What is clinical development in biotech?

Clinical development in biotech refers to the process of testing new drugs or therapies in human participants to determine their safety and effectiveness. This phase follows preclinical research and involves multiple stages of clinical trials, from Phase I (safety) to Phase III (efficacy and monitoring of side effects). Clinical development professionals coordinate the design, implementation, and analysis of these studies, ensuring compliance with regulatory standards. Their work is crucial in bringing innovative treatments from the laboratory to patients. Success in this field requires knowledge of medical science, regulatory guidelines, and project management.

What are the key skills and qualifications needed to thrive as a clinical development professional in biotech?

To thrive in Clinical Development within biotech, you need a strong background in life sciences, clinical trials management, and regulatory compliance, often supported by an advanced degree (e.g., PhD, PharmD, or MD). Proficiency with clinical trial management systems (CTMS), data analysis tools, and familiarity with ICH-GCP guidelines and FDA regulations are typically required. Strong project management, communication, and problem-solving skills help navigate complex studies and multidisciplinary teams. These competencies are essential to ensure safe, efficient, and compliant development of new therapies from concept to market.

What are the typical challenges faced by professionals working in clinical development within the biotech industry?

Professionals in clinical development for biotech companies often encounter challenges related to navigating complex regulatory requirements, managing tight timelines, and ensuring robust data quality across clinical trials. Additionally, frequent cross-functional collaboration is needed, as teams work closely with regulatory affairs, medical affairs, and data management to drive studies forward. Adapting to evolving scientific advancements and shifting project priorities are also common, so flexibility and strong communication skills are essential for success in this fast-paced environment.

What is the difference between Clinical Development Biotech vs Clinical Research Associate?

AspectClinical Development BiotechClinical Research Associate
Required CredentialsBachelor's or higher in life sciences, relevant certificationsBachelor's in life sciences, often with CRA certification
Work EnvironmentPharmaceutical/biotech companies, labs, clinical trial teamsMonitoring sites, clinical trial sites, sponsor offices
Employer & Industry UsageBiotech firms, pharmaceutical companies, CROsPharmaceutical companies, CROs, research organizations
Common Search & ComparisonYesYes

The Clinical Development Biotech role focuses on planning and managing clinical trials within biotech companies, often involving protocol development and regulatory submissions. In contrast, a Clinical Research Associate primarily monitors clinical trial sites to ensure compliance and data integrity. While both roles require similar educational backgrounds and certifications, their daily responsibilities and work environments differ, with the former being more involved in trial design and the latter in trial oversight.

What are popular job titles related to Clinical Development Biotech jobs in Arizona?

For Clinical Development Biotech jobs in Arizona, the most frequently searched job titles are:

What cities in Arizona are hiring for Clinical Development Biotech jobs?

Cities in Arizona with the most Clinical Development Biotech job openings:

Principal Biostatistician FSP

Cytel

Phoenix, AZ • On-site

Full-time

Posted 8 days ago


Job description

Who Are You?

An experienced Principal Biostatistician with a passion for clinical development and analysis, adept at utilizing advanced statistical methods, you will lead one Phase I-IV clinical studies across your region. You are excited and enthusiastic, motivate your teams to do great work and collaborate easily with your clients. You never settle for what is, but always push clinical development forward to what it could be. You motivate others to do the same.

Sponsor-dedicated:

Working fully embedded within one of our pharmaceutical clients, with the support of Cytel right behind you, you'll be at the heart of our client's innovation. As a Biostatistician you will be dedicated to one of our global pharmaceutical clients; a company that is driving the next generation of patient treatment, where individuals are empowered to work with autonomy and ownership. This is an exciting time to be a part of this new program.

Position Overview:

Our Principal Biostatisticians provide statistical and development support and influence for the associated client's trials providing expertise into processes, clinical development plans, concept sheets and protocols, as well as potentially providing oversight of work supported by other vendors. You will formulate integrated analytical approach to mine data sources, employ statistical methods, machine learning & deep learning algorithms to discover actionable insights and automate process for reducing effort and time for repeated use.

As a Principal Biostatistician, your responsibilities will include:

  • Lead statistical activities for assigned Clinical Trials (Phases 1 to 4) independently from protocol design to reporting of results.
  • Represent Statistics function on cross-functional trial (and possibly indication / project) teams and collaborate effectively with all cross-functional stakeholders.
  • Oversight of internal programming activities and/or CRO contributions on assigned clinical trials and other activities.
  • Contribute to or lead other activities from a statistical perspective as appropriate, including but not limited to Safety Reporting, ISS/ISE, addressing questions from Health Authorities, Publications.
  • Use SAS and/or R for purposes like QC of datasets and deliverables, inferential statistical analyses, modelling/simulation, exploratory analyses etc.
  • Contribute to and participate in other initiatives at Cytel or sponsor side as appropriate.
  • Oversight of more junior Statisticians as required.
  • Seeking an independent study level lead who
  • has a clear technical understanding of how to analyze clinical trial data properly (ICH E9 guideline)
  • experiences of representing biostats function to collaborate with stakeholders cross functionally
  • is equipped with strong communication skills
  • has a strong self-learning willingness to perform their own duties with minimum guidance.

Here at Cytel we want our employees to succeed and we enable this success through consistent training, development and support. To be successful in this position you will have:

  • Minimum of Bachelor's degree in statistics or a related discipline.
  • 9+ years supporting clinical trials in the Pharmaceutical or Biotechnology industry.
  • Ability to work independently, demonstrate initiative and flexibility through effective and innovative leadership.
  • Attention to detail and quality focused, excellent interpersonal and communication skills, innovative, and collaborative behaviours
  • SAS programming skills for QCing critical outputs, Efficacy/Safety tables, and working closely with Programmers.
  • Knowledge of R programming (R Shiny/Python).

Cytel Inc. is an Equal Employment / Affirmative Action Employer. Applicants are considered for all positions without regard to race, color, religion, sex, national origin, age, veteran status, disability, sexual orientation, gender identity or expression, or any other characteristics protected by law.