What are the responsibilities and job description for the Principal Quantitative Clinical Pharmacologist - FSP position at Cytel - USA & APAC?
JOB DESCRIPTION
Who Are You?
An experienced Pharmacometrician with a passion for clinical development and analysis, adept at utilizing advanced statistical methods, you will lead quantitative pharmacology activities for clinical studies. 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 Pharmacometrician 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 Pharmacometricians provide advanced analytical and development support and influence for the associated client's trials providing expertise into processes, regulatory strategy, modeling, 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, produce PK/PD modeling, and align study team on strategy.
RESPONSIBILITIES
As a Principal Pharmacometrician, your responsibilities will include:
QUALIFICATIONS
Required
Who Are You?
An experienced Pharmacometrician with a passion for clinical development and analysis, adept at utilizing advanced statistical methods, you will lead quantitative pharmacology activities for clinical studies. 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 Pharmacometrician 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 Pharmacometricians provide advanced analytical and development support and influence for the associated client's trials providing expertise into processes, regulatory strategy, modeling, 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, produce PK/PD modeling, and align study team on strategy.
RESPONSIBILITIES
As a Principal Pharmacometrician, your responsibilities will include:
- Contribute to Pop-PK and PK/PD modeling, and non-compartmental analyses
- Contribute to study design, including Bayesian/adaptive design methodologies
- Create specifications and perform analyses such as time-to-event and longitudinal analysis.
- Review and contribute to study reports and quantitative clinical pharmacology l sections of regulatory submission dossiers, lead electronic submissions of clinical data to regulatory authorities, and participate to meetings with regulatory authorities.
- Develop strong collaboration and communication with sponsor cross-functional teams and sponsor Biostatistics management.
QUALIFICATIONS
Required
- Experience in Pop-PK and PK/PD modelling, and non-compartmental analyses
- Understanding of the broader biopharmaceutical R&D process.
- Excellent organization and multi-tasking capabilities, strong problem-solving and analytical skills.
- Experienced in Phoenix WinNonLin and NLME, and R.