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.
ShortDescriptionStr
Our commitment to developing our staff is only surpassed by our commitment to advancing treatment options available to patients. At Cytel, we work hard to create successful careers with significant professional growth for our employees and as a result work hard to make Cytel successful. Cytel is a place where talent, experience, and integrity come together to advance the state of clinical development.
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:
- Master's degree in Statistics, Biostatistics, or a related discipline. PhD strongly preferred.
- 8-10 years of biostatistics experience supporting clinical trials within the pharmaceutical or biotechnology industry. CRO experience strongly preferred.
- 3-5 years of Study Lead experience working with cross-functional development teams.
- Extensive experience in study design, sample size determination, protocol development, SAP development, efficacy analyses, and preparation of clinical study reports, including integrated summaries for regulatory submissions (ISS/ISE).
- Strong knowledge and practical application of advanced statistical methods, including mixed models, longitudinal analyses, and simulation methodologies.
- Demonstrated experience performing exploratory statistical analyses to support clinical development and decision-making.
- Strong proficiency in R for statistical analyses, simulations, data visualization, and advanced modeling.
- Solid SAS programming skills, including QC of critical outputs, efficacy and safety tables, and close collaboration with Statistical Programmers.
- Strong knowledge of ICH guidelines and regulatory expectations.
- Solid understanding and implementation of CDISC standards for regulatory submissions.
- Experience generating ADaM specifications and performing programmatic review of analysis datasets.
- Regulatory submission experience (ISS/ISE) strongly desired.
- Excellent communication skills with the ability to explain statistical methodology and its implications to both technical and non-technical audiences.
- Strong collaborative mindset with a commitment to delivering high-quality work under tight timelines.
- Ability to thrive in a dynamic environment, manage ambiguity, and adapt to changing priorities.
InternalQualificationsStr
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:
- Master's degree in Statistics, Biostatistics, or a related discipline. PhD strongly preferred.
- 8-10 years of biostatistics experience supporting clinical trials within the pharmaceutical or biotechnology industry. CRO experience strongly preferred.
- 3-5 years of Study Lead experience working with cross-functional development teams.
- Extensive experience in study design, sample size determination, protocol development, SAP development, efficacy analyses, and preparation of clinical study reports, including integrated summaries for regulatory submissions (ISS/ISE).
- Strong knowledge and practical application of advanced statistical methods, including mixed models, longitudinal analyses, and simulation methodologies.
- Demonstrated experience performing exploratory statistical analyses to support clinical development and decision-making.
- Strong proficiency in R for statistical analyses, simulations, data visualization, and advanced modeling.
- Solid SAS programming skills, including QC of critical outputs, efficacy and safety tables, and close collaboration with Statistical Programmers.
- Strong knowledge of ICH guidelines and regulatory expectations.
- Solid understanding and implementation of CDISC standards for regulatory submissions.
- Experience generating ADaM specifications and performing programmatic review of analysis datasets.
- Regulatory submission experience (ISS/ISE) strongly desired.
- Excellent communication skills with the ability to explain statistical methodology and its implications to both technical and non-technical audiences.
- Strong collaborative mindset with a commitment to delivering high-quality work under tight timelines.
- Ability to thrive in a dynamic environment, manage ambiguity, and adapt to changing priorities.
InternalResponsibilitiesStr
ExternalResponsibilitiesStr
