NEW! Principal Medical Affairs Biostatistician

Cytel; Cheyenne (WY); Sur place; USD 120 000 - 170 000; Plein temps

Résumé du poste

Cytel Inc. is seeking an experienced Principal Biostatistician to lead statistical activities across multiple clinical studies in a sponsor-dedicated role.

You will design and analyze post-approval and observational studies, write statistical sections of protocols, and collaborate with cross-functional teams to advance drug development. The role emphasizes SAS and R programming, CDISC standards, and strong communication skills.

Qualifications

• PhD in Biostatistics, Statistics, or equivalent required; or MS with 8+ years pharma biostatistics experience.
• Excellent written and oral communication and presentation skills.
• Extensive experience programming in SAS.
• Extensive experience working with clinical studies databases.
• Experience working on post-approval observational and clinical studies.
• Understanding of ICH GCP and general industry practices.
• Experience with R programming language.
• Experience with CDISC standards (SDTM, ADaM, CDASH).

Responsabilités

• Collaborates with Medical Affairs, Medical Communications, and Epidemiology to design post-approval studies.
• Writes the statistical sections of study protocols in consultation with experts.
• Contributes to or prepares statistical analysis plans.
• Collaborates with Data Management on eCRF design.
• Provides statistical guidance on ongoing studies.
• Supports Statistical Programming to implement analyses for all trial data.
• Contributes to observational study reports and regulatory documents.
• Contributes to scientific articles and abstracts.

Connaissances

Communication skills

SAS programming

R programming

Clinical data analysis

Team collaboration

Formation

PhD in Biostatistics

MS in Biostatistics

Outils

SAS

CDISC SDTM/ADaM/CDASH

R

Description du poste

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:

As Medical Affairs Biostatistician, you are responsible for statistical activities in support of Medical Affairs, including contributing to post approval study designs, study protocol and analysis plan development, reviewing and interpreting the analysis of study data, and conducting ad hoc and exploratory analyses. You will have the opportunity to play an integral role helping our clients and the industry shape the future of drug development. Work in an environment designed for an entrepreneurial minded person with a lot of energy, ideas and courage for their implementation.

• Collaborates with Medical Affairs (Medical Research and Value, Evidence & Strategy), Medical Communications and Publications, Epidemiology and Regulatory to design post approval studies.


• Writes the statistical sections of study protocols, while consulting with internal and external experts.


• Contributes to or prepares statistical analysis plans.


• Collaborates with Data Management and Medical Research on design of eCRFs.


• Provides statistical guidance on conduct of ongoing studies.


• Accountable for the collaboration with Statistical Programming to implement statistical analysis of all clinical trial, registry, observational and non-interventional data supporting Medical Affairs needs.


• Contributes observational study reports and regulatory documents, e.g., DSURs, briefing documents, etc.


• Contributes to scientific articles, summarizing data collected in studies.


• Participates in other activities and meetings to support Biostatistics and the Medical Affairs team as needed.


• Reviews abstracts, manuscripts for publications and presentations.

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:

• PhD in Biostatistics, Statistics, or equivalent with at least 5 years pharmaceutical biostatistics experience; or MS with at least 8 years' relevant experience.


• Excellent written and oral communication and presentation skills.


• Extensive experience programming in SAS.


• Extensive experiences working on data analysis with clinical studies database.


• Experience working on post-approval observational and clinical studies.


• Understanding of ICH GCP as well as general knowledge of industry practices and standards.


• Experiences in R programming language and other statistical software.


• Experience with CDISC, including SDTM, ADaM, CDASH.

Cytel Inc. is an Equal Employment / Affi...