NEW! Principal Medical Affairs Biostatistician

Cytel; Topeka (KS); Sur place; USD 140 000 - 200 000; Plein temps

Résumé du poste

Cytel is seeking an experienced Principal Biostatistician/Medical Affairs Biostatistician to lead statistical activities for Phase I–IV clinical studies within a client-embedded model. You will drive study designs, SAPs, and analyses while collaborating with Medical Affairs, Regulatory, and Publications teams.

The role requires strong communication, SAS/R expertise, and CDISC proficiency. You will mentor teams and contribute to scientific manuscripts and regulatory documents.

Qualifications

• PhD in Biostatistics or equivalent is required or an MS with substantial pharma biostatistics experience.
• Strong ability to design and interpret analyses for Medical Affairs and regulatory needs.
• Experience writing statistical sections of protocols and SAPs; ability to guide cross-functional teams.

Responsabilités

• Collaborates with Medical Affairs, Medical Communications, Publications, Epidemiology, and Regulatory to design post-approval studies.
• Writes statistical sections of study protocols and consults with experts.
• Prepares statistical analysis plans and designs eCRFs with Data Management.
• Provides statistical guidance for ongoing studies and collaborates on data interpretation.
• Contributes to observational studies, DSURs and regulatory documents.
• Contributes to scientific articles and conference abstracts.
• Participates in meetings to support Biostatistics and Medical Affairs.
• Reviews abstracts and manuscripts for publications.

Connaissances

Leadership

Communication

Clinical development

Collaborative work

Statistical methodology

Formation

PhD in Biostatistics or related field

MS in Biostatistics with 8+ years pharma experience

Outils

SAS

R

CDISC (SDTM/ADaM/CDASH)

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...