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Principal Biostatistician

Employer
Cytel - EMEA
Location
FR;Homeworking
Salary
Competitive
Start date
30 Oct 2022
Closing date
29 Nov 2022

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Job Details

Cytel provides unrivaled biostatistics and operations research knowledge to our customers in the life sciences industries in the form of both software and services. At Cytel, we work hard to create successful careers with significant professional growth for our employees, as a result of which they work hard to make Cytel successful. Cytel is a place where talent, experience and integrity come together to advance the state of clinical development.

Cytel's Flexible Solutions Program (FSP) offers statistical programmers, biostatisticians and clinical data specialists amazing opportunities to work on client projects supporting clinical trial design and analysis.

The Principal Biostatistician will provide statistical leadership and influence for client's other 3rd party CRO resources as well asstatistical expertise into clinical development plans, concept sheets and protocols for clinical development projects, represent Cytel and the statistical team on the Product Development Teams of sponsors. Additionally, will haveoversight of statistical analysis plans, statistical outputs, and other documentation.

Responsibilities include but are not limited to:
  • Provide statistical input into study protocols, Case Report Forms, and data management plans, DSMBs and write statistical analysis plans, review or create analysis dataset specifications, and perform statistical analyses.
  • Provide statistical output as required for manuscripts and ensures that the results are accurately interpreted in the publications.
  • Review and contribute to study reports and clinical and statistical sections of regulatory submission dossiers, lead electronic submissions of clinical data to regulatory authorities, and participate to meetings with regulatory authorities.
  • When in the Lead Biostatistician role for a project: manage biostatisticians and statistical programmers with respect to statistical strategy, deliverables and processes.
  • Generate the use of innovative statistical methodology approaches by identifying, adapting, developing or using optimal statistical research methodologies and techniques appropriate to each project, and contribute internally and externally to the development and visibility of the company and of the Clinical Services department through her/his expertise and customer orientation.
  • Contribute to the development of sourcing strategy for projects.
  • Develop strong collaboration and communication with sponsor cross-functional teams and sponsor Biostatistics management.


Qualifications and Experience:

  • PhD in statistics or Master's degree with relevent industry experience
  • >3year’s experience in statistical or biostatistical analysis supporting clinical trial operations for the pharma/biotech industry
  • Experience working on phase I, II and/or IIIclinical trials required
  • Understanding of the application of biostatistics to medical/clinical trials data
  • Excellent verbal and written communications skills
  • Ability to organize multiple work assignments and establish priorities
  • Hematology/Oncology experience preferred
  • Submission experience (BLA/sBLA/NDA/sNDA) a plus
  • Demonstrated team leadership for direct reporting relationships and leadership influence over indirect reporting relationships
  • Knowledge of relevant international regulatory guidelines applicable to clinical development, and some experience of regulatory interactions and data submission to FDA required
  • Working SAS & CDISC knowledge required


#LI-JH1 #CYTELINT

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.

Cytel does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact Cytel’s human resources department to obtain prior written authorization before referring any candidates to Cytel. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and Cytel. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of Cytel. Cytel shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies.

Company

Who We Are

The clinical development of drugs and devices is crucial for human welfare. Our mission is to improve success rates in this endeavor.

We do this by improving the design and implementation of clinical trials through the innovative application of statistical science, operations research, and information technology.

What We Do

We provide unrivaled biostatistics and operations research knowledge to our customers. Our knowledge is available in the form of both software and services. This knowledge, supported by our trial implementation capabilities, is what makes us different. We are leaders in the design and implementation of adaptive clinical trials.

Find Us
Website
Mini-site
Cytel - EMEA
Telephone
+41 22 761 70 20
Location
Clinical Research Services
ICC, Building H, 2nd floor
Route de Pré-Bois, 20 C.P. 1839
Geneva
20 C.P. 1839
CH
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