Principal Biostatistician - GI / Dermatology / Late-Phase Trials / eSUB (Remote, US / Canada) Details

Principal Biostatistician - GI / Dermatology / Late-Phase Trials / eSUB (Remote, US / Canada)

Cytel, Inc (USA) - Madison, WI

Employment Type : Full-Time

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 as statistical 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 have oversight 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:

• Master's degree in Statistics, Biostatistics or related discipline
• 5-10 year’s experience in statistical or biostatistical analysis supporting clinical trial operations for the pharma/biotech industry
• Experience in eSUB and contributing to and reviewing the summary of clinical pharmacology required
• Experience with integrated PK analyses and clinical pharmacology is required
• Experience in immunology, dermatology or gastroenterology 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
• Knowledge of PK/PD desired

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.