Principal Biostatistician - Nueroscience FSP (Remote)

Company: Cytel Inc
Location: South Bend
Posted on: June 9, 2021

Job Description:

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 FSP group is growing and hiring well-rounded Principal Biostatisticians to provide statistical support, with a focus on ad-hoc work for clinical studies, and some publications support, across a variety of therapeutic areas.

You will participate in the development of study protocols including participation in study design discussions and sample size calculations, and review CRFs and data review guidelines.

Additionally, you will:

• Develop statistical analysis plans (SAPs) including analysis dataset and TLG specifications
• Perform statistical analyses
• Interpret statistical results
• Help prepare clinical study reports including integrated summaries for submissions

What we need from you:

• MS or PhD in a science or industry-related discipline with five or more (8+) years working on clinical trials.
• Experience in sample size calculation, protocol concept development, protocol development, SAP and preparing clinical study reports including integrated summaries for submissions.
• Good SAS programming skills for QCing critical outputs, Efficacy/Safety tables and working closely with Programmers. 
• Knowledge of R programming a plus.
• Adept in ADaM specifications, generation and QC of datasets.
• Submissions experience strongly desired.
• Experience working with cross-functional teams, a Study Management Team (SMT) or similar teams for different clients.
• Effective communicator: able to explain methodology and consequences of decisions in lay terms.
• Team player; willingness to go the extra distance to get results, meet deadlines, etc.
• Ability to be flexible when priorities change and deal with ambiguity.
• Simulation and protocol design experience strongly 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.

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Keywords: Cytel Inc, South Bend , Principal Biostatistician - Nueroscience FSP (Remote), Other , South Bend, Indiana