Principal Biostatistician - Oncology

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 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.

As Principal Biostatistician, you will leverage your knowledge and experience in applying advanced statistical methods and SAS skills to lead or help drive one or more Phase I-IV trials, with a focus on Oncology and Infectious Disease studies.

You will contribute by:

• participating in the development of study protocols, including participation in study design discussions and sample size calculations;
• reviewing CRFs and data review guidelines; developing statistical analysis plans (SAPs), including analysis dataset and TLG specifications;
• performing statistical analyses;
• interpreting statistical results;
• preparing clinical study reports, including integrated summaries for submissions (ISS/ISE);
• leading study activities when called upon;
• utilizing your strong communication skills to present and explain methodology and consequences of decisions in lay terms;
• serving as a team player, with a willingness to go the extra distance to get results, meet deadlines, etc.;
• being adaptable and flexible when priorities change

What we are looking for:

• Master’s degree in statistics or a related discipline. PhD strongly desired.

• 8-10 years supporting clinical trials in the Pharmaceutical or Biotechnology industry. Experience working for a CRO strongly desired.
• Experience in Medical Affairs, Oncology, Immunology or Cardiovascular strongly desired.
• 3-5 years of Study Lead experience working with cross-functional teams.
• Experience in sample size calculation, protocol concept development, protocol development, SAP and preparing clinical study reports including integrated summaries for submissions.
• Knowledge and implementation of advanced statistical methods.
• Good SAS programming skills for QCing critical outputs, Efficacy/Safety tables and working closely with Programmers. Knowledge of R programming a plus.
• Strong knowledge of ICH guidelines.
• Solid understanding & implementation of CDISC requirement for regulatory submissions.
• Adept in ADaM specifications generation and programmatic review of datasets.
• Submissions experience (ISS/ISE) strongly desired.
• 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

What’s in it for you:

• You will have the opportunity to play an integral role helping our clients and the industry shape the future of drug development
• You will be part of an exciting new chapter in Cytel’s history with high growth and opportunities to progress in Senior and Leadership positions within the company
• Work in an environment designed for an entrepreneurial minded person with a lot of energy, ideas and courage for their implementation
• Work with and leverage the best and brightest minds in the industry

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.

Keywords: Cytel Inc, South Bend , Principal Biostatistician - Oncology, Other , South Bend, Indiana