905 - Principal Biostatistician - Medical Affairs, Oncology, Immunology, CV (Remote, US)

Join us in playing an important part in helping our clients drive healthcare forward and ultimately improve human health outcomes! Cytel provides unrivalled biostatistics and operations research to improve drug development success rates, crucial for human welfare. Focused on using innovative applications of statistical science and adaptive clinical trial design, Cytel is at the cutting edge of technology and human ingenuity, driving healthcare forward. We are hiring remote Principal Biostatisticians for our growing FSP division. This position reports to the Sr. Director, Biostatistics. Your Impact 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 any of the following; Medical Affairs, Oncology, Cardiovascular or Immunology 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. Apply tot his job Apply To this Job