3590 - Principal Biostatistician

Company: Cytel Inc
Location: Rockville
Posted on: July 16, 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.

You will have the ability to effectively convey statistical concepts to non-statistical personnel, experience in more advanced design methodologies and statistical techniques, good communication and presentation skills, project management and team leadership, and good organizational skills with the ability to multi-task.

Statistical responsibilities include:

• participating in the development of study protocols, including participation in study design discussions and sample size calculations;
• developing statistical analysis plans (SAPs), including analysis data and TLG specifications;
• performing statistical analysis;
• interpreting statistical results;
• preparing final analyses and outputs, including integrated summaries for submissions

Leadership responsibilities include:

• leading study activities, training and supervising Cytel’s staff;
• performing general project management;
• supporting business development for new project work;
• utilizing your strong communication skills to present and explain methodology and consequences of decisions in lay terms;
• mentoring statisticians that may be new to certain types of studies and/or therapeutic areas;
• leading by example, 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 you offer:

• PhD or Master’s degree in a related field
• 8+ years working in clinical trials with at least 3 years working in a CRO environment. 
• 5+ years of leading Biostatisticians or cross-functional teams.
• Clinical trial designs in Phase I – IV studies, with experience in Adaptive or Group Sequential designs a plus.
• Thorough understanding of statistical principles.
• Experienced in SAS programming, and knowledge of SAS procedures and other statistical software (i.e. R, EAST)
• Submissions experience preferred.
• Experience presenting to the DMC, blinded and un-blinded results
• Adept in CDISC ADaM / SDTM standards, with experience in the generation of ADaM specifications and QC of datasets strongly desired.
• Excellent communication and organizational skills.

Why Cytel?

• Our collaborative working environment encourages innovation and rewards results, and we are proud to have one of the lowest turnover rates in the industry.
• In addition to a competitive compensation, we offer an excellent benefit’s package, annual bonus incentive, promote work-life balance, and the opportunity to grow with us!

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, Rockville , 3590 - Principal Biostatistician, Other , Rockville, Maryland