2153 - Senior Biostatistician

Company: Cytel Inc
Location: Frederick
Posted on: July 17, 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.

We are experiencing exponential growth on a global scale in our Project-Based Services (PBS) team. You will support Phase I –IV clinical studies across a variety of therapeutic areas.  If you thrive working in a challenging, multi-tasking, deadline-driven environment, you will fit in well with our team of High Achievers!

The Senior Biostatistician provides statistical input into Phase I - IV clinical trial development, performs the analysis of clinical trial data, and provides statistical input into the reporting of clinical trial results. Responsibilities include: providing statistical input into protocol and case report form (CRF) development in all therapeutic areas (e.g., trial design, sample size estimation, randomization, statistical methods for protocols, edit checks for clinical trial data); communicating with clients regarding study protocol or statistical analysis issues; and writing detailed statistical analysis plans including specifications for analysis files, consistency checks, tables, and figures.

The Senior Biostatistician analyzes clinical trial data producing accurate results representing the outcome of the trial, validates statistical output, accurately interprets and clearly communicates statistical results and concepts to non-statisticians. With the medical writer, co-authors final integrated reports of clinical trial data by writing thorough and clear statistical methods sections and producing the statistical appendix for the final report. The Senior Biostatistician also provides statistical output as required for manuscripts and ensures that the results are accurately interpreted in the publications.

The Senior Biostatistician provides input into statistical standard operating procedures (SOPs) and general standardization efforts (e.g., statistical methodology standards, standard data presentations) and participates in interactions with regulatory agencies, as required. In addition, the Senior Biostatistician collaborates effectively with members of clinical trial implementation teams and with Biometrics colleagues, and keeps abreast of new developments in statistics, drug development, and regulatory guidance through literature review and attendance at workshops and professional meetings.

Qualifications and Experience:

• Master's degree in Statistics or Biostatistics
• 5-8 years statistical analysis related to clinical trials or health research environment
• Excellent written and oral communication skills, including grammatical/technical writing skills
• Familiarity with moderately complex statistical methods that apply to Phase I-IV clinical trials are required.
• SAS proficiency including BASE and STAT

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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