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Biostatistician

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Date: Jan 13, 2021

Location: Cambridge, MA, US, 02114

Company: Cytel Inc

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.

 

The Biostatistician role will be responsible for the statistical activities for multiple clinical studies, participating in protocol development and executions, ensuring compliance with SOPs to produce quality and timely statistical deliverables.

 

About the Role:

  • Serve as a study biostatistician for multiple clinical studies
  • Contribute to clinical protocol development, including authoring of the section on statistical methods and reviewing/editing of other sections by applying statistical principles
  • Author statistical analysis plans for studies and/or ISS/ISEs, and author/edit shells for tables, figures and listings
  • Review CRF designs to ensure data collection meet the study objectives and the requirements of statistical analyses
  • Provide statistical input to data monitoring committee (DMC) charters, project management plans, and other study-level documents
  • Work with statistical programmers or CROs to generate tables, figures and listings
  • Support ongoing safety review and DMC review of the clinical development program/study teams
  • Perform ad hoc and exploratory statistical analyses as needed
  • Contribute to clinical study reports, including authoring of statistical sections, interpretation of the study results, and QC of the results in the reports.
  • Support regulatory submissions as needed
  • Support the preparation of publications, including manuscripts, posters and oral presentations
  • Provide oversight of CROs for outsourced statistical activities and QC key results generated by CROs

 

About You:

  • MS in biostatistics or similar field
  • 3 years of relevant experience with statistical analysis suporting clinical trials
  • Knowledge of statistical methods for clinical trials
  • Proficient in statistical programming (SAS is required, and R is a plus)
  • Good communication skills and ability to work with cross-functional study teams
  • Ability to multi-task in an extremely fast-paced environment with changing priorities
  • Ability to solve analytical/technical problems
  • Positive, outgoing and collaborative attitude

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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