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Principal Biostatistician

Date: Oct 11, 2021

Location: SG

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.

 

Summary of Job Responsibilities:

  • Provide statistical expertise into clinical trial designs

  • Serve as functional lead on project teams

  • Develop and review input for clinical trial activities (trial design, protocol, CRF, SS, SAP, specifications, randomization, DB lock activities, analysis, programming and validation, regulatory submission documents)

  • Interact and coordinate with client staff

  • Review and perform oversight of analysis plans, statistical analyses, outputs, and datasets provided by another vendor

  • Coordinate activities of other personnel

  • Review financial reports, budget proposals and attend bid defense meetings

  • Deliver training and/or mentoring to less experienced staff in advanced statistical methodologies. 

  • Provide technical leadership for Biostatistics Group and lead initiatives


Qualifications and Experience:

  • Minimum Education: Ph.D. or MS in Statistics, Biostatistics or related discipline.
  • With PhD, a minimum of six year of industry experience; with MS, a minimum of eight years of industry experience


Skills:

  • Advanced Knowledge of statistical methodology and analytic techniques

  • SAS programming skills, R programming skills a plus

  • Extensive knowledge of FDA and ICH regulations and industry applicable standards.

  • Advanced knowledge of the pharmaceutical industry including understanding of clinical drug development process and associated documents.

  • Excellent oral and written communication skills

 

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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