Principal Biostatistician - Early Phase Clinical Pharmacology - FSP - Permanent - Remote 1

Date: Feb 8, 2024

Location: IN

Company: Cytel Software Corporation

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

As a Technical Lead, Biostatistics independently leads the development and execution of statistical aspects for studies of low to moderate complexity, participates in PRC (Protocol Review Committee) reviews of study protocols and SAPs, Provides data interpretation for study documents like CSR, Participants in statistical organization continuous improvement initiatives.

 

Summary of Job Responsibilities:

 

  • Member of cross-functional development teams and contributes to trial design, protocol development, analysis planning, interpretation of results, and preparation of regulatory submissions.
  • Have responsibilities for integrated summaries and/or supporting a particular indication of an asset. 
  • Develop collaborative relationships and work effectively with the GBS (Global Biometric Sciences) Biostatistics Lead, the GBS Planning and Execution Lead, the medical monitor, the protocol manager, the data manager, the PK scientist, and other members of the study/indication team.
  • Responsible for strategic and scientific contributions at the indication/protocol/integrated analysis level.
  • Has responsibility for driving the selection of optimal study designs, data collection, analytic approaches, and rigorous interpretation of trial data. This person may interact with external vendors, key opinion leaders, and regulatory agencies.

 

Qualifications and Experience:

 

  • Master's degree in Statistics or equivalent & ≥ 5 years of industry-related experience OR Ph.D. in Statistics or equivalent & ≥ 3 years of industry-related experience
  • Demonstrated knowledge of statistical/clinical trials methodology as it relates to clinical development
  • Relevant prior data analysis planning, execution, and delivery experience
  • Early phase experience required with experience including drug-drug interaction, food effect, dose proportionality, special populations, BA/BE preferred
  • Experience with sample size calculations for a variety of study designs required
  • Ability to work successfully within cross-functional teams leading to successful global regulatory filings and approvals
  • Excellent verbal and written communication skills.
  • Ability to be flexible and adapt quickly to the changing needs of the organization.
  • Ability to organize multiple work assignments and establish priorities.
  • Strong interpersonal skills evidenced in interactions with individuals at all levels of the organization and demonstrated ability to develop relationships within the organization and leverage the formal and informal organizational structure to assist in goal achievement.

 

 

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.