Principal Statistician
1 week ago
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 clinical trial manager, medical monitor, clinical scientist, data manager, 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 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 experienceDemonstrated knowledge of statistical/clinical trials methodology as it relates to clinical development.Strong experience with sample size calculation and protocol design.Experience with any of the following: food effect, drug-drug interaction, dose proportionality, special populations (renal impairment, hepatic impairment, elderly population) with some BA/BE (bioavailability/bioequivalence) and ADME (Absorption, Distribution, Metabolism, and ExcretionRelevant prior data analysis planning, execution, and delivery experience.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.
TA experience preferred: Oncology, Cardiology, Immunology, Hematology, Neurology.Phase experience preferred: Heavy Phase 1, some Phase 2.Overlap of 8am-11am EST.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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