Principal Biostatistician
5 days ago
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
- 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 (Solid Tumor), late Phase (2 or 3).**
**Sample size calculation and adaptive design is preferred, but not required.**
**The role will be for close-out studies: Abbreviated CSRs, and database lock activities.**
**Weekly meetings at the beginning of the role, aiming for 1-2 hours of overlap with East Coast team. Once established, meetings/overlap would lessen.**
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.
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