- Independently lead the development and execution of statistical aspects for studies of moderate complexity.
- Participate in PRC (Protocol Review Committee) reviews of study protocols and SAPs.
- Provide data interpretation for study documents such as CSR.
- Participate in statistical organization continuous improvement initiatives.
- Be a member of cross-functional development teams and contribute 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, clinical trial manager, medical monitor, clinical scientist, data manager, PK scientist, and other members of the study/indication team.
- Make strategic and scientific contributions at the indication/protocol/integrated analysis level.
- Drive the selection of optimal study designs, data collection, analytic approaches, and rigorous interpretation of trial data.
- Interact with external vendors, key opinion leaders, and regulatory agencies as necessary.
Qualifications and Experience:
- Master s degree in Statistics or equivalent with 5 years of industry-related experience OR Ph.D. in Statistics or equivalent with 3 years of industry-related experience.
- Demonstrated 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 Excretion).
- 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.
- Flexibility and ability to 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.
Preferred Experience:
- Therapeutic Area (TA) experience: Oncology, Cardiology, Immunology, Hematology, Neurology.
- Phase experience: Heavy Phase 1, some Phase 2.
- Ability to overlap working hours from 8am-11am EST
