Director of After School Programs at Camp Fire Alaska empowering youth through community programs and partnerships. Leading teams and ensuring quality across after - school initiatives in Anchorage, Alaska.
About the role
- Director of Biostatistics managing design and analysis of clinical trials for a biotech company. Leading a Biometrics team with high quality and regulatory compliance in mind.
Responsibilities
- Oversee the design, analysis, and reporting of clinical trial data, ensuring high quality and regulatory compliance.
- Serve as the point of escalation to ensure the timeliness and accuracy of Biometric deliverables.
- Drive development and adherence to Biometric vision, strategy, and operational excellence for global development programs.
- Anticipate new challenges, risks, and needs for the department, and proactively mitigate to ensure business continuity.
- Oversee performance of external vendors responsible for clinical data deliverables to ensure quality completion of all clinical data related deliverables.
- Ensure expert statistical input/review/Q.C. to ensure proper statistical methods are applied, data quality meets or exceed industry and company standards, and data interpretation is accurate internally and externally.
- Lead development of new / streamlining procedures and process improvement to meet the needs of an evolving Biometrics Department.
- Collaborate with partner functions to provide statistical programming, systems analysis, and database management support for important Clinical Development deliverables.
- Participate in the development of the clinical components of regulatory submissions and transfer of clinical data as needed, ensure data deliverables meet regulatory submission requirements.
- Ensure compliance with Clinical Data Interchange Standards Consortium (CDISC) standards to ensure high data quality standards.
Requirements
- Master's degree or higher in Statistics/Biostatistics area
- 8+ years of experience in pharma/biotech industry, with in-depth knowledge of Data Management and Biostatistics processes
- 3+ years of experience in managing a team, including responsibility for projects as well as hiring, managing, mentoring, and/or developing direct reports.
- Strong expertise in clinical data management for Phases I-IV clinical trials and complex study designs in pharma/biotech industry
- Strong working knowledge of Biostatistics processes
- Experience in managing an outsourced data management model.
- Extensive experience with Medidata RAVE and other industry EDC platforms
- Extensive knowledge with GCP, ICH, and FDA and other health authority regulatory requirements as applicable for clinical data management
- Familiarity with CDASH and SDTM standards
Benefits
- Health insurance with FULL premium coverage
- 401K with company match
- Employee Stock Purchase Program (ESPP)
- Competitive paid time off (PTO)
- Company-paid short & long-term disability insurance and life insurance
Job title
Job type
Experience level
Salary
Degree requirement
Tech skills
Location requirements
Adjoint Director managing medical and social establishments in France. Leading strategic projects and coordinating resources with a focus on patient care and quality improvement.
Publishing Director responsible for driving commercial growth and audience engagement in B2B media. Leading strategic decisions across a portfolio of brands in a hybrid work environment.
Director leading the Influencer & Celebrity Relations team at BPCM, a women - led PR agency. Collaborating with teams across LA, NY, and London to drive celebrity partnerships.
Leadership role for developing strategies and expanding partnerships in an international exhibition context. Overseeing a team and contributing to the growth of Fruit Logistica, a major global trade fair.
Senior Director, Strategy responsible for driving client acquisition and business development for pharmaceutical and biotech partners. Collaborating with Insights teams and leading sales strategies.
Director of Maintenance overseeing all maintenance operations at a healthcare facility. Responsible for safety, compliance, team management, and budget oversight.
Assistant Director overseeing Residential Education at WashU, focusing on leadership of Residential Community Directors. Ensuring vibrant community life and supporting resident engagement and development.
Directeur de Produits piloting product line strategies and managing technology requirements for avionic systems. Ensuring alignment with market needs and improving product roadmaps.
Associate Director/Senior Manager leading the execution of Manulife’s Asia strategy and overseeing project management initiatives across markets and functions.