Vice President, Services
Kivo
Director / Senior Director, Biostatistical Consulting
Allucent
full-time
Posted on:
Origin: • 🇺🇸 United States
Visit company websiteJob Level
Senior
About the role
- Provide statistical consulting to sponsors to support clinical program development, protocol development, sample size calculations, endpoint selection, regulatory interactions, exploratory analyses, scientific meetings, and executive decisions
- Provide statistical consulting for complex and/or novel statistical analyses
- Provide statistical consulting to support clinical development strategies, including extensive interface with client executive and leadership teams
- Provide input and support responses to regulatory questions on statistical issues relating to client regulatory submissions, interacting with and attending meetings with regulatory bodies as applicable
- Prepare statistical analysis plans (SAPs) and table, listing, and figure (TLF) mocks for any complexity of study
- Provide senior reviews of statistical documents, data, and outputs for studies of all complexities to ensure quality and integrity
- Execute a statistical analysis of any complexity as specified in a protocol or analysis plan
- Interpret and communicate results for complex statistical analyses and outputs
- Develop and/or review the statistical sections of a study protocol for studies of any complexity level
- Review statistical sections of a clinical study report to ensure accurate descriptions of statistical methods used and results of analyses
- Provide randomization materials including randomization schedules and treatment kit lists per Allucent SOPs and the sponsor-approved specifications
- Develop or review documents for integrated analyses (e.g. ISS/ISE), including integrated SAPs and statistical sections of integrated study reports
- Working knowledge of SAS® for production and validation of datasets and statistical outputs
- Write and review specifications for complex ADaM or analysis datasets · Annotate or review annotations of TLF mocks to assist programming efforts
- Working knowledge of CDISC standards
- Review CRF design to ensure it conforms with the study protocol and analysis needs
- Review data management documents as requested to ensure integrity of study data
- Lead highly complex projects by fulfilling the following responsibilities: communicate with the client and statistical team, set and achieve timelines and milestones, ensure proper execution of the study SAP, monitor programming efforts in collaboration with the lead programmer, and work with management to ensure adequate resourcing
- Function as the lead unblinded statistician for studies and manage unblinded tasks including implementation of interim analyses and participation in DMC/safety review meetings
- Accountable for leading biostatistics and programming activities for a program of studies of high complexity and/or of high value
- Identify high-risk or high-impact deliverables and assign appropriate oversight
- Lead and manage project budgets, support financial reporting for studies, identify of out-of-scope work and provide leadership in change order process
- Collaborate with and verify open communication with other functional areas and business units
- Provide biometrics leadership and coordination across client and other vendor functional areas, including clinical operations, pharmacovigilance, regulatory, and medical writing teams
- Represent Allucent at proposal bid defenses and/or marketing meetings with prospective clients
- Provide key input into project proposals and budgets
- Establish positive relationships with current and future clients
- Identify key accounts and maintain strong long-lasting relationships to win new and repeat business
- Monitor and assure client satisfaction on existing projects for biostatistics and statistical programming
- Contribute to BIOSC, BBU, and corporate marketing activities via blogs, webinars, white papers, and other publications and presentations
- Contribute to other areas of business and assignments as required
Requirements
- Graduate degree (Master’s degree/local equivalent, or higher) in a relevant discipline including, but not limited to, statistics, mathematics, life science, epidemiology, or healthcare
- Must have strong experience in Bayesian designs specifically in oncology studies.
- Minimum 15 years of relevant work experience
- Minimum 10 years of experience in drug development and/or clinical research
- Thorough knowledge of GxP
- Strong familiarity with relevant regulations and guidelines
- GDPR/HIPPA, CFR/CTR/CTD and applicable (local) regulatory requirements
- Working knowledge of computer systems, applications and operating systems
- Demonstration of critical thinking and analytic skills
- Broad knowledge of drug development
- Ability to simplify complex issues into understandable concepts
- Proficient with one or more sample size software packages
- Strong technical skills with proficiency in SAS and/or other statistical programming languages
- Strong written and verbal communication skills including good command of English language
- Collaborative and client-focused
- Ability to work in a fast-paced challenging environment of a growing company
- Administrative excellence
- Strong leadership skills
- Effective at problem solving, strategic thinking and conflict resolution
- Strong presentation and networking capabilities
- Excellent organizational, negotiating and financial skills
- Knowledge of SAS
- Proficiency with various computer applications such as Word, Excel, and PowerPoint
- Strong individual initiative
- Excellent attention to detail and commitment to quality
- Ability to establish and maintain effective working relationships with co-workers, managers, clients, and vendors
- Ability to effectively manage multiple tasks and projects
- Reputation as a leader with sustained performance and accomplishment
