Intercept Pharmaceuticals Senior Director, Biostatistics in San Diego, California
The Sr. Director, Biostatistics will have responsibility and accountability of Biostatistics as it relates to all stages of development for one or multiple therapeutic areas including the clinical-related components of regulatory submissions, either Clinical Trial Applications or New Drug Applications, to Post-marketing activities. This position may represent Biostatistics on the clinical and project teams across the company’s portfolio, providing subject matter expertise to the Clinical program. The Sr. Director of Biostatistics is expected to provide oversight and supervision of relevant external consultants and clinical research organizations, primarily as it relates to statistical work; Supervise internal and external Biostatistics personnel to analyze and present data based on agreed-to specifications. He/she will help develop, create, verify/validate and maintain all programs for assigned projects in compliance with standard operating procedures. The Sr. Director of Biostatistics is also expected to provide input for cross functional standardization and harmony, technology and process improvement and resource forecasting. He/she may also represent the Executive Director or Vice President as needed.
To perform this job successfully an individual must be able to perform each essential function satisfactorily.
Provide leadership and represent biostatistics at high-level cross-functional interactions related to scientific goals, filing execution and/or strategy.
Maintain the full-scope of responsibility for assigned projects: ensure on-time delivery, communicate the status of projects to internal teams and vendors, execute quality assurance procedures on work produced by others and ensure statistical analysis is being done according to specifications
Identify and manage appropriate statistical consultants to assist with research programs.
Provide Biostatistics subject matter expertise to the clinical and projects teams as appropriate; Liaise with non-clinical and pre-clinical teams regarding the conduct of experiments, statistical methodology, data analysis and interpretation, and regulatory issues.
Assume responsibility for statistical components of regulatory submissions; Ensure that all activities are conducted in compliance and relevant regulatory requirements
Influence the broader organization with respect to innovation in clinical study design and/or analysis methods.
Provide statistical oversight of other company Biostatisticians as appropriate.
Review clinical study protocols, providing statistical feedback and input on project design issues, endpoint definition and sample sizes; Provide sample size calculation and documentation
Facilitate and maintain communication between Biostatistics and cross-functional areas to include Clinical Research, Clinical Operations, data management, Regulatory Operations, Pharmacovigilance, Medical Monitoring in developing and maintaining consistent processes.
Provide statistical support of the strategic planning, authoring, and review of manuscripts and other scientific data disclosures.
Responsible for statistical activities associated with clinical research studies across all stages of development and with programs leading to regulatory submissions.
Assign and manage resource to meet overall and critical project deliveries; Supervise Biostatistics-related work conducted by relevant external consultants and clinical research organizations
Review Case Report Forms to ensure data is collected appropriately to achieve the analysis defined in the protocol
Write and/or review Statistical Analysis Plans including Mock tables, listings and figures; Review programming specifications
Ensure table, listing, figure and statistical analysis programming is being done according to specifications.
Create and maintain analyses, tables/listings/figures
Provide guidance into development and implementation of data management and statistical programming standards and ensures that the standards are followed.
Define, drive and prepare (or supervise preparation of) statistical strategic and quantitative contributions to regulatory/submission strategy and related documents (e.g.: Briefing Books, NDA/CTD, Regulatory Responses).
Lead the development and adaptation of new statistical methodology in support of drug research and development, keeping current with regulatory guidance and requirements in the global environment.
A Master’s degree in Statistics, Mathematics, or related field; Ph.D. preferred.
Relevant clinical and pharmaceutical industry experience in the planning and conduct of clinical trials (preferably early human studies in a pharmaceutical industry setting).
Approximately 5+ years managing the internal and/or external Biostatistics team
Approximately 12+ years of related experience working in biotech/pharmaceutical industry. Proven history of effectively contributing to the business plan at both the tactical and strategic levels.
Ability to travel, in some cases, internationally. (Average travel expectations: <20%/year.)
REQUIRED KNOWLEDGE AND ABILITIES:
Extensive knowledge of GCP, ICH guidelines, FDA regulations, CDISC standards/implementation guides, 21 CFR Part 11, and familiarity with EMA/CHMP regulations and guidelines, and other international regulatory requirements; In-depth knowledge of the global drug development process.
eCTD NDA submission experience is a must
Advanced proficiency in Base SAS, SAS Macros, SAS/STAT, SAS/Graph, SAS/SQL and SAS/ODS and other relevant statistical software (eg. R).
Advanced understanding of the development, programming, management, validation and documentation maintenance of all programming tasks
Understands the sequence of running programs to ensure up-to-date data and to troubleshoot, debug programming problems and to identify data trends.
Ability to lead a team with regards to ongoing development both personnel development and departmental methodologies and techniques.
Appropriate computer software experience (including MS Word, Excel, PowerPoint, Project)
Manage multiple programs with competing and aggressive time lines, prioritize activities, and work independently; Able to work in a quickly changing, not fully structured internal and external environment.
Demonstrated problem solving skills (including taking ownership to ensure timely resolution), a strong sense of urgency, keen attention to detail, and the ability to successfully execute in an environment under time and resource pressures.
From: Intercept Pharmaceuticals