Executive Director, Biostatistics and Data Management

Intercept Pharmaceuticals   •  

San Diego, CA

Industry: Pharmaceuticals & Biotech


11 - 15 years

Posted 242 days ago

This job is no longer available.

Executive Director, Biostatistics and Data Management

Job ID:  428
Job Location:  San Diego (La Jolla), CA 
Job City:  San Diego 
Date Updated:  April 19, 2018

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The Executive Director, Biostatistics and Data Management will have overall responsibility and accountability of Biostatistics, Statistical Programming and Clinical Data Management across the portfolio as it relates to all stages of development including the clinical related components of regulatory submissions, either Clinical Trial Applications or New Drug Applications, to Post-marketing activities. This position represents Biostatistics on the clinical and project teams across the company’s portfolio, providing subject matter expertise and strategic direction to the Clinical programs. The Sr. Director/ Executive Director of Biostatistics and Data Management is expected to provide oversight and supervision of relevant external consultants and clinical research organizations, primarily as it relates to external data management, statistical and programming work; Supervise internal and external Biostatistics, Programming, and/or Clinical Data Management personnel to analyze and present data based on agreed-to specifications. He/she will develop, create, verify/validate and maintain all programs for assigned projects in compliance with standard operating procedures. The Sr. Director / Executive Director of Biostatistics and Data Management is also responsible for cross functional standardization and harmony, technology and process improvement and resource forecasting. Liaise with non-clinical and pre-clinical teams regarding the conduct of experiments, statistical methodology, data analysis and interpretation, and regulatory issues.
To perform this job successfully an individual must be able to perform each essential function satisfactorily.
• 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
o Identify and manage appropriate statistical consultants to assist with research programs
• Assume responsibility for the preparation of data management, statistical, and statistical programming components of all regulatory submissions; Ensure that all activities are conducted in compliance and relevant regulatory requirements 
• Provide Biostatistics subject matter expertise to the clinical and projects teams as appropriate; Liaise withnon-clinical and pre-clinical teams regarding the conduct of experiments, statistical methodology, data analysis and interpretation, and regulatory issues.

• Provide statistical oversight of other company Biostatisticians as appropriate.
• Facilitate and maintain communication between Clinical Data Management and cross-functional areas toinclude Clinical Research, Clinical Operations, Biostatistics, 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 data management, statistical, and statistical programming activities associated with clinical research studies across all stages of development and with programs leading to regulatory submissions.
o Review clinical study protocols, providing statistical feedback and input on project design issues, endpoint definition and sample sizes; Provide sample size calculation and documentation 
o Assign and manage resource to meet overall and critical project deliveries; Supervise all Biostatistics-related work conducted by relevant external consultants and clinical research organizations
o Review Case Report Forms to ensure data is collected appropriately to achieve the analysis defined in the protocol 
o Write and/or review Statistical Analysis Plans including Mock tables, listings and figures; Review programming specifications
o Ensure table, listing, figure and statistical analysis programming is being done according to specifications. 
o Create and maintain analyses, tables/listings/figures
o Perform programming validation and ensures all Quality Control efforts have been followed
• Provide guidance into development and implementation of data management and statistical programming standards and ensures that the standards are followed; Evaluate Clinical Data Management software and provide input on selection, development and implementation.
• Define, drive and prepare (or supervise preparation of) statistical strategic and quantitative contributions toregulatory/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).
• 5+ years managing the Biostatistics, Statistical Programming and Clinical Data Management 
• 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.)
• 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 
• Manage multiple programs with competing and aggressive time lines, prioritize activities, and workindependently; 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.