Grifols Shared Services North America, Inc Senior Director, Biostatistics and Data Management in Durham, North Carolina
Oversees all activities related to biostatistics, statistical programming, and data management in the Clinical Development Department and provides additional supports in electronic submission, pharmacokinetic, outcome research, and pharmacoeconomics area. Participates in the development, registration, and life cycle management of all Grifols products. Stakeholder in strategic discussions about new indications and development strategy. Provides leadership to the team in study design inputs, statistical analysis plans, reporting (tables, listings, and figures) standards, analysis data sets, the statistical portion of clinical study reports, and biometrical components compiled according to the requirements from the international regulatory agencies. Direct reports includes programming, data management team managers and biostatisticians.
● Oversees workflow and direction of projects related to statistics and data management in the clinical operation department for all clinical trials across all therapeutic areas (clinical trial design, execution, statistical analysis, reporting, and interpretation).
● Hires, mentors, manages employees across a diverse functional group consisting of statistics, statistical programming, and data management to support life-cycle management and new product development. Key innovator to support Medical Directors in strategic brainstorming of new clinical programs.
● Reviews documents generated from clinical data including clinical study reports, safety reports, data monitoring committee reports as well as protocols and amendments, investigator brochures.
● Adboard attendee with KOLs to probe clinical and statistical feasibility of new potential programs. Provide advice on the statistical considerations of study designs.
● Works with regulatory affairs to ensure the biometry department deliverable for preparation of electronic submissions to regulatory agencies.
● Accountable for pharmacokinetic methodology and analyses.
● Represents Grifols as the senior statistical expert at FDA or other international regulatory agency meetings to discuss methodological issues in the analysis of data or to support the understanding and rationalization of how data is planned to be or has been analyzed and or supports other biostatisticians who may be interfacing with regulatory agencies. Reacts to regulatory inquiries, questions with responses on trial data or study designs pertinent to biometry and/or oversees responses provided by other biostatisticians.
● Interacts with senior managers, medical directors, and study managers and other Grifols departments in exploring opportunities in new indications for Grifols products. Provides input into clinical/statistical feasibility of such new opportunities. Advises the business on probabilities of statistical success based on current known data and or literature.
● Ensures that deliverables for production of clinical trial data are met according to pre-defined timelines and that quality controls, validation and standard operating procedures are in place to ensure production of accurate results.
● Supervises multiple external contract research organizations (CRO’s) and independent consultants with different functionalities to support data management (including EDC and eCRFs), pharmacokinetic, pharmacoeconomic and other statistical needs of the business. Reviews data management documents including, but not limited to, CRFs, data management plan, database specifications, and edit checks adherences. Provides oversight for review of spend by multiple contractors to ensure within assigned budget. Assesses resources versus project needs and makes decisions on when to place workload with CROs versus manage a program with in-house resources. Assesses project timelines and advises the company on changes where necessary
● Provides the expertise in protocol development (sample size determination, study design, DMC, randomization strategies etc)and review and approval of those protocols and clinical study reports for which he/she is the lead. and regulatory submission documents (such as ISS, ISE, PSURs, and Package Inserts) generated by the clinical development department.
● Provides leadership in establishing, and maintaining policies, standards and guidances for the conduct of all aspects the biometric functions. and holds the biometry team accountable for quality deliverables based on these standards. Writes/revises the SOPs governing the statistics and data management activities to ensure compliance with regulatory requirements.
● Drives data evaluation, publication, and data presentation. Accountable for accuracy of all clinical data in all publications. Direct interaction with KOLs with regards to publications.
● Ensure processes, SOPs, and GCP/ICH adherence for statistics and data management activities.
● Provides resources as required to support other departments statistical needs. Internationally provides statistical support for key international projects ICON, Canada, GmBH. Develops new methodology or extends existing theory when demanded by complex problems.
● Provides training to the department personnel pertinent to the new trend and methodologies in statistics and data management activities as applied in clinical trial.
Knowledge, Skills, and Abilities:
Expert knowledge of a wide range of statistical methodology, including experimental design, linear models, mixed models, categorical data techniques, nonparametric statistics, and survival analysis. Expert knowledge of advanced statistical and probability theory. Expert knowledge of regulatory guidelines related to trial design, analysis, reporting, data structure, and electronic submissions. Broad knowledge of clinical trials and the statistical applications in clinical trials. Strong knowledge of ICH GCP and FDA guidelines. Broad knowledge of medical background to be able to communicate with medical personnel regarding the statistical issues arising in the clinical trials. Solid skills in computer programming (especially SAS). Strong communication and interpersonal skills. Strong writing skills to author regulatory reports. Strong presentational, analytical, problem-solving, and active learning skills. Strong organizational, documentation, and information gathering skills. Ability to manage internal and external personnel to support all clinical trials. Ability to multi-task and work across several different therapeutic areas at a given time. Ability to defend statistical methodology to regulatory agencies.
Broad Knowledge in data management activities including case report form design, electronic data capture, coding and data cleaning activities.
Ph.D. degree in statistics, biostatistics, or related field. Typically requires a minimum of 13 years of experience in biostatistics and/or clinical data management, including at least 10 years managing/supervising experience in biostatistics or data management.
Work is performed in an office environment with exposure to electrical office equipment. Frequently sits for 6-8 hours per day. Repetitive hand movement of both hands with the ability to make fast, simple, repeated movements of the fingers, hands, and wrists. Frequently walks. Occasionally bends and twists neck. Light to moderate lifting and carrying objects with a maximum lift of 25lbs. Frequently drives to site locations and frequently travels within the United States. Able to communicate complex information and ideas so others will understand; with the ability to listen to and understand information and ideas presented through spoken words and sentences. Frequently interacts with others, relates sensitive information to diverse groups. Ability to apply abstract principles to solve complex conceptual issues. Performs a wide range of complex tasks as dictated by variable demands and changing conditions with little predictability as to the occurrence.
Req ID: 265367