Requisition ID 14631BR
Title Sr. Director, Biostatistics
Job Category Medical Information
Job Description PURPOSE:
Position is responsible for leadership of the Biostatistics function within US based Novo Nordisk subsidiary (NNI). This is a technical position with heavy managerial responsibilities. The incumbent is responsible for the delivery of every aspect of statistical support to NNI’s clinical development, registration, and marketing of new drugs. This is a highly independent position sustained by the training, experience, and judgment of the incumbent. Activities are to be coordinated with project priorities and project team decisions. Serve as the technical leader in all aspects of biostatistics and statistical programming across all NNI clinical programs.
RELATIONSHIPS:
This position reports to the VP, Scientific Analytics & Communications– works closely with clinicians, medical writers, data managers, regulatory managers, and marketing managers. Externally, interacts with and maintains updated information about relevant regulate agencies, particularly the FDA, and other relevant organizations. Directly supervises statisticians and statistical programmers.
ESSENTIAL FUNCTIONS:
CLINICAL TRIAL DESIGN AND ANALYSIS:
Guides and participates in the review of study protocols, critique and suggest improvements on scientific methodology, writes statistical sections, develops plans for statistical analysis and presentation.
Guides department staff to proactively participate in clinical development projects. Assures that statistical and scientific methodologies are fully considered and documented.
Guides the interaction with medical development, medical writing, regulatory affairs, and regulatory agencies. Assures statistical input, analysis, and reports of the highest quality are delivered according to schedule.
CUSTOMER MANAGEMENT:
Manages relations with NNI internal customers, including clinicians, medical writers, marketing managers, as well as similar functions at headquarters.
Manages relations with regulatory agencies (primarily the FDA).
QUALITY AND PROCEDURE IMPROVEMENT:
Keeping abreast and observing general guidance established in the pharmaceutical industry, including FDA guidelines, ICH guidelines, NN SOPs, and generally accepted GCP.
Leads department staff keeping abreast with current statistical literature. Assures the most current regulatory requirements are followed and sound methodologies are adopted.
Participates in the development and update of internal SOPs and working procedures.
RESOURCE MANAGEMENT:
Leadership of biostatistics staff.
Manages the interactions with NN A/S headquarters statistical group.
Workload management – including prioritization, task assignments, timeline management, and outsourcing management.
STATISTICAL PROGRAMMING AND PRESENTATION:
Provides input into the development and maintenance of statistical routine libraries. Assures efficient use of resources and talents.
Works through data management, assures that data listing, tables, and graphs are produced with the highest efficiency and quality.
PHYSICAL REQUIREMENTS:
Approximately 20% (including international) overnight travel
DEVELOPMENT OF PEOPLE:
Ensure that reporting personnel have necessary performance review plans with annual goals and measurements that are consistent with the priorities of the business, and that interim reviews are held so that their work is focused on those priorities, and they understand their level of accountability for results and the measurement process.
Ensure that the IDP forms include completed Learning and Aspiration plans and are in place for all reporting personnel to enable the achievement of goals and capability to assume increased levels of responsibility.
Manage the application and communication of all Novo Nordisk policies, procedures, and Novo Nordisk Way.
KEY SUCCESS FACTORS: EDUCATION, EXPERIENCE, KNOWLEDGE AND SKILLS
Advanced degree in Biostatistics, Statistics, or related areas (Ph.D. preferred).
At least 12 years of experience in the pharmaceutical industry engaged in the biostatistical support of clinical development, with progressively increasing scope and level of responsibility.
Excellent communication, interpersonal and organization skills.
Excellent leadership skills.
Extensive knowledge of regulatory requirements.
Extensive knowledge of statistical concepts and techniques and of clinical trial principles.
Department CMR - BIOSTATISTICS & STATISTICAL PROG
Position Location US - Princeton, NJ
City Princeton
State/Provinces US - NJ
Degree Required Master's Degree Required
Percent Travel 20 - 30%
Title Sr. Director, Biostatistics
Job Category Medical Information
Job Description PURPOSE:
Position is responsible for leadership of the Biostatistics function within US based Novo Nordisk subsidiary (NNI). This is a technical position with heavy managerial responsibilities. The incumbent is responsible for the delivery of every aspect of statistical support to NNI’s clinical development, registration, and marketing of new drugs. This is a highly independent position sustained by the training, experience, and judgment of the incumbent. Activities are to be coordinated with project priorities and project team decisions. Serve as the technical leader in all aspects of biostatistics and statistical programming across all NNI clinical programs.
RELATIONSHIPS:
This position reports to the VP, Scientific Analytics & Communications– works closely with clinicians, medical writers, data managers, regulatory managers, and marketing managers. Externally, interacts with and maintains updated information about relevant regulate agencies, particularly the FDA, and other relevant organizations. Directly supervises statisticians and statistical programmers.
ESSENTIAL FUNCTIONS:
CLINICAL TRIAL DESIGN AND ANALYSIS:
Guides and participates in the review of study protocols, critique and suggest improvements on scientific methodology, writes statistical sections, develops plans for statistical analysis and presentation.
Guides department staff to proactively participate in clinical development projects. Assures that statistical and scientific methodologies are fully considered and documented.
Guides the interaction with medical development, medical writing, regulatory affairs, and regulatory agencies. Assures statistical input, analysis, and reports of the highest quality are delivered according to schedule.
CUSTOMER MANAGEMENT:
Manages relations with NNI internal customers, including clinicians, medical writers, marketing managers, as well as similar functions at headquarters.
Manages relations with regulatory agencies (primarily the FDA).
QUALITY AND PROCEDURE IMPROVEMENT:
Keeping abreast and observing general guidance established in the pharmaceutical industry, including FDA guidelines, ICH guidelines, NN SOPs, and generally accepted GCP.
Leads department staff keeping abreast with current statistical literature. Assures the most current regulatory requirements are followed and sound methodologies are adopted.
Participates in the development and update of internal SOPs and working procedures.
RESOURCE MANAGEMENT:
Leadership of biostatistics staff.
Manages the interactions with NN A/S headquarters statistical group.
Workload management – including prioritization, task assignments, timeline management, and outsourcing management.
STATISTICAL PROGRAMMING AND PRESENTATION:
Provides input into the development and maintenance of statistical routine libraries. Assures efficient use of resources and talents.
Works through data management, assures that data listing, tables, and graphs are produced with the highest efficiency and quality.
PHYSICAL REQUIREMENTS:
Approximately 20% (including international) overnight travel
DEVELOPMENT OF PEOPLE:
Ensure that reporting personnel have necessary performance review plans with annual goals and measurements that are consistent with the priorities of the business, and that interim reviews are held so that their work is focused on those priorities, and they understand their level of accountability for results and the measurement process.
Ensure that the IDP forms include completed Learning and Aspiration plans and are in place for all reporting personnel to enable the achievement of goals and capability to assume increased levels of responsibility.
Manage the application and communication of all Novo Nordisk policies, procedures, and Novo Nordisk Way.
KEY SUCCESS FACTORS: EDUCATION, EXPERIENCE, KNOWLEDGE AND SKILLS
Advanced degree in Biostatistics, Statistics, or related areas (Ph.D. preferred).
At least 12 years of experience in the pharmaceutical industry engaged in the biostatistical support of clinical development, with progressively increasing scope and level of responsibility.
Excellent communication, interpersonal and organization skills.
Excellent leadership skills.
Extensive knowledge of regulatory requirements.
Extensive knowledge of statistical concepts and techniques and of clinical trial principles.
Department CMR - BIOSTATISTICS & STATISTICAL PROG
Position Location US - Princeton, NJ
City Princeton
State/Provinces US - NJ
Degree Required Master's Degree Required
Percent Travel 20 - 30%