Associate Director, Statistics - Virology & Metabolics
AbbVie - Lake County, IL

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Associate Director, Statistics - Virology & Metabolics - 13000001NW

Description
AbbVie (NYSE: ABBV) is a global, research-based biopharmaceutical company formed in 2013 following separation from Abbott. AbbVie combines the focus and passion of a leading-edge biotech with the expertise and capabilities of a long-established pharmaceutical leader to develop and market advanced therapies that address some of the world’s most complex and serious diseases. In 2013, AbbVie will employ approximately 21,000 people worldwide and markets medicines in more than 170 countries.

Primary Job Function:

Provides scientific and statistical leadership role through own efforts and those of their staff for drug discovery or development strategies; for

the design, analysis, and reporting of scientific research trials; and for interacting with regulatory agencies regarding the results of these

activities.

Core Job Functions:

Responsible for compliance with applicable Corporate and Divisional Policies and procedures.

Protocols Development:

Directs the development of scientific protocols, ensuring they are scientifically sound and make optimal use of the data to be collected

Ensures research hypotheses and corresponding study designs are aligned with the project strategy, and meet scientific and/or regulatory needs

Ensures statistical methodology is appropriate and sound, consistent with the objective(s) of the scientific protocol

Database Activities:

In collaboration with Data Sciences, Statistical Programming and other stakeholders, ensures data collection instruments are designed to capture protocol-specified scientific information and study databases (e.g., SAS, MS Access, Excel) are implemented such that short- and long-term project needs can be achieved

Oversees or partners in development of data quality assurance checks, ensuring accuracy and consistency of data released for statistical analysis

Statistical Analyses:

Demonstrates outstanding understanding of statistical concepts and methodologies

Proposes new/novel statistical methodological approaches leading to improvements in the efficiency and sensitivity of study results

Provides sufficient detail to allow programming implementation

Ensures that all the statistical analyses specified in scientific protocols and/or analysis plans are conducted appropriately

Scientific Reports and Publications:

Ensures that study results and conclusions are scientifically sound, clearly presented, and supported by the statistical analyses provided

Prepares oral and written reports to effectively communicate results of clinical/scientific research to AbbVie management, project teams, regulatory agencies, or individual investigators

Represents Data and Statistical Sciences (DSS) or Biometrics on project issues at management review meetings and project team meetings

Provides in-depth scientific/statistical review for scientific reports and publications

Ensures the accuracy of the statistical component of scientific reports and/or publications with high quality

Consultation:

Partners with multiple stakeholders to develop scientifically appropriate development strategies for one or more major drug discovery or development projects

Effectively plans and manages statistical resources to meet assigned project priorities

Works with Director and appropriate administrative staff to arrange for and manage alternative resources (i.e., consultants, CROs, interns, temporary staff) to satisfy needs of assigned projects

Interacts with relevant stakeholders to ensure that appropriate statistical methods are adequately and consistently applied in all scientific and regulatory documents, presentations, and publications

Provides scientific/statistical insight in addressing questions from clients, and proposes novel solutions to technical issues

Independently pursues analyses suggested by the data, including the pursuit of statistical knowledge needed to address the scientific issue

In collaboration with Statistical Programming or their designee, ensures that all internal and external statistical software used in the performance of analyses defined in SAPs or scientific research plans are efficient, validated, and meet internal SOPs and external regulatory requirements

Acts as the liaison for statistical issues on AbbVie collaborative studies with outside universities, government agencies, steering and/or data monitoring committees, joint ventures or licensing activities

Builds external scientific contacts which foster professional development and promote the reputation of the department

Demonstrates broad understanding of scientific research designs, worldwide regulatory requirements and commercial aspects of drug development

Critically reviews regulatory submission documents for one or more major drug discovery or development projects

Effectively and persuasively presents statistical concepts, evidence, interpretations, and logical arguments to the project team, management, regulatory and scientists

Project Team Involvement:

Partners with Clinical and Regulatory to develop scientifically appropriate development strategies for assigned projects

Represents DSS or Biometrics on project team(s) to provide functional area input to compound/drug development and ensures alignment with functional management

Leads the communication between assigned project team(s) and DSS/Biometrics functional area to ensure timely communication of project team updates, proper statistical strategies, and alignment of priorities between the project team and functional management

May represent DSS or Biometrics on data monitoring committees

Builds/drives inter-department relationships and teamwork

Training, Supervising, Mentoring:

In conjunction with Director, and/or administrative management, coordinates and supervises statistical support for the assigned drug discovery or development programs

Effectively mentors other development stakeholders with regards to statistical methodology and departmental operations

Manages personnel by appropriately delegating assignments, reviewing activities and defining and ensuring review of deliverables so that projects are completed on time with high quality

Stimulates the scientific development of staff

Develops and supervises departmental seminars, short courses, and the publication/presentation of scientific articles

Works with Director and/or administrative management to develop and arrange appropriate training opportunities for staff and facilitate their timely career development

Works with Director and/or appropriate administrative management to recruit qualified statisticians to the organization

Ensures that staff and self are compliant with training requirements

Demonstrates a high degree of responsibility in maintaining DSS / Biometrics standards, GxP compliance, and best operating practices for staff and self

Project Coordination / Regulatory Activities:

Plans and coordinates statistical resources to best meet project area priorities

Works with the Director and/or administrative management to ensure that drug discovery or development programs incorporate sufficient statistical/scientific rigor and quality to meet stated objectives and global regulatory requirements

Works with Director to build relationships between DSS / Biometrics and outside investigators and medical/scientific experts

Ensures that all applicable regulatory requirements for work processes are met

Participates in discussions with regulatory agencies as needed

Consistently demonstrates excellent record of achievement with respect to DSS / Biometrics and business objectives

Position Accountability and Scope:

With Director, accountable for providing proposals and assessments of scientific strategies; collaborating with representatives from various scientific and operational functions to ensure success of assigned drug discovery or development projects

Also responsible for management and development of assigned staff

Qualifications
Experience and Education Required:

For Associate Director, Statistics

M.S./Ph.D. in Statistics, Biostatistics or a related field

At least 6-10 yrs (PhD) or 12 -14 yrs (MS) experience in pharmaceutical development and applied statistics/statistical consulting with a minimum of 2 years of mentorship and/or management experience

Advanced knowledge of statistical methodology and global regulatory requirements, expertise in drug discovery or development, and an understanding of commercial

aspects of drug development

Must have demonstrated exemplary statistical experience in managing and completing multiple projects or equivalent experience

Experience in leading NDA, BLA, and or CTD submission preferred

Experience interacting with regulatory agencies highly desirable

Excellent communication skills, both oral and written

Jointly with other project team members, develops and evaluates options for meeting project team goals under time and budgetary

constraints

Proposes and evaluates options for responding to questions from internal and external sources, including regulatory agencies.

Implements the agreed upon solution after discussion with other stakeholders

Identifies opportunities for, and leads teams for process improvement initiatives

Actively participates in risk assessment and development of contingency plans

Productive in relevant statistical research and problem solving

For Assistant Director, Statistics

M.S./Ph.D. in Statistics, Biostatistics or a related field. At least 6-8 yrs (PhD) or 10-12 yrs (MS) experience in pharmaceutical development

and applied statistics/statistical consulting

Project lead experience required

Broad knowledge of statistical methodology and global regulatory requirements, expertise in drug discovery or development, and an understanding of commercial aspects of drug development

Experience interacting with regulatory agencies highly desirable

Excellent communication skills, both oral and written

Jointly with other project team members, develops and evaluates options for meeting project team goals under time and resource constraints

Proposes and evaluates options for responding to questions from internal and external sources, including regulatory agencies

Implements the agreed upon solution after discussion with other stakeholders.Identifies opportunities for, and leads teams for process improvement

initiatives

Actively participates in risk assessment and development of contingency plans

Productive in relevant statistical research and problem solving

Significant Work Activities and Conditions Continuous sitting for prolonged periods ( more than 2 consecutive hours in an 8 hour day)
Job Classification : Experienced
Job : CLINICAL RESEARCH
Primary Location : USA-Illinois-Lake County

Organization : GPRD-Pharma R&D
Schedule : Full-time
Shift : Day
Travel : Yes, 20 % of the Time

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