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Associate Director, Clinical Statistics

AbbVie

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Location:
Chicago, IL
Posted Date:
7/29/2014
Position Type:
Full time
Job Code:
13000001NW
Salary:
Required Education:
Bachelors Degree
Areas of Expertise Desired:

Job 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

 

 



 


 


 


 


 


 



 


 


 


 


 




 

 



 


 


 


 


 


 


 



 


 


 


 


 


 


 



 


 


 


 


 


 

 



 


 




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Requirements

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



 


 


 



 


 

 



 



 


 


 

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