Manager, Statistics

Posted on Dec 12, 2018 by AbbVie

Ashburnham, MA 01430
Research & Development
4 Dec 2018
Annual Salary
Full-Time
Exploratory Statistics is part of the Data and Statistical Sciences (DSS) organization in AbbVie R&D. This group provides statistical expertise globally for various groups in drug discovery, development sciences and for biomarker & genomics studies in early to late-stage clinical trials. Examples of applications/topics supported include PD biomarker evaluations, biomarkers for clinical trials patient selection and enrichment, biomarker-based subgroup identification, in-vitro screening, in-vivo pharmacology, genomics (high-throughput mRNA expression arrays, CGH arrays, next generation sequencing, microRNA, genotype data, etc.), proteomics, and other biomarker data generated from pre-clinical and clinical studies.

Key Responsibilties:

Provides scientific and statistical expertise through own efforts and those of her/his staff (if appropriate) for drug discovery or development strategies for assigned project; for the design, analysis, and reporting of scientific research trials; and for interacting with regulatory agencies regarding the results of these activities.

Protocol 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 extensive 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 assigned drug discovery or development project
Effectively plans and coordinates statistical resources to best meet assigned project priorities
Works with Director and appropriate administrative staff to manage alternative resources (i.e., consultants, CROs, interns, temporary staff) to satisfy needs for assigned project
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 good understanding of scientific research designs, worldwide regulatory requirements and commercial aspects of drug development
Critically reviews regulatory submission documents for assigned drug discovery or drug development project
Effectively and persuasively presents statistical concepts, evidence, interpretations, and logical arguments to the project team, management, regulatory agencies, and scientists

Project Team Involvement:

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

Training, Supervising, Mentoring:

In conjunction with Associate Director and/or Director, coordinates statistical support for assigned drug discovery or development project
Effectively mentors other development stakeholders with regards to statistical methodology and departmental operations
Mentors and/or manages personnel when appropriate by delegating assignments, reviewing activities and defining/ensuring review of deliverables so that projects are completed on time with high quality
Fosters the scientific development of staff
Participates in department seminars, short courses, and the publication presentation of scientific articles
Works with Associate Director and/or Director to arrange training opportunities for staff to facilitate their timely career development
Works with Director and/or appropriate administrative management to recruit qualified statisticians to the organization
Ensures that staff (if appropriate) 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 (if appropriate) and self

Project Coordination / Regulatory Activities:

Coordinates statistical resources within and across sites to effectively utilize resources
Reviews key decisions impacting project timelines with department management
Has a strategic focus on assigned drug discovery or development project and optimizes execution
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 will be hired based on level of experience

Manager Statistics:

MS or PhD in Statistics, Biostatistics or a highly related field
At least 2-4 years (PhD) or 6-8 years (MS) of experience in pharmaceutical development and applied statistics/statistical consulting required
High degree of technical competence and effective oral and written communication skills
Competent in experimental design, descriptive and inferential statistics, biometrics/biopharmaceutical applications and computer programming
Pharmaceutical or related industry experience with nonclinical, clinical or pharmacology studies, as appropriate, including experience and understanding of drug development in the regulated environment preferred

Key Leadership Competencies:

Builds strong relationships with peers and cross functionally with partners outside of team to enable higher performance
Learns fast, grasps the 'essence' and can change the course quickly where indicated
Raises the bar and is never satisfied with the status quo
Creates a learning environment, open to suggestions and experimentation for improvement
Embraces the ideas of others, nurtures innovation and manages innovation to reality

Equal Opportunity Employer Minorities/Women/Veterans/Disabled

Reference: 599254488