Principal Statistician

Organization
AbbVie
Job Location
Redwood City, CA
Job Description

AbbVie (NYSE:ABBV) is a global, research-based biopharmaceutical company formed in 2013 following separation from Abbott. 
AbbVie Biotherapeutics (ABR) is AbbVie's Center of Innovation in Oncology Research and Development, located in Redwood City, CA. ABR employs approximately 160 individuals in the San Francisco Bay Area. Its size and entrepreneurial work force allow for effective cross-functional collaboration, agility, and rapid decision making.
ABR research and development efforts are focused on two key areas: 
•Immuno-Oncology (I-O), which activates the immune system to recognize and eliminate cancer cells 
•Antibody drug conjugates (ADCs) that allow for potent toxins to be delivered directed to cancerous cells while sparing healthy tissues
AbbVie Data and Statistical Sciences (DSS), consisting of Statistics, Statistical Programming and Data Sciences, is a key function that plays important roles in drug development. 
ABR is currently looking for an Assistant Director, Statistics, reporting to the Director, Statistics/DSS Site Head at ABR. 
Key Responsibilities: 
Provides scientific and statistical expertise through own efforts and those of her/his staff (if appropriate) for development strategies and execution to advance pipeline programs. This typically includes partnering with functional and cross functional team members in the creation of clinical development plans, and having primary strategic and operational responsibilities for the design, conduct, and evaluation of experiments/clinical studies. In conjunction with Director/ABR DSS site head, he/she will coordinate statistical support for development projects in the pipeline.
Clinical Development: 
•Serves as the lead statistician on cross-functional project and clinical teams, providing statistical and strategic input into Clinical Development Plans and target product profiles.
•Leads the effort in developing innovative trial designs that are aligned with the project strategy, and applies scientific rigor to methods of analysis and interpretation results.
•Reviews study protocols, authors statistical sections of protocols, develops statistical analysis plan and analysis specification for programming implementation.
•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 are implemented such that short- and long-term project needs can be achieved.
•Oversees or partners in the development of data quality assurance checks, ensuring accuracy and consistency of data releases for statistical analysis.
•Develops statistical programs as necessary to perform analyses, reviews and approves analyses produced by statistical programming.
•Provides in-depth scientific/statistical review for scientific reports and publications, and ensures the accuracy of the statistical component of scientific reports and/or publications with high quality.
•Provides analytical and strategic leadership for exploratory activities such as biomarker development, and due diligences.
•Manages CROs to ensure quality deliverables are completed within pre-determined timeline and budget. 
Functional Area: 
•Participates in and contributes to scientific/statistical seminars and review forums.
•Contributes to the improvement and standardization of global functional processes and procedures.
•Builds external scientific contacts which foster professional development and promote the reputation of the department.
•Leads the communication between assigned project team(s) and DSS functional area to ensure timely communication of project team updates, proper statistical strategies, and alignment of priorities between the project team and functional management.
•Mentors other development stakeholders with regards to statistical methodology and departmental operations.
•Mentors and/or manages personnel when appropriate. 
•Works with Director and/or appropriate administrative management to recruit qualified statisticians.



Requirements: 



Basic: 
•Ph.D. in Statistics or Biostatistics with 8+ years of experience in Biopharmaceutical R&D or other relevant background in clinical research.
•Up-to-date expertise/knowledge in advanced statistical methodologies related to clinical trial designs, statistical modeling and data analyses, biomarker analysis. 
•Excellent oral and written communication skills. 
•Should have Therapeutic Area experience in Oncology for minimum of 2 year.
•Experience in early clinical development is desirable
•Assistant Director: experience in direct managing or supervising staff for minimum of 2 years 
•Principal Statistician: experience in direct supervising/mentoring junior staff is desirable
Experience and/or Competencies Required: 
•Excellent knowledge and experience in applying statistical methods to drug development.
•Profound knowledge of GCP, regulations, guidelines and their application to drug development.
•Proficient communication and collaboration skills (including statistical consulting skills, interpersonal skills to contribute effectively in cross-functional team settings, ability to influence others without authority, ability to build strong collaborative relationships with scientific and non-scientific partners).
•Excellent project management skills (including ability to manage scope and effectively to delegate to staff, contractors, external vendors, and other functions when appropriate).
•Proficient strategic agility (including problem-solving and critical thinking skills, ability to drive and/or influence drug development strategies). 
•Excellent drive for results (demonstrates interest and ability to learn fast, grasps the 'essence', and adapt quickly when indicated, takes initiative, welcomes problems as challenges and finds solutions to technical problems).
•Learns fast, grasps the 'essence' and can change the course quickly where indicated
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, opens to suggestions and experimentation for improvement
•Embraces the ideas of others, nurtures innovation and manages innovation to reality

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