JEFFREY DAVIDSON
Downingtown, PA · 267.400.0219 · jeffyourstatguy@gmail.com
www.linkedin.com/in/jeffreyadavidson
BIOSTATISTICS CONSULTANT
Knowledgeable statistician with extensive experience leading Biometric teams in approvals for numerous indications across many therapeutic areas. In-depth knowledge in NDA, BLA and Device Registration within agency guidelines and standards of trial design and analysis. Recognized for handling missing data and adaptive solutions. Technical skills: SAS, PASS, nQuery, JMP, EAST. Core competencies:
Statistical Design and Analysis · DMC Representation · Regulatory Support · FDA Advisory Committee Representation ·
Cross-Functional Team Leader · Clinical Trials · Data Management · SOP · GCP · Drug Development
EXPERIENCE
ALPHA KAPPA STATISTICS, LLC, Downingtown, PA 2018 – Present
Chief Executive Officer (CEO)
Provide consulting to pharmaceutical companies to enhance products to market across multiple therapeutic areas. In-depth knowledge in clinical plan development, data monitoring committees, Ad Comms, FDA interaction and SOP development.
ENDO PHARMACEUTICALS, Malvern, PA 2015 – 2018
Vice President, Biometrics
Provided leadership to the clinical programming, data management, and biostatistics functions. Led all biometric activities, leading to product submissions to regulatory authorities. Hired, engaged and retained individuals and teams to include training and mentoring. Oversaw and maintained an annual budget.
ACCENTURE (formerly Octagon Research Solutions), Berwyn, PA 2009 – 2015
Senior Director, Clinical Statistics
Developed and led the department providing statistical consultancy to clients in the life sciences to include companies developing applications in the following areas of specialty: pharmaceuticals, devices and biotech.
Led DMC activities as independent and DMC statistician. Planned for capacity, maximizing utilization of staff on projects to maintain profitability goals.
ACI CLINICAL, Bala Cynwyd, PA 2007 – 2009
Senior Vice President, Biostatistics and Scientific Communications
Oversaw the Statistics, Data Management, Programming and Medical Writing functions. Developed and implemented offshore production processes and quality metrics.
SHIRE DEVELOPMENT, INC., Chesterbrook, PA 2004 – 2007
Vice President, Global Biometrics
Organized new international department across all biostatistical, programming and data management activities for NDA life cycle, as well as for supporting post-marketing and commercial needs. Department composed of 17 members (13 U.S., 4 UK). Managed budget and staffing while ensuring total quality.
PURDUE PHARMA, LP, Stamford, Ct 1998 – 2004
Director of Electronic Documents and Graphic Services, 2001 – 2004
Selected to lead a newly formed department, overseeing quality assurance, formatting, and electronic publishing of all regulatory submission documents. Managed a budget, resource planning and deployment.
Director of BSP (Biostatistics and Statistical Programming), 2000 - 2001
Director of BCDM (Biostatistics and Clinical Data Management), 1998 – 2000
Directed the efforts of the Biostatistics group, phases I-IV. Managed the resource planning, budget determination, hiring, mentoring, outsourcing efforts. Managed a department that ranged in size from 30 – 60 full time employees.
ADDITIONAL RELEVANT EXPERIENCE
KNOLL PHARMACEUTICALS, Mt. Olive, NJ
Manager of Statistics
HOFFMANN-LA ROCHE, Nutley, NJ
Director, Medical Affairs Biometrics
EDUCATION
Ph.D. – Measurements Evaluations and Techniques of Experimental Research (METER),
University of Pennsylvania
Master of Science – Special Education (MS), College of New Jersey
Bachelor of Arts – Psychology (BA), Penn State University
PROFESSIONAL MEMBERSHIPS
American Statistical Association
Downingtown, PA · 267.400.0219 · jeffyourstatguy@gmail.com
www.linkedin.com/in/jeffreyadavidson
BIOSTATISTICS CONSULTANT
Knowledgeable statistician with extensive experience leading Biometric teams in approvals for numerous indications across many therapeutic areas. In-depth knowledge in NDA, BLA and Device Registration within agency guidelines and standards of trial design and analysis. Recognized for handling missing data and adaptive solutions. Technical skills: SAS, PASS, nQuery, JMP, EAST. Core competencies:
Statistical Design and Analysis · DMC Representation · Regulatory Support · FDA Advisory Committee Representation ·
Cross-Functional Team Leader · Clinical Trials · Data Management · SOP · GCP · Drug Development
EXPERIENCE
ALPHA KAPPA STATISTICS, LLC, Downingtown, PA 2018 – Present
Chief Executive Officer (CEO)
Provide consulting to pharmaceutical companies to enhance products to market across multiple therapeutic areas. In-depth knowledge in clinical plan development, data monitoring committees, Ad Comms, FDA interaction and SOP development.
ENDO PHARMACEUTICALS, Malvern, PA 2015 – 2018
Vice President, Biometrics
Provided leadership to the clinical programming, data management, and biostatistics functions. Led all biometric activities, leading to product submissions to regulatory authorities. Hired, engaged and retained individuals and teams to include training and mentoring. Oversaw and maintained an annual budget.
- Ensured SOP development and adherence.
- Interacted with regulatory authorities.
- Represented Biostatistics at FDA Ad Comm.
ACCENTURE (formerly Octagon Research Solutions), Berwyn, PA 2009 – 2015
Senior Director, Clinical Statistics
Developed and led the department providing statistical consultancy to clients in the life sciences to include companies developing applications in the following areas of specialty: pharmaceuticals, devices and biotech.
Led DMC activities as independent and DMC statistician. Planned for capacity, maximizing utilization of staff on projects to maintain profitability goals.
- Clinical trial design, sample size determination, preparation of randomization schedules; statistical analysis, interpretations of statistical results, and preparation of statistical sections for clinical study reports.
- Evaluated and recommended appropriate statistical methods for data analysis.
- Provided support for applications to regulatory authorities.
- Advised clients in all dealings with statistical issues as they pertain to submission and approval activities during the entire life-cycle of product development.
- Supporting post-marketing strategy and implementation.
- Maintained SOPs to ensure they reflected state-of-the-art methods and current regulatory practice.
- Ensured adherence to departmental and company sops, developing and implementing process improvements.
ACI CLINICAL, Bala Cynwyd, PA 2007 – 2009
Senior Vice President, Biostatistics and Scientific Communications
Oversaw the Statistics, Data Management, Programming and Medical Writing functions. Developed and implemented offshore production processes and quality metrics.
- Managed clinical trial design including selection of appropriate statistical methods and tests; sample size calculations and preparation of randomization schedules; development and execution of statistical analysis; interpretations of statistical results, and preparation of statistical sections for clinical study reports; evaluated and proposed new statistical methods for data analysis.
- Ensured accurate statistical method sections for inclusion in study protocols; ensured proper design and content of Case Report Forms, database designs, and data edit checks; ensured validated SAS programs to support statistical analyses; ensured proper biostatistician documentation (including descriptions of methods, SAS programs and results) was maintained.
- Reviewed and audited statistical analysis plans, SAS programs, and statistical reports including tables, listings, and figures.
SHIRE DEVELOPMENT, INC., Chesterbrook, PA 2004 – 2007
Vice President, Global Biometrics
Organized new international department across all biostatistical, programming and data management activities for NDA life cycle, as well as for supporting post-marketing and commercial needs. Department composed of 17 members (13 U.S., 4 UK). Managed budget and staffing while ensuring total quality.
- Implemented best practices to ensure compliance with regulatory authorities; mentored staff and ensured the use of state-of-the-art methods in the design and analysis of clinical trials.
- Selected to represent biostatistics in direct discussions with FDA for NDA review questions.
- Represented sponsor at FDA advisory committee meeting (Daytrana, Dec 2005).
- Led biostatistics efforts resulting in approval of Fosrenol, ® Equetro, ® and Daytrana®. Oversaw 2 NDA filings in 2006, both of which were approved by the FDA in 2007.
PURDUE PHARMA, LP, Stamford, Ct 1998 – 2004
Director of Electronic Documents and Graphic Services, 2001 – 2004
Selected to lead a newly formed department, overseeing quality assurance, formatting, and electronic publishing of all regulatory submission documents. Managed a budget, resource planning and deployment.
- Contributed to process improvement efforts throughout Medical Research Department.
- Led the Medical Research department transition to use of Documentum® for life cycle management of all regulatory submission documents, ensuring version control and 21CFR part 11 compliance.
Director of BSP (Biostatistics and Statistical Programming), 2000 - 2001
Director of BCDM (Biostatistics and Clinical Data Management), 1998 – 2000
Directed the efforts of the Biostatistics group, phases I-IV. Managed the resource planning, budget determination, hiring, mentoring, outsourcing efforts. Managed a department that ranged in size from 30 – 60 full time employees.
- Led process change, SOP review, and revision.
- Oversaw the adherence to ICH guidelines as they relate to Biostatistics.
ADDITIONAL RELEVANT EXPERIENCE
KNOLL PHARMACEUTICALS, Mt. Olive, NJ
Manager of Statistics
HOFFMANN-LA ROCHE, Nutley, NJ
Director, Medical Affairs Biometrics
EDUCATION
Ph.D. – Measurements Evaluations and Techniques of Experimental Research (METER),
University of Pennsylvania
Master of Science – Special Education (MS), College of New Jersey
Bachelor of Arts – Psychology (BA), Penn State University
PROFESSIONAL MEMBERSHIPS
American Statistical Association