Carleton Southworth, MS, RAC

Carleton Southworth, MS, RAC

South Bend, IN and St. Louis, MO (574) 367-8078 (574) 551-9273 (Mobile)

SUMMARY

·  In-depth biostatistical and data analysis experience

·  Recent hands-on experience in regulatory affairs, biostatistics, quality assurance

·  Demonstrated ability to support PMA submissions (pre-clinical and clinical)

·  Familiar with FDA and EMEA guidance, experience interacting with FDA

·  Uncommonly strong writing and problem solving skills

·  Contributions to clinical trial, biostatistics, orthopedic and neurosurgical literature

·  Medical device inventor (orthopedic and neurosurgical)

·  Ability to work independently and proactively in multidisciplinary teams

·  Experience with multiple drug/devices

·  Proficient in SAS, Minitab, and familiar with R

·  Case report form design experience

·  Experienced in: Ortho, CV, CNS, biologics, spine, combination drug/device

EDUCATION

AB Psychology, Cum Laude, Vassar College, Distinction for Exceptional Research awarded

MS I/O Pysch., Univ. of Tenn. Knoxville, instructor Management Science Department

Ph.D. course work complete, Univ. of Tenn., Knoxville (Ph.D. not completed)

EMPLOYMENT HISTORY

Inventiv Health 2013-Present

Biostatistics Consultant

·  In vitro diagnostic statistical support

·  Comprehensive biostatistical support for cutting-edge IVDs

American Research Partners, LLC

Director Biostatistics and Regulatory Affairs 2010-Present

(Functional service provider providing services to multiple companies)

·  Statistical support for regulatory submissions and peer reviewed articles

·  Cardiovascular / Biotech interventions

·  Regulatory strategy and submission consulting

·  Protocol development

·  Process validation and improvement

DePuy, Inc. (Johnson & Johnson; Neuro and Orthopaedic products)

Manager Biostatistics (hands-on working manager) 2006 – 2010

·  Supervise international team of four biostatisticians and a senior technical writer

·  Responsible for statistical support of four PMA applications

·  Genetic marker predictive validity

·  Responsibilities of Project Leader Biostatistics position

Project Leader Biostatistics and Data Management 2004 – 2006

·  Responsible for developing a database that captures DePuy clinical outcomes

·  Spearhead effort to publish and present DePuy clinical results

·  Statistical lead for computer aided surgery, hip and trauma products

·  Provide statistical support to Product Development and Emerging Technologies groups

·  Assist in the design and analysis of international clinical studies

·  Supervisory responsibilities

·  Responsibilities of Biostatistician III position

Project Leader Biostatistics and Outcomes Research 2000 – 2004

·  Supervised up to four direct reports, including non-exempt and professional employees

·  Contributed to the development of methods designed to collect healthcare reimbursement data

·  Assisted in selecting and validating Oracle Clinical (part 11 compliant software)

·  Responsibilities of Biostatistician III position

Biostatistician III 1999 – 2000

· 

·  Analysis plans and protocols for IDEs and studies of commercial products

·  PMA and 510k statistical reports (primarily using SAS)

·  Provide statistical analysis, editorial assistance and write peer reviewed articles

·  Interface with FDA and answer questions pertaining to submissions

·  Software selection and evaluation

·  Provide statistical support for several drug/device and biologic products including the PROSTALAC hip (now commercially distributed).

·  Support Quality Assurance and R & D with respect to experimental design and statistical analysis requirements

Johnson & Johnson Professional, Inc.

Sr. Clinical Research Associate 1994-1999

·  Designed, conducted and analyzed the results of a clinical trial for an image-guided surgical navigation system for neurosurgery. This included writing the protocol (and developing the measurement system for assessing system accuracy), designing the database (in Access), analyzing the results in SAS, writing all statistical reports for submission to the FDA, monitoring the study, and controlling the inventory of investigational devices. The product was approved for commercial distribution sooner than expected.

·  Provided technical support to neurosurgeons and R & D professionals for peer reviewed publications in neurosurgery and othopaedics

·  Supported a combination Drug/Device (Monitoring, statistical analysis, reports to FDA, created clinical databases in Medlog and Access, managed clinical inventory)

·  Supported QA and R & D with respect to experimental design and statistical analysis

Codman and Shurtleff (Johnson & Johnson)

Sr. Regulatory/Clincial Affairs/Biostatistician 1991-1994

Sr. Quality Engineer 1989-1991

·  Wrote 510ks, interfaced with FDA, participated in all aspects of clinical study management

·  Evaluated engineering changes with approval authority; determined whether a 510k was needed

·  Statistical Quality Assurance including statistical process controls for injection molding

·  Wrote guidance documents for upper management on reimbursement, software validation, and preproducation quality assurance

·  Developed a process control system that identified improperly milled silicone elastomer, saving money and possibly preventing a recall

·  Supported the Bactiseal shunt (a combination drug-device) in the following capacities; protocol development, database design and creation, site initiation, site monitoring, investigational device inventory management including distribution and accounting, FDA interface and reporting

Sikorsky Aircraft, United Technologies (Aerospace)

Quality Systems Engineer/Statistician 1987-1988

·  Process Validation; Statistical QA & SPC (machining, plating). Initiated a machine tool capability study, saving $450,000.00; created division-wide policies and procedures

·  Wrote a statistical report in connection with a multi-billion dollar recall

George W. Moore, Inc (High Volume Machined Products)

Quality Control Manager 1986-1987

·  Saved #1 account by controlling critical dimension with an innovative use of SPC; responsible for customer correspondence, MRB, and supervising set-up and production inspectors

Cambridge Machined Products (Medical Device Components)

Quality Department Manager 1985

·  Responsible for all aspects of quality assurance. Supervised seven inspectors. Audited suppliers and interfaced with medical component and automotive component customers

TECHNOLOGY

·  Statistical Analysis Software: SAS/STAT, SAS/GRAPH, SAS/BASE, Minitab

·  Microsoft Word (with Visual Basic), Microsoft EXCEL, PowerPoint

·  Computer Operating Systems including: MS Windows

·  Psychometrics (questionnaire design)

GRADUATE LEVEL QUANTITATIVE COURSES

Statistics I

Statistics II

Statistics III

Experimental Design I

Experimental Design II

Quasi-Experimental Design

Quantitative Employee Selection

Multivariate Statistics

Program Evaluation (Quantitative Methods)

Psychometrics

Statistical Software (SAS, SPSS, BMDP)

In addition to these courses, which were specifically aimed at teaching quantitative methods, many other courses were taken in the field of industrial and organizational psychology aimed at teaching practical uses for applied statistics. The entire program was aimed at approaching industrial psychology from a quantitative perspective. Experimental design applied to field research, the design of instruments intended to collect subject self-reported data, and statistical methods for analyzing results were emphasized in this program.

Formerly certified as a quality engineer (CQE); 830th individual in the country to attain certification in regulatory affairs (RAC).

PARTIAL LIST OF SEMINARS ATTENDED

Payment for Drugs, Devices, and Biotechnology

GMP Overview

Preproduction Quality Assurance

Monitoring Clinical Trials

Remote Study Monitoring

Software and Medical Devices

HIMA Seminar on Regulatory Compliance

Biostatistics (one week advanced course with Karl Peace, instructor)

Writing IDEs and Conducting Clinical Studies

Bayesian Statistics

Sample Size Determination with nQuery Advisor

Seminar on Estimating Survival Curves

Transition to Management from a Technical Role

Transition to Management

ISO Training

DIA Data Management

DIA Reimbursement

JOURNAL REVIEWER

Peer reviewer for Clinical Orthopaedics and Related Research 2006 - Present.

JOURNAL EDITOR

Editorial board member, The Investigator Sponsored Trials Journal

AWARDS

Johnson & Johnson Global Leadership Profile Award 2007

Johnson & Johnson Standards of Leadership Award 2006

Innovation Day – Winning Team Member 2003

CLINICAL TRIALS

·  PCR Studies

·  bioNexia Rapid Tests

·  Vitek-MS

·  Bactiseal

·  Hakim Programable Shunt

·  Acustar

·  S-ROM/ZZT Cup

·  TruMatch

·  Multi-center knee navigation

·  Single-center knee navigation

·  Anchor-Peg glenoid

·  Bone substitute

·  Nerve stimulation study (pilot)

·  Total ankle study

·  Restore (SIS) study

·  HA hip study

·  Extended ROM knee study

·  Pinnacle hip study

·  Trilock hip

·  C-stem hip

·  Analgesic study

·  Antibiotic device

·  Artificial disc

·  Aneurysm coil

·  Global shoulder

·  CTA Head

·  Minimally invasive knee

·  Minimally invasive hip

·  Surface replacement hip

·  Ceramic on Cermic hip

·  Artificial spinal disc

·  Genetic marker

·  Hyaluronic Acid

PRESENTATIONS AND PUBLICATIONS

Southworth, Carleton. Making Sense of Biostatistics: Outliers in Clinical Data. Journal of Clinical Research Best Practices. Vol. 8, No. 6, June 2012.

Southworth, Carleton. Optimizing Sample Size. Journal of Clinical Research Best Practices. Vol. 8, No. 6, June 2012.

Southworth, Carleton. Making Sense of Biostatistics: Randomization. Journal of Clinical Research Best Practices. Vol. 8, No. 4, April 2012.

Wirth M, Loredo R, Garcia G, Rockwood C, Southworth C, Iannotti J. Total shoulder arthroplasty with an all-polyethylene pegged bone-ingrowth glenoid component: a clinical and radiographic outcome study. JBJS 2012;94:260-267.

Southworth, Carleton; Close, Nicole; Nichols, Thomas. Biostatistics for mere mortals. Presentation at MAGI’s Clinical Research Conference, Las Vegas, NV, October 23-26 2011.

Southworth, Carleton (program chair); Bowman, Clawson; Cooper, Jeffrey. Investigational Device Exemption (IDE) applications. Presentation at MAGI’s Clinical Research Conference, Las Vegas, NV, October 23-26 2011.

Southworth, Carleton. Study Registration Loopholes. Journal of Clinical Research Best Practices. Vol. 7, No. 7, July 2011.

Carothers, Joshua; Kim, Raymond; Dennis, Douglas; Southworth, Carleton. Mobile Bearing Total Knee Arthroplasty: A Meta-Analysis. Journal of Arthroplasty, Vol. 26, Issue 4, 537-542, 2011.

Southworth, Carleton. Bringing a new product to market and beyond: when and how statisticians can grease the chute by reducing uncertainty. Presentation at The MWDG of the ASQ Biomedical Division Meeting, University of Indianapolis, April 28, 2011.

Wirth, Michael; Loredo, Rebecca; Garcia, Glenn; Southworth, Carleton. Clinical and radiographic evaluation of a tussue-ingrowth glenoid component. Scientific Presentation. The Texas Orthopaedic Association 2010 Annual Meeting, April 22-24, 2010.

Moradi, Babak; Kertzner, Michael; Dela Rosa, Mylene; Southworth, Carleton; Vail, Thomas; Schmalzried, Thomas. Patient Characteristics Influence Total Hip and Hip Resurfacing Outcomes. Poster No. 105, New Orleans, AAOS 2010 Proceedings.

Kindsfater, Kirk; Barrett, William;Dowd, James; Zovkic, Vesna; Southworth, Carleton. Midterm Survival of a Multi-Liner Acetabular Cup: 1593 Consecutive Total Hip Replacements. E-Poster No. 400, Vienna, 10th EFORT Congress, 2009.

Boese, CK, Gruen, TA, Spitzer, AI, Gorab, RS, Southworth, CB, Cassell, MJ, Suthers, K. Cemented triple-tapered polished femoral stems: intermediate multicenter study results. Israeli Orthopaedic Association Proceedings: Tel Aviv, December 19-20, 2006. Published in Journal of Bone and Joint Surgery (British) 2008, Issue SUPP_III, 506, 90-B: 506-b.

Dowd, James; Kindsfater, Kirk; Barrett, William; Southworth, Carleton; Dalury, David. Large Femoral Heads can Help Reduce Risk of Dislocation in Total Hip Arthroplasty. The Journal of Arthroplasty, Volume 23, Issue 2, February 2008.

Dowd, James; Kindsfater, Kirk; Barrett, William; Southworth, Carleton; Dalury, David. Large Femoral Heads can Help Reduce Risk of Dislocation in THR. Podium No: 060, San Francisco California, AAOS 2008 Proceedings.

Wirth, Michael; Southworth, Carleton; Larsen, Mitchell; Fox, Joel; Rockwood, Charles. The Effect of Anatomical Reconstruction Following HA for Proximal Humerus Fractures. Podium No: 011, San Francisco California, AAOS 2008 Proceedings.

Dowd, James; Kindsfater, Kirk; Barrett, William; Southworth, Carleton; Dalury, David. Large Femoral Heads can Help Reduce Risk of Dislocation in THR. Paper No. 13, Dallas Texas, AAHKS 17th Annual Meeting 2007.

Kindsfater, Kirk; Barrett, William; Dowd, James; Southworth, Carleton; Cassell, Marilyn. Midterm Survival of the Pinnacle Multi-Liner Acetabular Cup in a Prospective Multi-Center Study. Poster No. PO77, San Diego, California, AAOS 2007 Proceedings.

Barrett, William; Kindsfater, Kirk; Dowd, James; Southworth, Carleton. Delayed Hypersensitivity in Total Hip Replacement with Metal-On-Metal Bearings. Poster No. 4, San Diego, California, Western Orthopaedic Association’s 71st Annual Meeting 2007.

Wirth, Michael; Ondrla, Jeff; Southworth, Carleton; Kaar, Ken; Anderson, Brett C.; Rockwood, Charles A. Replicating Proximal Humeral Articular Geometry with a Third Generation Implant: A Radiographic Study in Cadaveric Shoulders. The Journal of Shoulder and Elbow Surgery. Vol. 16, No 3S, 2007.

Wirth, Michael; Tapscott, Stacy; Southworth, Carleton; Rockwood, Charles. Treatment of Glenohumeral Arthritis with a Hemiarthrplasty, Surgical Technique. The Journal of Bone and Joint Surgery (American) 89:10-25. 2007.

Wirth, Michael; Lim, Moon Sup; Southworth, Carleton; Laredo, Rebecca; Kaar, Ken; Rockwood, Charles A. Compaction Bone Grafting in Prosthetic Shoulder Arthroplasty. The Journal of Bone and Joint Surgey (American) 89:49-57, 2007.

Wirth, Michael; Tappscott, Stacy; Southworth, Carleton; Rockwood, Charles. Treatment of glenhumeral arthritis with a hemiarthroplasty: a minimum five-year follow-up outcome study. The Journal of Bone and Joint Surgery (American). 88:965-973; May 2006.

Wirth, Michael; Southworth, Carleton; Rockwood, Charles. Mid-term Results of Hemi-Arthroplasty versus Total Shoulder Arthroplasty: 5 year Minimum Follow-up. Paper No. 280, Chicago Illinois, AAOS 2006 Proceedings.

Wirth, Michael; Rockwood, Charles; Southworth, Carleton; Swenning, Todd. Mid-term Results of Treating Glenohumeral Arthrosis with a TSA: A 5 – 10 Year Outcome Study. Paper No. 281, Chicago Illinois, AAOS 2006 Proceedings.

Jacobs, Michael; Gorab, Robert; Mattingly, David; Trick, Lawrence; Southworth, Carleton. 3-6 Year Results of a Prospective Randomized Study Using an S-ROM Stem and a Metal-on-Metal Articulation for Primary Hip Replacement. J. Arthroplasty Feb; 19(2): 260, 2004.

Masri, B.A., Duncan, C.P., Wentworth, S., Southworth, C. PROSTALACâ (PROSthesis of Antibiotic Loaded Acrylic Cement) Hip Temporary Prosthesis System. 69th Annual Meeting Proceedings AAOS, Feb. 13-17, Dallas, Texas 2002.

Lazarus, M.D., Jensen, K.L., Southworth, C., Matsen, F.A. The Radiograpnic Evaluation of Keeled and Pegged Glenoid Component Insertion. The Journal of Bone and Joint Surgery (American). Vol. 84-A No.7 pp. 1174-1182, July 2002.

Wentworth, S.J., Masri, B.A., Duncan, C.P., Southworth, C. B. Hip Prosthesis of Antibiotic-Loaded Acrylic Cement for the Treatment of Infections Following Total Hip Arthroplasty. The Journal of Bone and Joint Surgery (Supplement) Page 123-128 NDN- 224-0343-1569-8. December 2002.

Rockwood, C.A., Tapscott, S., Southworth, C.B., Wirth, M.A. The Long Term Results of Treating Glenohumeral Arthrosis with a Hemiarthroplasty: A 5 – 10 year Outcome Study. Pebble Beach, October 2002.

Ondrla, J., Wirth, M., Kaar, K., Southworth, C., Rockwood C. Replicating Proximal Humeral Articular Geometry: A Radiographic Study in Normal Shoulders. 8th International Congress on Surgery of the Shoulder, Apr. 23-26, Cape Town, South Africa, 2001.

PUBLICATIONS WITH ACKNOWLEDGMENT OF CONTRIBUTION

Johal, H., Buckley, R., Le, I., Leighton, R. A Prospective Randomized Controlled Trial of a Bioresorbable Calcium Phosphate Paste (α-BSM) in Treatment of Displaced Intra-Articular Calcaneal Fractures. The Journal of Trauma. Vol. 67, No. 4, Oct. 2009.