Job Post: Biostatistician/Director of Biostatistics

Job Post: Biostatistician/Director of Biostatistics for a Contract Research Organization (CRO)

Location: variable

-Client facing
-Experience with FDA submissions – NDA, INDs
-3 plus years of Biostats experience in a pharma/CRO
-experience in Phase I,II, III clinical trials
-experience with CDISC
-PhD preferred

Contact: paul.s.kim@us.ibm.com

BioSpace Pharm Country Career Fair

Looking for a job in the biotech or pharmaceutical industry? How about with a contract research organization or CRO?

BioSpace Pharm Country Career Fair
Radisson Valley Forge
Tuesday, May 21, 2013
11am - 4pm

Learn more here.

Pharmacovigilance service providers

You don't have to work in a major pharmaceutical company to gain experience working in pharmacovigilance. There are a number of pharmacovigilance service providers that will employ health care professionals who are looking for non-clinical jobs in the area of pharmacovigilance.  Here's a list of some of those companies (many of these companies are also contract research organizations or CROs):

    * 4G Pharmacovigilance LLP
    * Akos
    * Chiltern
    * Fulcrumpharma
    * ii4sm International Institute for the Safety of Medicines
    * Parexel
    * Pharm-Olam International
    * PrimeVigilance
    * QSI
    * Quintiles
    * Synowledge LLC
    * BioSoteria, Inc.
    * PharSafer
    * BPI Service GmbH

This list can be found on Wikipedia here.

Top 10 Contract Research Organizations

Here's what Wikipedia has to say about Contract Research Organizations (CROs):

A Contract Research Organization, also called a Clinical Research Organization, (CRO) is a service organization that provides support and/or services for clinical trials. CROs support the pharmaceutical, biotech and medical device industries as well as foundations, research institutions, and universities, in addition to governmental organizations (such as the NIH, EMEA, etc.). There are over 1,100 CROs in the world. It is a very fragmented industry with the top 10 controlling 56.1% of the market in 2008. One estimate had the size of the market set to reach $24 billion in 2010 and set to grow at a rate of 8.5% through 2015.

Top 10 CROs:

1. Quintiles ($2.5 billion)[2][6]
2. Covance ($1.8 billion)[2][6]
3. Pharmaceutical Product Development (PPD) ($1.4 billion in sales)[2][7]
4. Charles River Laboratories (CRL) ($1.2 Billion sales)[6]
5. Parexel ($930 million in sales)[6]
6. ICON ($887 million)[8]
7. Kendle ($590 million in sales) [6]
8. Pharmanet ($470 million in sales)[6]
9. PRA International ($410 million in sales)[6]
10. Aptuit ($370 million in 2009)[6]

Featured physician executive: Silvia Zieher, M.D.

Each week, we feature a physician executive. This week's featured physician executive is Dr. Silvia Zieher.

Silvia Zieher, MD
Executive Director, Clinical Development, Latin America
INC Research, Inc.

Dr. Zieher has 15 years experience in clinical research as clinical team leader, clinical development manager of a top ten pharmaceutical company in Argentina and as a CRO clinical research director and head of clinical operations for Latin America. She joined the CRO industry in 2004.

Her responsibilities have included operations and project leadership activities related to the conduct of global clinical trials and the implementation of studies in Latin America. She has had direct line management responsibility of project teams. She has contributed to the development of training, quality control activities and development of processes and SOPs at the regional and global level. She has served as the the local safety officer with pharmacovigilance responsibilities for a pharma country affiliate. Dr. Zieher contributed to the preparation of the PAHO (Pan American Health Organization) guidelines: titled: “GCP: Document of the Americas” that was published in 2005, being the FIFARMA (Latin America Global Pharma industry) representative of the GCP expert working group at PANDRH (Pan American Network for Drug Regulatory Harmonization). This guideline is the foundation of all new regulations in Latin America. She has conducted academic activities in clinical research and is a frequent presenter as international conferences as DIA.

Prior to entering the pharmaceutical industry, she worked for 8 years as a pediatric physician public and private institutions in Buenos Aires, Argentina, and taught at the Faculty of Medicine of the University of Buenos Aires, where she also completed postgraduate studies in clinical pharmacology.

Clinical Data Manager (CDM)

Do you know anyone who is currently working as a Clinical Data Manager (CDM)? What is a CDM? We live in a world of acronyms that are so difficult to remember unless you work in that specific industry. If you don't work in clinical research and data management, then you may not be familiar with terms such as CDM, CRO, CCDM, GCP, CRA, CRC, GCDMP, etc.

Here are a few job descriptions that I copied from some recent CDM job postings:

The Clinical Data Manager is a key position in Clinical Data Management leading large / global projects, or multiple projects with responsibility for the development of the project Data Management Plan, data management systems set-up, and data accession, data entry and data review specifications and processes, and oversight of data management activities for the delivery of clinical data according to client quality and integrity specifications, project timelines and budgets. The Clinical Data Manager will develop and maintain a close liaison with project client contacts, core team members, and Project Managers to drive the data management aspects of project delivery.

Here's another job description:

Clinical Data Manager works collaboratively with Clinical Operations, Biometrics, PVG, Regulatory and other staff to meet project deliverables. The successful candidate will also have the ability to gather, organize, and analyze clinical data from multiple data sources. The incumbent will provide oversight to CROs, while performing extensive hands-on Clinical Data Management activities from protocol design through regulatory submission. This position will offer the ability to work in a stable and well-established company while also having a high level of visibility.

If you're interested in learning more, you may want to take a look at the Society for Clinical Data Management. Here's a little blurb about that organization:

The Society for Clinical Data Management was established in 1994 to advance the discipline of clinical data management and promote excellence and quality among clinical data managers and related professionals.

Today, SCDM has more than 2,600 members and is considered the industry leader in professional development resources. We are increasingly an international organization - our members currently represent nearly 40 countries outside North America.

Our Certified Clinical Data Manager (CCDM®) program sets the standard for quality in clinical research labs across the United States and around the world. Our Good Clinical Data Management Practices (GCDMP) establishes best practices for all facets of clinical data management and is the resource of choice for CDM professionals.

To learn more about the SCDM, visit: http://www.scdm.org

Fundamentals of Clinical Research

The Association of Clinical Research Professionals (ACRP) has a two-day course coming up. It's called: Fundamentals of Clinical Research

Sept. 10-11, 2009, Houston, TX
Oct. 15-16, 2009, Alexandria, VA

Fundamentals of Clinical Research is designed for those who aspire to the following roles: clinical research professionals managing studies at clinical research sites or monitoring studies, product managers, clinical investigators, institutional review board members, clinical pharmacologists, and research pharmacists.

Here are the learning objectives (you can receive continuing education credits):

* Discuss the main historical events which led to the increasing regulation of the development of medicinal products, devices and biologics
* Explain the differences in the development processes for medicinal products, devices and biologics
* Identify the roles and responsibilities of clinical research professionals in the overall process of conducting a clinical trial and how each professional contributes to that process
* Apply the principles of Good Clinical Practice (GCP) in their daily functions
* Identify the main regulations which govern the practice of clinical research
* Observe the additional rules applicable to research funded by the Federal government and bodies like the NCI and NIH
* Identify ethical issues involved with conducting clinical research
* Identify the protections given to human subjects in research
* Describe the process of obtaining informed consent from human subjects
* Describe the respective roles and responsibilities of clinical research professionals notably Clinical Research Coordinators (CRCs), and Clinical Research Associates (CRAs)
* Identify and evaluate Unanticipated Problems
* Define the criteria for reporting unanticipated problems and adverse events

If you're interested in pursuing a career in clinical research, then you may want to evaluate your skills and competencies based on the learning objectives listed above. How well can you explain/identify/describe/discuss/etc. each of the points listed above?

For more information about this course, click here.

Contract Research Organizations or CROs

If you're interested in a career in clinical research that's outside of academia, you may want to start with a CRO. There are many Contract Research Organizations (CROs) that work on various types of research projects for pharmaceutical and biotechnology companies (and even for the government). You often find these companies scattered throughout the country (and all over the world). Why would you want to work in a CRO? To gain exposure to a wide variety of therapeutics. Also, working in a CRO can also be a springboard to a career in pharma/biotech.

You may have heard of some of these companies:

• ACORN
• Advanced Biologics
• Averion
• Clinical Research Consulting
• MDCI
  
• MDS Pharma Services
• PPD (Pharmaceutical Product Development, Inc. - not the Tuberculosis skin test)
• RCRI
• Synteract
  
• And many more
  

CROs also also called Clinical Research Organizations (CROs). According to Wikipedia, "Services offered by CROs include: product development, formulation and manufacturing; clinical trial management (preclinical through phase IV); clinical, medical and safety monitoring; preclinical, toxicology, and clinical laboratory services for processing trial samples; data management, biostatistics and medical writing services for preparation of an FDA New Drug Application (NDA), Abbreviated New Drug Application (ANDA), or Biologics License Application (BLA); regulatory affairs support; and many other complementary services."