Person2Person, LLC
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| Associate Director Biostatistics Based in Northern, NJ |
| Outstanding Contract opportunity with a global pharmaceutical Company focused on multiple therapeutic areas including Neurology, Oncology and Critical Care. They continue to move forward with an entry into biologics with the development of therapeutic antibodies and other such agents, which contributes to their innovate drug discovery process. Be a part of this global market leader! |
| SCOPE & DUTIES |
Outstanding Scientific opportunity with a biopharmaceutical company working to develop and deliver
life-changing therapies for a wide array of serious and life-threatening medical conditions. These include
hematologic and kidney diseases, transplant, other inflammatory disorders, and cancer. They are also
both evaluating other potential indications for Soliris, its first marketed product and pursuing the
development of other products from its deep pipeline of new biological entities. Be part of this exciting,
innovative Company!
Scope:
The Associate Director, Biostatistics will provide support for the Medical Affairs Department. He/she is a
skilled statistician with training and significant experience in Biostatistics, Drug Development, and
Clinical Research with a focus on statistical methodology appropriate for both clinical trials and secondary
analyses. He/she will provide statistical support for publications, presentations, posters at medical
meetings and any other requests not covered in the clinical study report, either personally or by
supervising one or more biostatisticians, working closely with statistical programmers. He/she will interact
with authors, referees, and internal reviewers in the preparation of publications, presentations and
posters, and provide statistical input into the proposed design and analysis of protocols.
Responsibilities:
Actively provide statistical support to the Medical Affairs Department.
Provide statistical support for publications, presentations, posters at medical meetings and any other
requests not covered in the clinical study report. This includes data mining, meta-analysis, and support
for data-driven analyses.
Interact with authors, referees and in-house reviewers in the preparation of publications, presentation
and posters.
Provide statistical input into study design and analysis for Company -sponsored studies and registries,
and provide statistical reviews of proposed design and analysis of investigator-sponsored protocols.
Keeps abreast of literature/advancements in science/medicine/technology in own and related fields of
the drug development program.
Monitors project progress and ensures proper resource allocation for successful project deliverables
against goals and timelines.
Work closely with other departments in the company (clinical, marketing, data management, health
economics, etc.) and provide statistical support for a variety of functional groups.
life-changing therapies for a wide array of serious and life-threatening medical conditions. These include
hematologic and kidney diseases, transplant, other inflammatory disorders, and cancer. They are also
both evaluating other potential indications for Soliris, its first marketed product and pursuing the
development of other products from its deep pipeline of new biological entities. Be part of this exciting,
innovative Company!
Scope:
The Associate Director, Biostatistics will provide support for the Medical Affairs Department. He/she is a
skilled statistician with training and significant experience in Biostatistics, Drug Development, and
Clinical Research with a focus on statistical methodology appropriate for both clinical trials and secondary
analyses. He/she will provide statistical support for publications, presentations, posters at medical
meetings and any other requests not covered in the clinical study report, either personally or by
supervising one or more biostatisticians, working closely with statistical programmers. He/she will interact
with authors, referees, and internal reviewers in the preparation of publications, presentations and
posters, and provide statistical input into the proposed design and analysis of protocols.
Responsibilities:
Actively provide statistical support to the Medical Affairs Department.
Provide statistical support for publications, presentations, posters at medical meetings and any other
requests not covered in the clinical study report. This includes data mining, meta-analysis, and support
for data-driven analyses.
Interact with authors, referees and in-house reviewers in the preparation of publications, presentation
and posters.
Provide statistical input into study design and analysis for Company -sponsored studies and registries,
and provide statistical reviews of proposed design and analysis of investigator-sponsored protocols.
Keeps abreast of literature/advancements in science/medicine/technology in own and related fields of
the drug development program.
Monitors project progress and ensures proper resource allocation for successful project deliverables
against goals and timelines.
Work closely with other departments in the company (clinical, marketing, data management, health
economics, etc.) and provide statistical support for a variety of functional groups.
| REQUIREMENTS |
PhD in Statistics/Biostatistics and at least 8 years of pharmaceutical experience.
The successful candidate must also possess the following: comprehensive knowledge of statistical
methodology in design and analysis, both for clinical studies and secondary analyses; experience
performing statistical analyses to support publications; working knowledge of major statistical software
programs including SAS; knowledge of CDISC requirements for SDTM and ADaM; thorough
understanding of statistical regulatory requirements and guidance documents; excellent verbal and
written communication skills, and excellent inter-personal skills. The qualified applicant must also be
flexible, well-organized, and have the ability to work well under pressure.
The successful candidate must also possess the following: comprehensive knowledge of statistical
methodology in design and analysis, both for clinical studies and secondary analyses; experience
performing statistical analyses to support publications; working knowledge of major statistical software
programs including SAS; knowledge of CDISC requirements for SDTM and ADaM; thorough
understanding of statistical regulatory requirements and guidance documents; excellent verbal and
written communication skills, and excellent inter-personal skills. The qualified applicant must also be
flexible, well-organized, and have the ability to work well under pressure.
| Executive Recruiting Specialists in the NY/NJ/CT Region |
Apply today! For immediate consideration, please email resume to: lsydor@person2personllc.com |