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Assoc Director, Biostatistics. Job in Cambridge, Massachusetts, United States in Biogen. Nelest.com
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Assoc Director, Biostatistics

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Job ID:

23078

Location:

Cambridge, MA 

Job function:

Information Systems Management
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Posted:

03.11.2016

Employment Type:

Full time

Industry:

Healthcare / Pharma
col-wide   

Title:

Assoc Director, Biostatistics

Job Description:

The Associate Director, Biostatistics is responsible for providing the statistical expertise for all company products within a therapeutic area, including response to statistical issues arising in regulatory or other legal settings, and may include addressing issues from external development partners.

This person provides mentorship to biostatisticians in the department. He/She maintains liaison with clinical research personnel in order to identify and meet their needs for statistical support and his/her strategy and results are reviewed by the Director, Biostatistics. He/She also contributes to the long-term growth strategy of the department.

Job Requirements:

Qualifications
- Broad and thorough understanding of statistical principles and clinical trial methodology, and the ability to practice and implement them
- Ability to develop innovative/creative statistical/technical solutions to complex problems
- Broad knowledge of medical/biological terminology and clinical trial designs in relevant therapeutic areas
- Attentive to detail
- Able to write and present information effectively
- Conversant with SAS programming, and detailed knowledge of SAS procedures and other statistical software
- Able to manage many projects simultaneously, to manage conflicting priorities, and to be flexible when priorities change
- Effective communicator: able to explain methodology and consequences of decisions in lay terms, able to understand requests for complex analyses, etc. Education
- MS with 8 or PhD with 6 years or more working on clinical trials
- Past frequent interaction with FDA and BLA/NDA experience
- Interaction with EMEA/CPMP and preparation of an MAA preferred About BiogenBiogen (NASDAQ: BIIB) is a biotechnology leader that discovers, develops and delivers innovative therapies to improve the lives of patients with neurodegenerative diseases, hematologic conditions and autoimmune diseases. Patients worldwide benefit every day from our medicines for multiple sclerosis (MS) and hemophilia.

Founded in 1978, Biogen is one of the world's oldest biotechnology companies. Our development pipeline is focused on areas of high unmet medical need, as we pursue new therapies for patients suffering from diseases with few or no treatment options. These include programs for secondary progressive MS, Alzheimer's Disease, spinal muscular atrophy, lupus and amyotrophic lateral sclerosis (ALS), amongst others.

With approximately 7,500 people worldwide, Biogen is truly a global organization. We are headquartered in Cambridge, Massachusetts, which is home to our research operations. Our international operations are based in Zug, Switzerland and we have world-class manufacturing facilities in North Carolina and Denmark. We offer therapies globally through direct affiliate presence in 30 countries and a network of distribution partners in over 50 additional countries.

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability or protected veteran status.

Please be advised that all legitimate correspondence from a Biogen employee will come from '@biogen.com' or '@biogenidec.com' email accounts.

Zip Code:

02142

Company Info
Biogen

Cambridge, MA, United States

Phone: +1 781-464-3260, +1 781-464-3260
Web Site: www.biogene.com

Company Profile

Company Info


Biogen
Cambridge, MA, United States
Phone: +1 781-464-3260, +1 781-464-3260
Web Site: www.biogene.com

Assoc Director, Biostatistics

col-narrow-left   

Job ID:

23078

Location:

Cambridge, MA 

Job function:

Information Systems Management
col-narrow-right   

Posted:

03.11.2016

Employment Type:

Full time

Industry:

Healthcare / Pharma
col-wide   

Title:

Assoc Director, Biostatistics

Job Description:

The Associate Director, Biostatistics is responsible for providing the statistical expertise for all company products within a therapeutic area, including response to statistical issues arising in regulatory or other legal settings, and may include addressing issues from external development partners.

This person provides mentorship to biostatisticians in the department. He/She maintains liaison with clinical research personnel in order to identify and meet their needs for statistical support and his/her strategy and results are reviewed by the Director, Biostatistics. He/She also contributes to the long-term growth strategy of the department.

Job Requirements:

Qualifications
- Broad and thorough understanding of statistical principles and clinical trial methodology, and the ability to practice and implement them
- Ability to develop innovative/creative statistical/technical solutions to complex problems
- Broad knowledge of medical/biological terminology and clinical trial designs in relevant therapeutic areas
- Attentive to detail
- Able to write and present information effectively
- Conversant with SAS programming, and detailed knowledge of SAS procedures and other statistical software
- Able to manage many projects simultaneously, to manage conflicting priorities, and to be flexible when priorities change
- Effective communicator: able to explain methodology and consequences of decisions in lay terms, able to understand requests for complex analyses, etc. Education
- MS with 8 or PhD with 6 years or more working on clinical trials
- Past frequent interaction with FDA and BLA/NDA experience
- Interaction with EMEA/CPMP and preparation of an MAA preferred About BiogenBiogen (NASDAQ: BIIB) is a biotechnology leader that discovers, develops and delivers innovative therapies to improve the lives of patients with neurodegenerative diseases, hematologic conditions and autoimmune diseases. Patients worldwide benefit every day from our medicines for multiple sclerosis (MS) and hemophilia.

Founded in 1978, Biogen is one of the world's oldest biotechnology companies. Our development pipeline is focused on areas of high unmet medical need, as we pursue new therapies for patients suffering from diseases with few or no treatment options. These include programs for secondary progressive MS, Alzheimer's Disease, spinal muscular atrophy, lupus and amyotrophic lateral sclerosis (ALS), amongst others.

With approximately 7,500 people worldwide, Biogen is truly a global organization. We are headquartered in Cambridge, Massachusetts, which is home to our research operations. Our international operations are based in Zug, Switzerland and we have world-class manufacturing facilities in North Carolina and Denmark. We offer therapies globally through direct affiliate presence in 30 countries and a network of distribution partners in over 50 additional countries.

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability or protected veteran status.

Please be advised that all legitimate correspondence from a Biogen employee will come from '@biogen.com' or '@biogenidec.com' email accounts.

Zip Code:

02142
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