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Lead Biostatistician. Job in Cambridge, Massachusetts, United States in Biogen. Nelest.com
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Lead Biostatistician

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Job ID:

23080

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:

Lead Biostatistician

Job Description:

The Lead Biostatistician is responsible for providing project leadership in Biostatistics for one or more specific company products or a therapeutic area as assigned. He/She participates in the development of standards across protocols in protocol development, analysis plans and file/report specifications. He/She also reviews CRFs and data edits and serves as lead biostatistician on one or more projects.

This person performs statistical analyses, interprets statistical results, and prepares clinical study reports including integrated summaries for submissions. He/She reviews analysis of other study statisticians participating on their project for accuracy, consistency, and quality output. He/She also addresses regulatory issues and/or issues from external development partners.

Job Requirements:

Qualifications
- MS with 6 or PhD with 4 years or more working on clinical trials
- Past interaction with FDA (preferred)
- BLA/NDA experience desired but not essential
- Interaction with EMEA/CHMP and preparation of an MAA an advantage Education
- MS or PhD in Biostatistics/Statistics and equivalent 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

Lead Biostatistician

col-narrow-left   

Job ID:

23080

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:

Lead Biostatistician

Job Description:

The Lead Biostatistician is responsible for providing project leadership in Biostatistics for one or more specific company products or a therapeutic area as assigned. He/She participates in the development of standards across protocols in protocol development, analysis plans and file/report specifications. He/She also reviews CRFs and data edits and serves as lead biostatistician on one or more projects.

This person performs statistical analyses, interprets statistical results, and prepares clinical study reports including integrated summaries for submissions. He/She reviews analysis of other study statisticians participating on their project for accuracy, consistency, and quality output. He/She also addresses regulatory issues and/or issues from external development partners.

Job Requirements:

Qualifications
- MS with 6 or PhD with 4 years or more working on clinical trials
- Past interaction with FDA (preferred)
- BLA/NDA experience desired but not essential
- Interaction with EMEA/CHMP and preparation of an MAA an advantage Education
- MS or PhD in Biostatistics/Statistics and equivalent 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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