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

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Job ID:

23079

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:

Director, Biostatistics

Job Description:

The Director of Biostatistics is responsible for providing direct supervision for one or more therapeutic area leader(s). He/She also provides direction on clinical development plans, protocols and analysis, reviews clinical study reports and regulatory submission materials, and ensures that standard procedures are followed within projects.

He/She provides mentorship to biostatisticians in the department. He/She is responsible for implementing consistent statistical conduct for the department in all s. He/She also provides guidance to the department towards achieving departmental and corporate visions and goals.

The Director maintains liaison with clinical research personnel in order to identify and meet their needs for statistical support. He/She interacts with head of statistical programming and data management to synchronize prioritization of projects and in some cases, he/she represents Biostatistics in meetings with executive committee, commercial, regulatory agencies, and external development partners.

*LI-RD2

Job Requirements:

Qualifications
- At least 10 years of Biotech or Pharmaceutical experience working in Biostatistics
- Broad and thorough understanding of statistical principles and clinical trial methodology, able to practice and implement them
- Ability to develop innovative/creative statistical/technical solutions to complex problems
- Knowledge and experienced in meeting regulatory guidance, both FDA and international regulatory agencies
- Broad knowledge of medical/biological terminology and clinical practice in relevant therapeutic areas
- Attentive to detail
- Able to write and present information effectively
- Effective communicator: able to explain methodology and consequences of decisions in lay terms, able to understand requests for complex analyses, etc.
- Able to manage many projects simultaneously, to manage conflicting priorities, and to be flexible when priorities change
- Able to manage staff
- Demonstrates excellent leadership and communication skills
- Demonstrates strong organizational skills, including the ability to prioritize.
- Past frequent interaction with FDA
- BLA/NDA experience essential
- Interaction with EMEA/CPMP and preparation of an MAA an advantage. EducationPhD in Biostatistics/Statistics or 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

Director, Biostatistics

col-narrow-left   

Job ID:

23079

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:

Director, Biostatistics

Job Description:

The Director of Biostatistics is responsible for providing direct supervision for one or more therapeutic area leader(s). He/She also provides direction on clinical development plans, protocols and analysis, reviews clinical study reports and regulatory submission materials, and ensures that standard procedures are followed within projects.

He/She provides mentorship to biostatisticians in the department. He/She is responsible for implementing consistent statistical conduct for the department in all s. He/She also provides guidance to the department towards achieving departmental and corporate visions and goals.

The Director maintains liaison with clinical research personnel in order to identify and meet their needs for statistical support. He/She interacts with head of statistical programming and data management to synchronize prioritization of projects and in some cases, he/she represents Biostatistics in meetings with executive committee, commercial, regulatory agencies, and external development partners.

*LI-RD2

Job Requirements:

Qualifications
- At least 10 years of Biotech or Pharmaceutical experience working in Biostatistics
- Broad and thorough understanding of statistical principles and clinical trial methodology, able to practice and implement them
- Ability to develop innovative/creative statistical/technical solutions to complex problems
- Knowledge and experienced in meeting regulatory guidance, both FDA and international regulatory agencies
- Broad knowledge of medical/biological terminology and clinical practice in relevant therapeutic areas
- Attentive to detail
- Able to write and present information effectively
- Effective communicator: able to explain methodology and consequences of decisions in lay terms, able to understand requests for complex analyses, etc.
- Able to manage many projects simultaneously, to manage conflicting priorities, and to be flexible when priorities change
- Able to manage staff
- Demonstrates excellent leadership and communication skills
- Demonstrates strong organizational skills, including the ability to prioritize.
- Past frequent interaction with FDA
- BLA/NDA experience essential
- Interaction with EMEA/CPMP and preparation of an MAA an advantage. EducationPhD in Biostatistics/Statistics or 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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