Biostatistician Level 3

Job Description

Statistician working on trial planning and analysis activities with review. Assists project statistician in preparing development programs for new drug indications. 

PRINCIPAL RESPONSIBILITIES: List major responsibilities and duties of the position. List most complex or difficult parts of job first. Describe scope of responsibilities. 

1. Provides primary statistical input for clinical study design. 

2. Provides analysis planning for clinical studies. 

3. Provides statistical input to clinical study reports. 

4. Assists in clinical development planning for new drug indications. 

5. Provides statistical support to other disciplines related to clinical statistics. 

6. Complies with department SOPs and regulatory guidance. 

RESPONSIBILITY FOR OTHERS (If applicable): Describe the nature of supervision exercised over others by this position. 

ADD RESPONSIBILITIES: 

PRINCIPAL RELATIONSHIPS: Describe the primary working relationships (internal & external) and primary interfaces. 

1. Biostatistics staff; Clinical Teams and associated working groups 

2. Contacts Inside the Company: Therapeutic area scientific staff; SAS Programming; Clinical data management; Clinical Trials Management; Regulatory Affairs; Clinical Communications; Clinical Pharmacology; Medical Writing, Quality Management 

3. Contacts Outside the Company: CRO staff; Regulatory Agencies; External Trial Committees 

Qualifications

EDUCATION AND EXPERIENCE REQUIREMENTS: 

1. Describe the minimum knowledge, skill and ability requirements for the position. Include any degrees or certifications which are required and/or desirable. 

2. Masters degree in Statistics or related field +2 years experience or PhD in Statistics or related field. 

3. Basic knowledge of SAS programming and at least some other significant statistical software (e.g., S-Plus, PASS). Demonstrated written and oral communication skills. Ability to work independently.

Additional Information

Thanks & Regards………. 

Sneha Shrivastava

Technical Recruiter (Clinical/Scientific)

Artech Information Systems LLC

360 Mt. Kemble Avenue, Suite 2000 | Morristown, NJ 07960

Office: 973.967.3348 | Fax: 973.998.2599

Website: www.artechinfo.com

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