Biostatistician III : 4601430

Artech Information System LLC; East Hanover (NJ); On-site; USD 80,000 - 110,000; Full time

Job summary

A leading IT staffing company is seeking someone to provide statistical support for clinical trials. This role involves writing and reviewing statistical sections of study documents, developing statistical analysis plans, and ensuring quality deliverables. Candidates should have at least 5 years in pharmaceutical development, a strong background in clinical trials methodology, and experience using SAS. Fluency in English and strong communication skills are also required.

Qualifications

• At least 5 years experience in pharmaceutical development and clinical research.
• Sound statistical skills and knowledge of clinical trials methodology.
• Experience with SAS in the analysis and reporting of pharmaceutical data.

Responsibilities

• Support the Trial Statistician with statistical sections of study documents.
• Develop SAP and program TLFs ahead of database lock.
• Maintain effective communication with internal and external customers.

Skills

Statistical analysis

Clinical trials methodology

SAS programming

Database design

Oncology knowledge

Fluent English

Communication skills

Job description

Artech is the 10th Largest IT Staffing Company in the US, according to Staffing Industry Analysts' 2012 annual report. Artech provides technical expertise to fill gaps in clients' immediate skill-sets availability, deliver emerging technology skill-sets, refresh existing skill base, allow for flexibility in project planning and execution phases, and provide budgeting/financial flexibility by offering contingent labor as a variable cost.

Job Description

Support the Trial Statistician; Write and review statistical sections and other relevant parts of study synopses and protocols. Support study start up activities (including review of Data Handling plan, CRF review, study specific documentation)

Develop SAP, program TLFs, preparation for database lock, dry run and CSR activities; support analyses as required for decision making at project level; support analyses and activities during submission and response to HA questions.

Ensure timeliness and adequate quality of statistical deliverables.

Provide input as required at all meetings and activities related to set up of trials he/she will be assigned to

Maintain efficient interfaces with internal and external customers and communicate effectively across line functions.

• At least 5 years experience in pharmaceutical development and clinical research
• Sound statistical skills and knowledge of clinical trials methodology: experience with analysis planning and reporting of clinical trials
• Experience using SAS in the analysis and the reporting of pharmaceutical data
• Working knowledge of database design/structures
• Expertise with SAS (including SAS macro language)
• Experience in Oncology therapeutic area would be appreciated
• Fluent in English, good oral and written communication skills
• Knowledge and experience in reporting activities for Clinical Pharmacology trials preferred