Biostatistician 3

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.

Skills:

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

Education:

Minimum Master in statistics

No C2C.

Qualifications

Minimum Bachelors/ Master in statistics

Additional Information

For more information, Please contact

Akriti Gupta

(973) 967-3409

Morristown, NJ 07960