Biostatistician (AdvancedGroup_410556) Florham Park, New Jersey
Job Number: 410556
Designing clinical studies. Writing and reviewing statistical sections and other relevant parts of study synopses and protocols. Support study start up activities.
Develop RAP, program TLFs, preparation for database lock, dry run and CSR activities; review CRF, DB spec, VAP; support analyses as required for decision making at project level; support analyses and activities during submission and response to HA questions.
Coordinate study tasks with other statisticians and other line functions.
Ensure timeliness and adequate quality of statistical deliverables.
Follow processes, adhere to and project standards as well as Health Authority requirements.
At least 5 years experience in pharmaceutical development and clinical research
Strong statistical skills and knowledge of clinical trials methodology: experience with analysis planning and reporting of clinical trials Knowledge of SAS Fluent in English, good oral and written communication skills Experience in Oncology Good team player High degree of autonomy in performing assigned duties Able to establish personal relationships with personnel from other line functions Experience with intercultural teams
Minimum Master in statistics
Interested candidates please send resume in Word format to firstname.lastname@example.org Please reference job code 410556 when responding to this ad.