Biostats Specialist 9/8/2016

Biotech/Pharma Company Berkeley Heights, NJ

Company
Biotech/Pharma Company
Job Classification
Full Time
Company Ref #
29678771
AJE Ref #
576120482
Location
Berkeley Heights, NJ
Job Type
Regular

JOB DESCRIPTION

APPLY
DETAILS:

JOB TITLE: BIOSTATS SPECIALIST

LOCATION: BERKELEY HEIGHTS, NJ

DURATION: 12 MONTHS

JOB DESCRIPTIONS:

Typical work schedule = 9am - 5pm, but slight flexibility with start/end times
Weekend work NOT required.
OT NOT required.

CORE JOB FUNCTIONS:
-- Work under the direction of Medical Affairs Statistics Disease Lead
-- Actively provide statistical support to the Medical Affairs Department for publications, presentations, posters and any other requests not covered in the clinical study report. This includes data mining, meta-analysis, and support for data-driven analyses.
-- Provide statistical input for study design, sample size calculation and CRF creation.
-- Review or create statistical analysis plan including table shells, analysis dataset specifications.
-- Write SAS programs and macros to generate data sets and TFLs.

Knowledge/Skills/Abilities (KSA's):

-- Masters or PhD in Statistics with a focus on statistical methods for clinical trials.
-- 3-5 years of experience in the planning, analysis and reporting of clinical trials.
-- Experience in oncology trials a plus
-- Good planning and project management skills.
-- Detailed knowledge of currently accepted statistical methodologies.
-- Excellent SAS skills including TFL generation.
-- Willingness to be hands-on when needed.
-- Knowledge of MS Office products (Word, Excel, PowerPoint)
-- Excellent communication, writing and organizational skills is essential.
-- Demonstrated ability to work in a team environment with clinicians, data managers, and medical writers.