Senior / Principal Statistical Programmer
Cambridge, MA
Array:
Array BioPharma Inc. is a biopharmaceutical company located in Boston, MA, Morrisville, NC and Boulder, CO and
is focused on the discovery, development and commercialization of targeted small molecule drugs to treat
patients afflicted with cancer. Array’s most advanced programs include three cancer drugs, binimetinib (MEK162 /
wholly-owned), encorafenib (LGX818 / wholly-owned) and selumetinib (AstraZeneca). These three products are
currently advancing in a total of 6 pivotal trials, with top-line results expected in 2015 from both the NEMO
(binimetinib monotherapy in NRAS mutant melanoma patients) and SUMIT (selumetinib with dacarbazine in uveal
melanoma patients) Phase 3 trials. With these exciting developments, we have new opportunities in our
Statistical Programming department.
Summary:
This role will aid in the creation of clinical study reports for regulatory submissions and manuscripts by
programming analysis datasets, tables, figures and listings. They will work collaboratively with Biostatistics, Data
Management, Clinical Science, Clinical Pharmacology, Regulatory, and CRO’s to ensure all project deliverables and
timelines for clinical data reporting are met.
Responsibilities:

Develop, maintain and validate analysis datasets, tables, listings and figures

Develop, maintain and validate local and global macros

Perform exploratory analysis as needed on the project

Establish programming timelines for assigned projects

Oversee CRO programming activities for assigned projects

Represent Statistical Programming team in project team meetings

Review and provide input to the CRF, Statistical Analysis Plan and other study documents.

Develop, maintain and update SDTM and ADAM specifications as needed

Support and mentor junior programmers working on the project
Requirements:

BA/BS in math, statistics, computer science, life science or equivalent and 7 years of experience OR,
MS/MA in math, statistics, computer science, life science or equivalent and 5 years of experience

Oncology experience helpful

Experience working on global regulatory submissions

Thorough understanding and ability in Base SAS

Ability to create and debug SAS macros as needed

Excellent knowledge of SAS/Stat and SAS/Graph

Understands Statistics and is able to interpret study results

Knowledge of CDISC standards, SDTM, ADAM and Tumor Domains

Experience in creating Define.XML package

Experience in executing Open CDISC and FDA recommended validation checks

Knowledge of other languages and tools used for reporting is a plus

Experience in SAS IT support and server administration helpful

Ability to work with others in a cross functional global team environment.
To Apply: Apply online at www.arraybiopharma.com