Statistical Programmer
Marlborough, MA

Job Description

Sunovion Pharmaceuticals is looking for a Statistical Programmer to join our Data Science team in Marlborough, MA.

Work as a statistical programmer on drug development project teams. Support the inferential analysis of key safety and efficacy endpoints from clinical trials. Primary responsibilities include the production of clinical trial deliverables (e.g. analysis datasets and specifications, well-documented SAS® code, summary tables, figures, listings and analyses) for internal projects in support of internal biostatisticians, as well as providing validation and review of key results for external projects. Develop global macro modules. Must be able to work in a standardized programming environment and communicate results and work product both verbally and in writing.

Essential Functions:

* Support internal biostatisticians in the production of clinical trial report deliverables, including analysis datasets and summary report outputs.
* Provide validation and review services for internal and external projects. Write up and communicate findings, as necessary.
* Write computer programs in SAS for the production of clinical trial deliverables, and document the same, in a manner consistent with internal SOPs.
* Prepare/Review electronic submission deliverables (e.g. Define.XML, Reviewers Guide, XPTs) in a manner consistent with regulatory guidance documents.
* Interact with other project team members, as necessary.
* Interact with external vendor personnel, as necessary.

Minimum Education, Experience, Knowledge and Skills Required:

* Bachelor's or Master's level degree in Biostatistics, Statistics, or a related field.
* 0-3 years of pharmaceutical or biotech industry experience.
* SAS® experience is a requirement.
* Production of clinical study report deliverables, including more than one of the following items: analysis datasets, summary tables, figures and listings.
* Experience with regulatory submission, electronic submissions, and relational databases is desirable.
* The individual in this position should have a demonstrated capability to deliver work product in a multi-project, team-oriented environment.
* SAS® Certification is desirable.
* CDISC training/experience is desirable.
* Experience with electronic submission formats such as eCTD is desirable.

Confidential Data: All information (written, verbal, electronic, etc.) that an employee encounters is considered confidential.

Compliance :Achieve and maintain Compliance with all applicable regulatory, legal and operational rules and procedures, by ensuring that all plans and activities for and on behalf of Sunovion are carried out with the "best" industry practices and the highest ethical standards.

Mental/Physical Requirements: Fast paced environment handling multiple demands. Must be able to exercise appropriate judgment as necessary. Requires a high level of initiative and independence. Excellent written and oral communication skills required. Requires ability to use a personal computer for extended periods of time.