Principal Statistical (SAS) Programmer - Cdisc - Raw Data Sets

Location Cambridge

Job Description The Principal Statistical Programmer will be responsible for providing expert-level hands-on support and technical leadership to clinical project teams.

This individual will lead and provide hands-on support to the design, development, and quality control process for SAS code used to access, extract, transform, review, analyze, and submit data for multiple studies and clinical development programs.
Within a matrix framework, they will manage tasks performed by teams of Statistical Programmers and represent them at clinical project team meetings. They will assure that team deliverables met timeline, budget, and quality expectations.
They will lead process and technology improvement working groups within the department and be our representative on cross functional initiatives.

Key Responsibilities:
Provide project management for Statistical Programming teams on multiple studies including leadership, communication, timeline and resource planning, organization, delegation, coordination, metrics, and mentoring.
Effectively design and code SAS applications for multiple clinical projects, consistently meeting objectives of the clinical development program.
Provide Statistical Programming teams with technical solutions and organizational support to solve highly complex problems within budget and time line constraints, while assuring high quality standards.
* Give expert level support and guidance to create easily maintained SAS code to solve complex problems in the analysis and reporting clinical trial data and for the review, exchange, transformation, and submission of data in CDISC SDTM and ADaM formats.
Apply expert level subject matter expertise in regulatory requirements, software validation and system development life cycle concepts, medical data, design and phases of clinical trials, statistics, and the pharmaceutical industry to all tasks. Actively supports transfer of this knowledge to other staff.
Manage Statistical Programming timelines and activities for projects outsourced to CROs. Contribute to the design and review vendor proposals and contracts. Actively manage outsourced activities to assure they met timeline, budget, and quality expectations.
* Perform quality control of SAS code and output produced by internal staff and CROs.
Lead and develop processes and global tools that increase the efficiency and capacity of the Statistical Programming group. Represent the department on cross functional improvement initiatives.
Conduct briefings and participates in technical meetings for internal and external representatives (e.g., IS, CROs, Clinical Development Partners, Software Vendors, FDA, EMEA) on assigned projects.
Make internal and external presentations on topics related to Statistical Programming and clinical studies.
Perform tasks with minimal instruction from supervisor.
Direct supervision of contract staff may be required.

Minimum Qualifications Minimum Requirements:

B.S. in Biostatistics, Statistics or Computer Science

7 years of experience w/SAS in the pharmaceutical industry
Preferred Qualifications:

Masters Degree or PhD in Biostatistics, Statistics or Computer Science
8+ years of experience w/SAS in the pharmaceutical industry

To find out more about Real Staffing please visit www.realstaffing.com