Statistical Programmer

Purpose

Functions as a Lead Statistical Programmer, participates in SAS related programming activities for all clinical and safety data systems at Chiesi as well as activities in preparing data and metadata packages for regulatory submission. 
The Principal Statistical Programmer is responsible for project-specific internal and external deliverables regarding SAS programming to be completed within budget and on time. 

Main Responsibilities

•    Establishes the SAS programming needs for a project and develops work-plan to deliver SAS outputs to meet project deliverables.
•    Responsible for the production of quality data outputs and preserving data integrity.
•    Participates in the writing, validation and maintenance of SAS programs to generate SAS datasets, spreadsheets, data listings, tables and graphical displays of clinical trial, safety and post marketing data residing in all data systems owned by Chiesi GRD.
•    Builds and maintains a library of SAS programs and develops surrounding processes. 
•    Performs and documents validation (quality control checks) of various outputs and programs to support Chiesi’s deliverables.
•    Supports in providing expertise regarding data collection, set up and the impact on the data and metadata packages. Provides feedback to ensure the data is collected in a standardized manner and annotated as per standards required for submission. 
•    Contributes to the Statistical Analysis Plan via the review of the SAP and coordination of the production of mock-up table shells and TLFs.
•    Builds a library of standard edit checks in SAS to supplement edit checks in data systems owned by DM, Chiesi or in datasets received via CROs, looking for trends that could indicate problems with protocol adherence or data issues.  
•    Develops Case Report Tabulations (datasets, transport files) and associated metadata documentation for submissions using advanced knowledge of CDISC standards. Creates/adjusts processes as needed to ensure compliance with data submission standards.
•    Provides technical expertise as needed for all programming issues. 
•    Participates in defining new SAS programming requirements for new, complex projects based on protocol and disease under study.
•    Utilizes advanced problem-solving techniques in the assessment, development and implementation of best practices for SAS, data management and reporting.
•    Demonstrates ability to make sound decisions on complex issues related to daily activities and refers contentious issues with recommendations to the next level (e.g. issues that arise from discrepancy management process).
•    Demonstrates leadership in creation and promotion of an environment of teamwork, clearly communicating the expectations and objectives of the project.
•    Shows initiative in keeping self at the “leading-edge” of their field
•    Performs all work in accordance with established regulatory requirements ensuring compliance with GCP, GCDMP and CFR 21.11 guidelines.  Maintains and further develops and in-depth knowledge of these documents.
•    Participates in the development of SOP and Work Instructions for SAS related programming activities. Ensures compliance to these SOPs.
•    Responsible to ensure compliance of team members (direct reports) with Safety and Employment policies (e.g., Respect in the Workplace - Prevention of Violence and/or Harassment).
•    Works as a member of a team to achieve all outcomes.
•    Performs all work in accordance with all established regulatory and compliance and safety requirements.
•    Fulfil a leading role in set-up and maintenance of data warehouse activities
•    Initiate and develop novel tools to support the decision making progress.
•    Leads any submission related programming activities
•    Oversees any programming activities as performed by a CRO

Experience Required

>7 years of Pharmaceutical/CRO experience required

Education

Bachelor’s Degree in a related field required (e.g. Health Sciences, Statistics, Computer Science). Master’s preferred.

Languages

English fluent

Technical Skills

High level of SAS experience and expertise as demonstrated in previous work
A solid understanding of the Data Management and Biostatistics processes.
Experience cleaning and resolving data issues as well as merging data from different sources into a single integrated dataset.
Experience in creating and maintaining a SAS reporting system to generate listings, tables and flexible data outputs.
In depth understanding of CDISC standards is required.
Strong interpersonal and verbal/written communication skills.
Demonstrates effective organizational and time-management skills. Ability to manage multiple priorities in an efficient manner.
Demonstrates ability to work independently and as part of a team.
SAS certification and/or A. Stat or P. Stat accreditation are definite assets.

Soft Skills