Lead Statistical Programmer – SAS, CDISC, Remote

Chiesi Farmaceutici S.p.A.; Parma; Hybrid; EUR 41,400 - 50,600; Full time

Benefits offered by this job

Annual bonus

Relocation support

Private medical insurance

Job summary

Chiesi Farmaceutici S.p.A. in Parma, Italy, is seeking a Lead Statistical Programmer to drive SAS programming across clinical and safety data systems and prepare data packages for regulatory submission. You will lead project deliverables, ensure data quality and regulatory compliance.

The role requires extensive SAS expertise, CDISC knowledge, and experience with data management and reporting. You will mentor team members, develop standard programs, and collaborate with CROs to deliver on time

Qualifications

• Bachelor’s Degree in a related field required (Health Sciences, Statistics, Computer Science).
• 7 years of Pharmaceutical/CRO experience.
• High level of SAS experience and expertise.
• Solid understanding of Data Management and Biostatistics processes.
• Experience cleaning and resolving data issues and merging data from different sources.
• Experience creating and maintaining a SAS reporting system to generate listings, tables and flexible data outputs.
• In depth understanding of CDISC standards.
• Demonstrates effective organizational and time-management skills.
• Ability to manage multiple priorities independently.
• SAS certification and/or A. Stat or P. Stat accreditation are definite assets.

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.
• 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.
• 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.
• 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.
• Participates in the development of SOP and Work Instructions for SAS related programming activities. Ensures compliance to these SOPs.
• 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.

Skills

SAS programming

SAS data management

Regulatory data submission

CDISC standards

Project leadership

Education

Bachelor’s degree in Health Sciences/Statistics/Computer Science

Master’s degree preferred

Job description

Chiesi Farmaceutici S.p.A. in Parma, Italy, is seeking a Lead Statistical Programmer to drive SAS programming across clinical and safety data systems and prepare data packages for regulatory submission. You will lead project deliverables, ensure data quality and regulatory compliance.

The role requires extensive SAS expertise, CDISC knowledge, and experience with data management and reporting. You will mentor team members, develop standard programs, and collaborate with CROs to deliver on time