Principal Statistical Programmer

Under the supervision of the Head of Statistical Programming, the Contractor Statistical Programmer will be assigned to work on a TA/Study at Ipsen.  The contractor will participate in the oversight, creation, maintenance and finalization of clinical study datasets/TFL for Ipsen development programs, and ensure all clinical datasets perform the analysis defined by SAP and meet the standards required for regulatory submissions for all INDs and NDAs/MAAs Main responsibilities / job expectations

• Responsible for Statistical Programming activities, including analyzing, integrating and reporting of clinicaltrial data in order to produce quality and timely deliverables.
• Performs data analysis using primarily the SAS programming language for the summary and interpretation of clinical trial data.
• Provide statistical programming support to generate derived analysis data sets, tables, listings, and figures for Clinical Study Reports, regulatory submissions, annual IND safety update reports and Integrated summaries (ISS/ISE).
• Creation/QC of CDISC SDTM and ADaM files, SAS export files and Define.xml use for Electronic Submission from the data received in non-standard form from various sources.
• Interact with Statisticians, Programmers and other members of the clinical team, perform ad hoc analysis and generate outputs according to the requirements.
• Review and comment on CRFs, annotated CRFs, Data Management Plan, Data validation plan, edit check specifications and study related documents.
• Participate in operations meetings and address issues that may influence statistical programming and data management.
• Work with CRO statisticians, statistical programmers and review/QC their work/deliveries.

    Knowledge, abilities & experience Education / Certifications:

• Bachlor’s degree or higher in Statistics, Mathematics, or Scientific Discipline

Experience:

• 5 years’ programming experience in pharmaceutical/biotech/CRO environment in drug discovery/clinical trials / drug development
• Experience in working with multidisciplinary groups (internal & external), flexibility, adaptability and ability skills to work within a matrix environment.

Languages:

• Strong verbal and written communication skills (English) with the ability to communicate effectively at different levels of the organization

Key Technical Competencies Required

• Proficiency in statistical programming package(s), SAS is required; R or other packages are desired.
• Familiar with Global Clinical Data Interchange Standards Consortium (CDISC).
• Understand clinical data flow.  Experience in NDA submission is desired.
• Experience in SDTM and/or ADaM specification and programming.
• Experience in TFL programming.
• Ability to execute and manage multiple simultaneous projects and deadlines with shifting priorities and resources in a fast-paced working environment.
• Good computer literacy