Principal Statistical Programmer

**Title**:
Principal Statistical Programmer

**Company**:
Ipsen Innovation (SAS)

Under the supervision of the Executive Director, Statistical Programming, the Principal Statistical Programmer will participate in the creation, maintenance and finalization of clinical study datasets for Clementia’s / Ipsen development programs. The Principal Statistical Programmer will ensure that all clinical datasets 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 clinical trial 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.

EHS Mission/Duties

Participate in the EHS training as proposed or requested on the site

Contribute to reduce the environmental impact of the activities on the site

Inform his / her superiors of any changes affecting the workstation, in order to improve the EHS on site.

Experience / Qualifications

Relevant experience of pharmaceutical drug development:
Bachelor’s degree or higher in Statistics, Mathematics, or Scientific Discipline.

At least 8 years of biopharmaceutical experience as a Statistical Programmer.

Solid knowledge of SAS programming language.

Knowledge of regulatory requirements (FDA, ICH).

Experience in working with multidisciplinary groups (internal & external), flexibility, adaptability and ability skills to work within a matrix environment.

Qualifications:
Experience in organizing NDA/s NDA regulatory submissions.

Understanding of clinical trial design and reporting process, as well as regulatory reporting requirements including electronic data submissions and CDISC implementation.

Ability to execute and manage multiple simultaneous projects and deadlines with shifting priorities and resources in a fast-paced working environment.

Excellent leadership skills and capability to work within a team as leader and team player,

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

Good computer literacy

Joint problem solving. Engages internal and external stakeholders proactively to find innovative and feasible solutions.

Conflict resolution. Identifies conflicts in a timely manner, facilitates joint discussion to enable stakeholders to share their thinking constructively, manage group emotions and operationalize the conflict management process.

Flexibility. Adapts quickly to changing environments and remains open to learning. Understands team dynamics, differences and working styles and adapts according to a preferred team style based on the situation. Drives results in ambiguous situations.

The statements contained herein reflect general details as necessary to describe the principles functions for this job, the level of knowledge and skill typically required, and the scope of responsibility, but should not be considered an all-inclusive listing of work requirements. Individuals may perform other duties as assigned, including work in other functional areas to cover absences or relief, to equalize peak work periods or otherwise balance workload.

This description is not intended to be constructed as an exhaustive list of duties, responsibilities, or requirements for the position. This position may change or assume additional duties at any time. The employee may be requested to perform different or additional duties as assigned. All Employees are expected to adhere to all company policies and act as a role model for company values.