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Principal Statistical Programmer

Employer
Cytel - EMEA
Location
Various-EU
Salary
Competitive
Start date
22 Mar 2019
Closing date
21 Apr 2019

Job Details

As a principal statistical programmer, job responsibilities may include

serving as a program or study-level programmer in a defined development program supporting the programming and analysis of a clinical study within current or future or across multiple compounds/areas of research,

serving as a lead developer of new technologies, such as innovative visualization techniques or other non-traditional pharmaceutical programming.   Incumbent should have advanced experience for the statistical programming support for the life cycle of a development compound (from phase I/II through phase IV and post approval activities).  Performs as a highly competent and experienced senior level statistical programmer by functioning as a technical resource, internal statistical programming consultant, and mentor to the statistical programming staff.  Works within a Global team.

 Leads and supports statistical programming activities for assigned clinical studies, submissions and development initiatives.  Coordinates and provides input for assigned project and study teams on timelines and work product required to deliver high quality statistical programming services in close collaboration with CROs.

Provides a high level of effective collaboration for statistical programming initiatives with key team members within GSS and groups outside of GSS (Clinical Data Operations, Technology and Standards (CDOTS), Global Medical Writing, New Medicines, Global Clinical Project Management, therapy areas, Marketing & Market Access and Global Clinical Development & Medical Affairs, to facilitate understanding of statistical programming services and work product.  

May program, validate, maintain, and document statistical analysis programs for asset development on the basis of the SAP and of other documents (Protocol, CRF, DMM, ISAP, DAP and ASD) following UCB standard operating procedures and working documents.

Where applicable, develops innovative programming methodologies (i.e. interactive visualization, dashboards, etc.) to facilitate easier interpretation by customer base

Ensures that submission and study datasets (SDTM and ADaM), tables, figures, listings, statistical output, and program documentation meet standards requirements of regulatory agencies and other departments within UCB.

Ensures that datasets, tables, figures, listings, and statistical outputs are produced in an efficient manner, following GSS procedures and standards. Develops specification documentation for datasets (SDTM and ADaM), pooled datasets, tables, figures, listings, and associated metadata.

Supports direction, motivation, and oversight of statistical programming resources (internal and external) for timely delivery of all statistical programming outputs. Mentors and trains other statistical programmers as needed. ? Supports development and rollout of new standards and processes with respect to own statistical programming operations team.

Ensures compliance with the 21-CFR Part 11 regulations in terms of validation of SAS programs used for the purpose of statistical reporting of clinical studies.

Contributes to and manages statistical programming timelines and commitments to timelines for the study and/or project.

Mentors statistical programmers within GSS and develops standards across all programs.

Provides input into and enforces GSS standards.  Enforces GSS SOPs and working practices.  Adheres to the company SOPs and working procedures.

Such other responsibilities and projects that the Company may assign.
Works within a global team and has close interaction with biostatisticians, other statistical programmers, data managers, the Clinical Project Manager (CPM), and the study physician.   
 
Master’s or Bachelor’s degree in statistics, programming, computer science or a related discipline. 


Experience (List the type and length of experience)  Preference will be given to: 5+ (with Master’s degree) to 7+ (with Bachelor’s degree) years in statistical programming within the Biotechnology and/or Pharmaceutical Industry (including clinical research organizations) with proven successful track record in pharmaceutical development.  

Skills:

Excellent written and oral communication skills, including grammatical/technical writing skills, and familiarity with moderately complex statistical methods that apply to Phase I-IV clinical trials are required.

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