Principal Programmer

Overview

The Principal Programmer provides communication skills and expertise in the preparation of regulatory, clinical, and marketing documents throughout drug development, post-marketing and life-cycle management. Provides mentoring and support to individual members of the Statistical Programming Team being on the most expert in the field.

Drive and support company projects:

• Data and programming standards
• Enablement and finalization of regulatory submissions, regulatory response documents and other external clinical documents (e.g. publications) across multiple therapeutics area
• In-house database preparation and validation (e.g. Analysis datasets).
• In-house preparation and validation of output (Table, Listing and Figure (TLFs)).
• Pooling strategy for integrated analysis (pooling of data, ISE/ISS TLFs).
• Preparation, review and finalization of regulatory document (e.g. Define.xml, Reviewer’s guide …).
• Deep insight in CDISC standards.
• Provide strong technical programming support to Data Management. Prepare, support and enable corporate clinical meta-data, external clinical dictionaries (e.g. CDISC CT, MedDRA, and WHO DD) and corporate standard reporting systems: SAS macro utility programs and associated tools.

Support clinical studies with programming skills:

• Review study documents (e.g. protocol, CRF, SAP, and Clinical Study Report)
• Take ownership and provide sponsor oversight of outsourced studies to CROs
• Create/review programming documents (e.g. programming plan, specification for datasets and output template)
• Work closely with Biostatistics to assure output quality by providing comments on SAP and output template
• In-house preparation and validation of ad-hoc report output, working closely with the project and/or study statistician.
• Work closely with Data Management to assure data quality by providing ad-hoc QC-analysis.

Be the user representative for the internal Statistical programming data storing and computing environment:

• Provide user needs (Functional Requirements-, User Requirements-, System Design
  - Specification) and change-requests.
• Source Code Handling Applications for Version control
• Define, implement and perform user acceptance test scripts.
• Define and maintain needs and processes

Scope of the Job

• Ensure timely, high-quality deliverables from Statistical Programming in accordance with project milestones and in line with the overall Sobi R&D project portfolio priority
• Responsible for processing of clinical data required for analysis of clinical trials, Phase I-IV.
• Develop SAS coding for preparing, processing and analyzing clinical data.
• Generate and QC summary tables, data listings and graphs for in-house analyses of study data or publications using SAS standard coding practices. Validate work of other programmer/analysts.
• Create/request tools to improve programming efficiency or quality.
• Create/review programming plan, specifications for datasets and TLFs.
• Support data request from other functional group (Biostatistics, Medical Writing, Clinical Development, Drug Safety, Regulatory and Marketing).
• Act as mentor for junior staff by giving lessons, advice and challenging their SAS code

Qualifications:
Qualifications

Education/Learning Experience

Required:

• Bachelor of Science (BSc) in Computer Science, Mathematics, Statistics, pharmaceuticals Sciences, Life Sciences and related areas.

Desired:

• Master of Science (MSc) or PhD

Work Experience

Required:

• A minimum of 10-years experience of Statistical programming in the biotechnology/pharmaceutical industry
• Experience of regulatory submission with FDA or PMDA
• Experience of regulatory submission with EMA
• Excellent written and verbal Communication skills in English

Desired:

• Successful track-record of leading complex projects

Skills/Knowledge

Required:

• Excellent knowledge of SAS programming and associated features and their applications in pharmaceuticals industry environment, in particular clinical trial data setting and clinical submissions (Base SAS, SAS Macro and SAS Graph)
• Familiar with CDISC conventions, i.e. SDTM and ADaM models and related controlled terminologies, and knowledge or some experience using these models
• Familiar with common external coding dictionaries (MedDRA and…