Associate Director Statistical Programming

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 standardsEnablement and finalisation of regulatory submissions, regulatory response documents and other external clinical documents (e.g. publications) across multiple therapeutics areaIn-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 CROsCreate/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 templateIn-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 controlDefine, implement and perform user acceptance test scripts.Define and maintain needs and processesEnsure timely, high-quality deliverables from Statistical Programming in accordance with project milestones and in line with the overall Sobi R&D project portfolio priorityResponsible for processing of clinical data required for analysis of clinical trials, Phase I-IV.Develop SAS coding for preparing, processing and analysing 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