What are the responsibilities and job description for the Principal Statistical Programmer position at Lancesoft INC?
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