Principal Statistical Programmer
Proclinical has partnered with a global pharmaceutical organisation in search for a Principal SAS Programmer in England. You will be given the opportunity to oversee and deliver programmes for clinical development, internal decision making and regulatory submissions. If you're ready to step into this role and establish your career then this is the role for you.
- Lead the provision of technical consulting expertise to external partners in relation to the specification and delivery of the SDTM and ADaM databases by these partners.
- The creation of regulatory deliverables including but not limited to:
- Regulatory response to agency queries
- Development Safety Update Reports (DSUR)
- Periodic Benefit-Risk Evaluation Report (PBRER)
- Investigators brochures (IB)
- Data submission strategy, i.e., legacy data, pooling data, communications with regulatory agencies
- Therapeutic area specific analyses
- Outcomes studies/outcomes management
- Payer research/reimbursement
- Standards, e.g., CDISC, Astra Zeneca, governance MDR principles
- Data preparation and analysis for Global Medical Affairs work
- Pharmacokinetics/pharmacodynamics data preparation and analysis
- Manipulating and analysing adjudicated data
- Planning and executing the transfer and analysis of data for data safety monitoring boards/independent data monitoring committees
- Planning and delivering Clinical Trial Transparency (data de-identification)
- Work with the Statisticians to create the randomization schedules for the clinical trials
- Other areas as assigned
Skills and Requirements
- BSc in Mathematical (i.e., Applied Math, Engineering, etc.), Statistical, Computer Science or Life Science
- Extensive SAS programming expertise to an advanced level
- Comprehensive knowledge of technical and regulatory requirements related to the role
- Knowledge of CDSIC standards and industry best practices
- Subject matter expert in one or more areas of programming within clinical drug development.
- Excellent verbal and written communication skills
- Assist in developing and delivering training in areas of expertise
- Advanced to expert verbal and written communication and collaboration skills.
- Advanced to expert problem solving and conflict resolution.
- Ability to apply programming knowledge and skills to problems, problem solving, and quality focus. Troubleshoots for team.
- Contributes to defining business processes and accurately completes and manages associated documentation.
- Team commitment: prioritise attendance at appropriate project team meetings; take steps to understand and appreciate the roles, skills and strengths of others on the team.
ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.