Priya Mukherjee at CK Clinical is currently recruiting for a Statistical Programmer to work for a leading pharmaceutical organisation in central London.
As a Statistical Programmer you will be involved in:
- Designing and creating analysis deliverables to meet the requirements of clinical studies.
- Managing and enforcing standards for derived datasets and analysis outputs to maximize global data integration
- Directing the work of external vendors providing statistical programming services to achieve quality and timely, cost-effective study deliverables.
As a Statistical Programmer you will have the following responsibilities:
- Represent the statistical programming function in support of assigned clinical studies and projects in both the US and EU.
- Define and manage the structure and contents of derived data set and reporting outputs following Global standards.
- Independently develop, execute, and maintain SASÒ computer programs, including macro programs, according to Statistical Analysis Plans (SAPs), cross-study analysis and data specifications, or analysis requests to: Produce statistical analysis output (tables, listings and graphs) involving descriptive and inferential statistics to support creation of the clinical study report cross-study results for investigator brochures and regulatory submissions, and/or ad-hoc and exploratory analyses.
- Perform data manipulations, including creation of derived data sets, related to the production of the statistical output.
- Verify /QC study and cross-study analysis results or derived data sets produced by another statistical programmer, statistician, or an external vendor
- Identify vendor requirements and participate in the evaluation/selection of BDM vendors.
- Provide technical oversight of statistical programming activities to external vendors to ensure timeliness and quality of analysis data and statistical outputs.
- Review and approve key statistical programming vendor deliverables.
- Define and manage transfers of all externally produced analysis data and outputs.
- Archive statistical outputs and related documentation according to company standards.
- Anticipate and communicate resource and quality issues that may impact deliverables or timelines.
- Propose and implement solutions
- Escalate issues to management as appropriate
- Contribute to increasing efficiency of the Statistical Programming function through development of programming utilities, data and output standards, and improvements to the statistical computing environment
- Support implementation of such utilities, standards and process improvements
- Comply with all applicable regulatory requirements and company standards and procedures.
Qualifications and skills:
The successful candidate for this Statistical Programmer role must have the following skills and qualifications:
- MS in Statistics, Computer Science, or other related field with proven experience of SAS programming in the pharmaceutical/CRO industry.
- Hold advanced knowledge of SAS programming language and Base SAS, SAS/GRAPH parts of SAS software, good knowledge of common procedures in SAS/STAT. Good knowledge of general programming and computing principles, experience with Windows and UNIX operating systems, and common software products and technologies used in conjunction with SAS, expertise in office software (Microsoft Office).
- Good knowledge of clinical study documents (protocol, CRF, SAP, Clinical Study Report).
- Working knowledge of clinical study designs, common analysis methods, descriptive and simple inferential statistics, and data presentation practices. Good knowledge of data management processes, including EDC processes, documents and data flow in clinical trials.
- Basic knowledge of drug development process.
- Good knowledge of FDA and ICH regulations and industry standards applicable to clinical study data and reporting on clinical trials, including data standards for electronic submissions.
- General project management skills
- Good oral and written communications skills
How to apply:
Fore more information or to apply for this Statistical Programmer role please contact Priya Mukherjee on firstname.lastname@example.org or 01438 744 047. Please quote reference CL24539 in all correspondence.