Job Title

• Sr. Statistical Programmer

Position Description

• The purpose of this position is to provide study-level statistical programming suppor
• Executing analysis deliverables to meet the requirements of clinical studies.
• Enforcing standardization of derived datasets and analysis outputs to maximize global data integratability.
• Directing the work of external vendors providing statistical programming services to achieve quality and timely, cost-effective study deliverables.

Position Responsibilities

• Represent the statistical programming function in support of assigned clinical studies
• Define and manage derived data set and reporting standards for common clinical studies using respective company standards.
• Develop, execute, and maintain routine SAS computer programs according to Statistical Analysis Plans (SAPs) or analysis requests to: Produce statistical analysis output (tables, listings and graphs) to support generation of critical (flash) clinical study results or ad-hoc analyses involving descriptive statistics; Perform standard data manipulations, including creation of derived data sets, related to the production of the statistical output; Verify (QC) simple study analysis results or derived data sets produced by another statistical programmer, statistician, or an external vendor.
• For assigned common clinical studies, identify vendor requirements and participate in the evaluation/selection of Analytical Sciences vendors. Provide technical oversight of statistical programming activities of external vendors to assure timeliness and quality of analysis data and statistical outputs. Review and approve key statistical programming vendor deliverables. Seek advice of senior peers, the manager, or the study statistician, if needed, in overseeing the vendor activities and review of outputs.
• 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. Escalate issues to senior peers or management as appropriate and implement solutions.
• Support implementation of programming utilities, data and output standards and improvements to the statistical programming environment.
• Comply with all applicable regulatory requirements,standards and procedures.

Position Requirements

• BS in Statistics, Computer Science, or other related field with minimum 2years SAS programming experience in the pharmaceutical/CRO industry; or MS in Computer Science, Statistics, or other related field with minimum 1 year SAS programming experience in the pharmaceutical/CRO industry.
• Good knowledge of SAS programming language and Base SAS, SAS/GRAPH parts of SAS software, knowledge of simple procedures in SAS/STAT.
• Good understanding of general programming and computing principles, experience with Windows NT and UNIX operating systems, and common software products and technologies used in conjunction with SAS; working knowledge of office software (Microsoft Office).
• Understanding of clinical study documents (protocol, CRF, SAP, Clinical Study Report).
• Understanding of clinical study designs, common analysis methods, descriptive and simple inferential statistics, and data presentation practices.
• Understanding of data management processes, including EDC processes, documents and data flow in clinical trials.
• Basic understanding of drug development process.
• 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.
• Basic project management skills.
• Good oral and written communications skills.

Benefits

• Blue Cross/Blue Shield Medical and Vision
• Delta Dental
• 401K with Company Match
• Holiday and Vacation Pay
• Relocation Assistance

• Clinical Programmer

Delta Pharma is a national leader in the staffing of professionals in the Pharmaceutical, Biotech, and Medical Device industries. Managing the professional staffing needs of leading Pharma companies nationwide, we take pride in bringing Great People and Great Opportunities together.

Come be a part of our success story!

Job Title

·        SAS Programmer (Modeling & Simulation

Position Description

·        As a member of the modeling and simulation (M&S) group in the department of Discovery Medicine and Clinical Pharmacology (DMCP), you will be responsible for the preparation of M&S analysis datasets, assisting in the preparation of M&S reports, performing quality control on analysis datasets and M&S reports, and for the procedures necessary to enable the electronic submission of M&S datasets and reports.. 

Position Responsibilities

• Analysis dataset preparation will require you to interact with members of drug development teams to identify appropriate source data in pharmacokinetic and clinical databases
• Extract and merge this data using SQL and SAS programming to create M&S analysis datasets in SAS transport file format. 
• Assisting in the preparation of M&S reports will include preparation of tables, listings, and plots to be included in the report
• Management of the report review process to ensure that comments are received and addressed in a timely manner.
• You will also be responsible for performing quality control on the analysis datasets and report, and assisting M&S scientists in performing quality

Position Requirements

• Bachelors or Masters Degree in statistics, science or engineering (including computer science).
• Minimum 3-4 years experience in SAS programming related to clinical drug development, as well as SQL, S-PLUS, and NONMEM software.
• Familiarity with principles of quality control and the testing and validation of computer program code.

Benefits

·        Blue Cross/Blue Shield Medical and Vision

·        Delta Dental

·        401K with Company Match

·        Holidayand Vacation Pay

·        Relocation Assistance