|
Currently we have the following positions open:
Manager of Clinical Programming in Wayne, PA
Senior Clinical SAS Programmer in Wayne, PA
Biostatistician in Horsham, PA
Sr. Clinical Programmer in Exton, PA
Please call us for more details, salaries, and for consulting rates. Keep in mind we pay referral fees, so if you have colleagues or friends in the business let them know about us! Also remember we are nationwide!
All conversations are completely confidential. Our policy is to never send your information to any of our clients without your prior knowledge and approval.
For more details please contact:
Courtney Allen
Professional Resources, Inc. (PRI)
4 Daniels Farm Rd.
Suite #325
Trumbull, CT 06611
203-225-9900
mailto: callen@pricareers.com
www.pricareers.com
Manager of Clinical Programming
Wayne, PA
Description:
The Manager of Clinical Programming will provide leadership in the creation and validation of SAS programs in support of sponsor's clinical trials; ensuring that the SOPs and guidelines are followed in creating the derived clinical databases and data displays to high quality and per agreed timelines.
The Manager will provide direction to statistical programmers, programmers, and biometricians in creating sponsor deliverables, and will act as lead programmer for regulatory submissions.
Responsibilities:
Report directly to the Director of Clinical Programming
Proactively assess and offer input to the Leadership team regarding programming resource
Overseeing the daily tasks associated with clinical programming and subsequent analysis to ensure sponsor deliverables are created per agreed timelines and to high quality
Adept at managing multiple competing projects including planning, communication, training, and resources
Organize, plan, and prioritize work to develop specific goals across assigned sponsor projects and plans to prioritize, organize, and accomplish individual project objectives including generating and maintain key milestone reports
Recognizes scope changes. Quantify and assess the impact of scope changes on cost and schedule. Relays change order effectively to Clinical Project Manager.
Prepares staffing needs and updates management on a weekly basis.
Work with other team members to ensure sponsor deliverables are correct and complete
Communicate and collaborate effectively with cross functional teams including but not limited to DIS, Statistics, Data Management, and Project management to ensure smooth execution of projects
Monitor projects to ensure that SOPs are properly followed and documentation is completed
Ensure project specifications and documentation are correct and complete
Lead by example, act as lead programmer in some capacity on assigned projects
Assist in the candidate search (resume review) and interviewing process.
Contributes towards annual review process.
Mentor and train others in programming and program coding
Training programmers and others on programming best practices, processes, procedures, regulations, and guidances
Lead group initiatives as assigned. These may include but are not limited to SOP revision or development, technology recommendations and implementation, process improvement, and macro development
Experience:
Bachelors Degree or Masters Degree in a related discipline or related experience.
Minimum 7 + years of experience in a pharmaceutical or clinical research setting as senior SAS or statistical programmer.
Minimum 2 + years of management experience required, previous project leader or lead programmer experience will also be considered.
Extensive knowledge of SAS programming, SDTM, ADaM, FDA, and ICH guidance.
Communicate and collaborate effectively with cross-functional teams in face-to-face conversation, by telephone, and by email.
Senior Clinical SAS Programmer
Wayne, PA
Description:
The Senior Clinical SAS Programmer creates SAS programs in support of sponsor's clinical trials according to SOPs and guidelines. This programmer will create, document, validate, process, and maintain statistical programs and macros that generate analysis datasets, tables and graphics with high quality per agreed timelines. As a project lead the Senior Clinical SAS Programmer will provide direction and oversight to programmers in creating sponsor deliverables.
Responsibilities:
Act as lead programmer to write SAS programs that produce analysis datasets and analyses specified in the Statistical Analysis Plan
Act as quality control programmer to validate SAS programs that produce analysis datasets and analyses specified in the Statistical Analysis Plan
Assist the Manager of Clinical programming in overseeing the daily tasks associated with clinical programming and subsequent analysis to ensure sponsor deliverables are created per agreed timelines and to high quality standards.
Ensure SAS programs adhere to SOPs, guidelines, and specifications
Ensure SAS program output matches the requirements of the Statistical Analysis Plan
Consult with managerial, statistical, data management, DIS, and medical writing personnel to clarify program intent, identify problems, and suggest changes.
Design and/or review database structure
Create derived-analysis datasets
Execute analyses specified in the Statistical Analysis Plan (SAP) or Report and Analysis Plan (RAP) under the guidance of the project statistician
Take instructions and perform tasks as necessary as directed by reporting manager
Ensure specifications and documentation are correct and complete
Work with other team members to ensure outputs are correct and complete
Mentor others in programming and program coding
Organize, plan, and prioritize work to develop specific goals and plans to prioritize, organize, and accomplish project objectives
Analyze information and evaluate results to choose the best solution and solve problems.
Perform programming in support of sponsor ad hoc requests
Produce special reports to comply with regulatory requests
May interact directly with sponsors to facilitate project completion
Experience:
Minimum 6 years SAS programming experience in the pharmaceutical, biotechnology, and/or contract research organization industries.
Extensive knowledge of Base SAS, SAS/GRAPH, SAS/STAT, and ODS
Experience working with heterogeneous data structures
Ability to work independently and adept at managing multiple competing tasks
Good understanding of clinical data and pharmaceutical development
Knowledge of SDTM, ADaM, FDA and ICH guidance
Knowledge of clinical trial conduct and the data and reporting requirements for clinical trials
Knowledge of SAS programming techniques needed to produce outputs in accordance with specifications
Communicate and collaborate effectively with cross-functional teams in face-to-face conversation, by telephone, and by email
|
