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Clinical SAS Programmer

Company: Softpath System, LLC.
Location: Gaithersburg
Posted on: February 16, 2020

Job Description:

Softpath is a preferred nationwide staffing vendor to Fortune 500 companies in the US and we work directly with our client without any layers as tier 1 vendors. We are out in the market for last 15 years and are also partnered with Companies like INFORMATICA, IBM, COGNOS and ORACLE. Position: Clinical SAS Programmer Location: MD Please adhere to the NOTE from the client about their expectation: Candidates should have experience of Pharma / CROs. We would not able to process their profiles with client as their demand is experienced resource with depth knowledge on Clinical Trials reporting and submission requirements. Essential Qualification : BSc in Mathematical (i.e., Applied Math, Engineering, etc.), Statistical, Computer Science or Life Science 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. Key Responsibilities : Act as the technical leader or subject matter expert for the department, therapeutic area, or drug project in one or more of the following areas: Lead the provision of technical consulting expertise to external partners in relation to the specification and delivery of the SDTM and RDB 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 - Etc. 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 analyzing 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 Job Dimensions: Leadership role, able to lead and direct elements of department, therapeutic area, or project work Accountable for the quality of elements of project programming work worldwide Accountable for good Information Practice on all assigned activities Indirect reporting relationship to the Team Leader (TL)/delegate on assigned drug project teams. Desirable Qualifications : Advanced to expert problem solving and conflict resolution. Advanced to expert verbal and written communication and collaboration skills Drive others to work across global & functional boundaries. Travel willingness and ability to travel domestically and/or internationally. 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. Diligence attention to detail and ability to manage concurrent projects and activities within those projects. Thanks & Regards RACHANA Direct : 678 783 7336 Email: - provided by Dice

Keywords: Softpath System, LLC., Washington DC , Clinical SAS Programmer, Healthcare , Gaithersburg, DC

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