Careers

Key Accountabilities:

Lead Data Management Activities, Perform Training and Client Relationship Management

• Develop and maintain Data Management Project Plan (Plan). Document deviations from the Plan, log and report issues, and follow up on their resolutions.

• Is the primary contact person for day to day data management activities, and is the person ultimately responsible for all data management deliverables for assigned projects.

• Is the primary contact person for communication and discussion of topics related to data management timelines and deliverables; request for out of scope tasks; first line contact for technical or procedural issues.

• Is responsible for planning and implementing data management timelines and deliverables; and is responsible for providing database and data management activities status reports; contributes to the overall project planning, progress tracking and reporting.

• Assist with study-level resource planning and management, including the review of team members’ timesheet reports.

• Assist in performing client relationship management activities. Participate in project bid defense meeting when required.

• Perform training on electronic data capture (EDC) system, dataflow and quality control processes to clinical trial personnel.

• Provide training to new data management personnel on data management processes and procedures. Perform QC review of work performed by less experienced data management personnel.

• Assist in generation of project Work Orders and Amendments.

• Assist in management of dataflow from and performance of Third Party Vendors (Non-CRF data vendors).
• Participate in project kick off meeting, investigators meeting, and regular project management team meeting.
• Provide support to client audits and regulatory inspections. Follow up on audit findings.
• Create and maintain clinical trial Data Management Study Binders.

Perform Hands-on Data Management Activities

• Design and review case report forms (CRFs/eCRFs). Develop and review Case Report Form Completion Instructions. Generate and review annotated Case Report Forms.

• Design and review Clinical Trial Source Document templates and completion instructions when required.

• Develop and maintain data validation specifications.

• Develop and maintain Data Management Plan (DMP). Document deviations from the DMP.

• Participate in the database design process. Participate in EDC User Acceptance Testing (UAT).

• Manage the process of database modifications (after go-live) due to protocol amendments or study needs.

• Develop and maintain Data Quality Review Plan (DQRP). Coordinate with programmers to complete the programming and validation of the listings and summary tables as specified in the DQRP.

• Perform Third Party non-CRF data management activities.

• Review data, issue and resolve queries. Assist Investigative Site personnel with resolving queries.

• Perform Serious Adverse Event reconciliation.

• Assist in resolving medical coding discrepancies resulting from coding of medical history, adverse events, procedures and medicinal products.

• Cooperate and assist the Quality Assurance Department with quality control audits on assigned databases.

• Perform database soft-lock and hard lock activities.
• Maintain and prepare final archival of data management documentation relevant to the assigned clinical trials, and assist the corporate archivist in assembling and archiving such documentation.

Qualifications and Experience:

Key Accountabilities

Sr. SAS Programmer provides hands on support to clinical projects conducted by Supernus Pharmaceuticals for programming clinical trial analysis deliverables with quality and timeliness following established standards and processes. This role is responsible for programming clinical trial analysis deliverables with quality and timeliness, with a hands-on and collaborative approach with other team members. This position requires high degree of independence, technical skills and ability to produce outputs.

Essential Duties & Responsibilities:

• Review and provide input to a Statistical Analysis Plan (SAP)
• Write SDTM and ADaM mapping specifications according to CDISC SDTM Implementation Guide (SDTM IG)
• Write SAS programs to produce and validate SDTM and ADaM datasets
• Produce SDTM define.xml Package including Reviewer's Guide
• Create SAS Annotated Case Report Forms
• Develop SAS utility macros
• Program Tables, Figures, and Listings (TFLs) according to approved specifications
• Prepare analysis datasets to validate vendor provided datasets and prepare ad hoc analyses when needed
• Contribute to standards or process improvements
• Perform other duties as assigned

Non-Essential Duties & Responsibilities:

• N/A

Supervisory Responsibilities:

• N/A

Knowledge and Other Qualifications:

• Minimum Bachelor's Degree and 4+ years or Master’s degree and 2 years’ experience with major in Life Sciences, Computer Science, Mathematics, Statistics or a quantitative/analytical field with pharmaceutical/CRO industry experience
• Minimum 1+ years of hands-on SDTM conversion experience preferred
• Ability to develop SAS programs and macros to create TFL
• Working knowledge of CDISC standards
• Familiarity with ICH guideline and FDA other regulatory authority guidance.
• Excellent written and oral communication skills including grammatical/technical writing skills.
• Excellent attention and accuracy with details.
• Familiarity with statistical methods that apply to Phase I-IV clinical trials.
• Strong organizational skills.
• Ability to solve moderately complex problems (identify, propose & implement solutions).
• Ability to work in team situations.
• Demonstrated strong individual initiative.
• Ability to effectively manage multiple tasks and projects.
• Ability to lead and co-ordinate the work of small teams.
• Ability to work in a fully self-directed manner.