Sr & Pr Statistical Programmer

About the role

This position functions as a member of the Biostatistics and Statistical Programming project team serving as a lead statistical programmer or reviewer for any project, especially those of high complexity and scope, or integrated summaries of safety/efficacy for submission, in the development of programs to support the conduct, statistical analysis and reporting of projects; creates, tests, and maintains programs for clinical studies, coordinating the efforts of other programming personnel; determines the overall strategy for the programming tasks on a project or across a program or submission; manages project budgets and tracks project specific performance metrics; functions as an internal and external customer liaison; provides input to statistical analysis plans; leads the creation and maintenance of statistical programming project documentation and regulatory submission packages.

Responsibilities

• Uses SAS, or other software, to develop custom programming code to generate summary tables, data listings, graphs and derived datasets as specified in the statistical analysis plan and programming specifications.
• Works to ensure that outputs meet quality standards and project requirements.
• Performs validation programming and works with other programmers, biostatisticians, and other project team members to resolve discrepancies or any findings.
• Keeps project team members informed of programming progress and issues requiring their attention.
• Follows applicable SOPs, WIs, and relevant regulatory guidelines (e.g. ICH).
• Maintains well organized, complete, and up-to-date project documentation, testing, and verification/quality control documents and programs ensuring inspection readiness.
• Manages scheduling and time constraints across multiple projects at a time, sets goals based on priorities from management, and adapts to timeline or priority changes by reorganizing daily workload.
• Develops specifications for datasets and outputs of any complexity according to statistical or sponsor requirements.
• Anticipates and addresses potential programming issues, reflects forethought, establishes the basis for efficient programming and accurately defines all variables to be accepted by peer review and sponsor/requestor with little rework.
• Distributes relevant information in advance. Ensures minutes are promptly and accurately distributed. Follows action items through to completion, and maintains order and focus of meetings, working toward consensus.
• Displays willingness to work with others and assist with projects and initiatives as necessary to meet the needs of the business.
• Accountable for on-time delivery across concurrent programming deliverables.
• Negotiates programming timelines and provides risk mitigation plans for projects or programs, as needed.
• Acts as the lead statistical programmer.
• Directs the programming activities of other programming personnel and monitors progress on programming deliverables.
• Reviews project documentation such as Statistical Analysis Plan, mock shells, programming specifications, annotated CRFs, and SAS database design. Provides feedback to the appropriate project team members which reflects forethought and reduces inefficiencies in programming activities.
• Participates in sponsor meetings, kickoff meetings, and bid defense meetings as statistical programming representative, as required by sponsor.
• Contributes to the mentoring of programming personnel through developing training courses, presenting training materials, reviewing work, and providing feedback or guiding new associates in process.
• Maintains a good working knowledge of clinical drug development, industry standards, and electronic submission requirements; serves as a technical expert resource to other department members for complex programming questions.
• Works cooperatively with other biostatistics and statistical programming personnel to establish standard operation procedures (SOPs), guidelines, policies, and/or procedures. Contributes technical expertise to the development of programming tools and macros for standardization and efficiency.
• When serving as a technical subject matter expert for CDISC and other industry and regulatory requirements, provides guidance and training to the Biostatistics group and other departments on the appropriate use of CDISC Standards.
• When serving as a technical subject matter expert for CDISC and other industry and regulatory requirements, performs compliance reviews of project deliverables for CDISC deliverables including SDTM and ADaM specifications and datasets as well as any regulatory required documents. (i.e. DEFINE.XML)
• When serving as a technical subject matter expert for CDISC and other industry and regulatory requirements, actively participates in industry standards organizations and provides regular updates to the Biometrics Department on upcoming changes to those standards.
• Transfers deliverables.
• Performs other work-related duties as assigned.

Qualifications

• Undergraduate degree, preferably in a scientific or statistical discipline; in lieu of degree, an equivalent combination of education and 8+ years of experience in Clinical SAS programming.
• Extensive programming experience in SAS, ADAM, TLF, SDTM or other required software in a clinical trial environment as demonstrated by the ability to lead multiple complex and/or global projects with teams of statistical programmers.
• Experience in submissions to a regulatory agency is required.
• Experience in mentoring others in clinical trial process and CDISC Standards.
• Excellent written and verbal communication skills.
• Ability to read, write, speak and understand English.

Job Overview

The Clinical Data Manager III is responsible to participate the clinical data management activities for a project within a data management team; including processing of Case Report form and electronic data, processing and reconciliation of external data, SAE reconciliation and supporting the database close/lock procedures in accordance with Caidya SOPs, Good Clinical Practice, ICH Guidelines and sponsor requirements. Work as a Project Point of Contact (POC), manage work allocation and work with minimal or no supervision.

Job Duties And Responsibilities

• For specified projects performs start-up activities including:
  • Developing data management guidelines and study documentation
  • Review of CRF design against protocol
  • Lead study developing core study documents for data management including DMP, DVP, CRF completion guidelines, and other study documentation. Activities include design, database structure, document creation; including approval
• For specified projects performs data management activities as detailed below and performs activities in accordance with our SOPs, Good Clinical Practice, ICH Guidelines and study documentation.
  • Study status tracking
  • Review of data listings
  • Identification of data issues and query generation
  • Updating of database with query resolutions (paper studies only)
  • Processing and reconciliation of external data including SAE reconciliation
  • Ownership and proactive management of the data reconciliation activities documented in the DVP, DMP, etc.
  • Provide input for Database closeout and lock activities and timelines
  • Archiving of critical documents on an ongoing basis
• If assigned the Lead Data Manager role, act as key data management contact for the project.
  • Awareness of the CAPA process and provide input for audit responses regarding assigned tasks
  • Proactive management of project quality through supervision and quality control of team members’ work
  • Proactive participation in appropriate sponsor/project team meetings
  • Active involvement in departmental and organizational meetings and initiatives
  • Develops and documents departmental procedures
  • Training and Mentoring of team members in accordance with established departmental procedures
  • Supports and tracks budget adherence in cooperation with Finance to ensure the assigned studies are meeting targeted margins and utilization
  • Continuous improvement of departmental processes and procedures to ensure DM is consistently maximizing efficiencies, leveraging technology and incorporating innovation to optimize delivery
  • Maintains working knowledge of regulatory requirements/guidance as well as industry leading best practices to ensure Caidya DM procedures are in line with industry expectations.
• Indirect supervision of the work of junior members of the project team.
• Other duties as assigned.
• Supervisory Responsibilities - No supervisory responsibilities.