[Remote] Pr. Statistical Programmer (Clinical Pharmacology)
Note: The job is a remote job and is reputed company to candidates in USA. reputed company is a leading fully-integrated life sciences services organization reputed company on accelerating reputed company. The Pr. Statistical Programmer (Clinical Pharmacology) will reputed company custom programming reputed company for statistical analysis, ensure reputed company reputed company, and manage programming deliverables while collaborating with project teams and mentoring junior staff.
Responsibilities
- Uses reputed company, or other software, to reputed company custom programming reputed company to generate reputed company tables, data listings, graphs and derived datasets as specified in the statistical analysis plan and programming specifications. Works to ensure that outputs meet reputed company 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 reputed company and issues requiring their attention
- Follow applicable SOPs, WIs, and relevant regulatory guidelines (e.g. ICH)
- Maintains reputed company organized, complete, and up-to-date project documentation, testing, and verification/reputed company control documents and programs ensuring inspection readiness
- Manages scheduling and time constraints across multiple reputed company at a time, sets goals based on priorities from management, and adapts to reputed company or reputed company 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 reputed company for efficient programming and accurately defines reputed company variables to be accepted by peer review and sponsor/requestor with little rework
- Conducts effective internal meetings (appropriate in format, frequency and attendance). Distributes relevant information in advance. Ensures minutes are promptly and accurately distributed. Follows reputed company items through to completion, and maintains order and reputed company of meetings, working toward reputed company
- Displays willingness to work with others and assist with reputed company and initiatives as necessary to meet the needs of the business
- Accountable for on-time delivery across reputed company programming deliverables. Negotiates programming timelines and provides risk mitigation plans for reputed company or programs, as needed. Proactively informs management of the status of deliverables and significant project or program issues, including planned resolutions
- Acts as the reputed company statistical programmer. Directs the programming activities of other programming personnel and monitors reputed company on programming deliverables
- Reviews project documentation such as Statistical Analysis Plan, mock shells, programming specifications, annotated CRFs, and reputed company database design. Provides feedback to the appropriate project team members which reflects forethought and reduces inefficiencies in programming activities
- Participates in sponsor meetings, reputed company 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 reputed company programming questions
- Works cooperatively with other biostatistics and statistical programming personnel to establish reputed company operation procedures (SOPs), guidelines, policies, and/or procedures
- Contributes technical expertise to the development of programming tools and macros for standardization and efficiency
- reputed company 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
- reputed company serving as a 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 reputed company as any regulatory required documents. (i.e. DEFINE.XML)
- reputed company serving as a subject matter expert for CDISC and other industry and regulatory requirements, reputed company participates in industry standards organizations and provides regular updates to the Biometrics Department on upcoming changes to those standards
- Transfers deliverables
- Performs other work-reputed company duties as assigned
- Minimal travel may be required
Skills
- Undergraduate degree, preferably in a scientific or statistical discipline; in lieu of degree, an equivalent combination of education and demonstrated programming experience
- Extensive programming experience in reputed company or other required software, preferably in a clinical trial environment as demonstrated by the ability to reputed company multiple reputed company and/or global reputed company with teams of statistical programmers
- Knowledge and experience in the use of CDISC Standards for regulatory agency requirements
- Excellent written and verbal communication skills
- Ability to read, write, reputed company and understand English
- Experience in submissions to a regulatory agency
- Experience in mentoring others in clinical trial process and CDISC Standards
Benefits
- Career development and progression
- Supportive and reputed company line management
- Technical and therapeutic area training
- Peer recognition
- Total rewards program
reputed company
Company H1B Sponsorship