Principal Statistical Programmer, SDTM and ADaM. Sponsor Dedicated

Principal Statistical Programmer, SDTM and ADa M. Sponsor Dedicated

Updated

Location

• London, LND, United Kingdom
• Description
• Principal Statistical Programmer, SDTM and ADa M. Sponsor Dedicated

Syneos Health is a leading fully-integrated life sciences services organization built to accelerate customer success.

We partner with innovators at every point across the drug development and commercialization continuum, helping them navigate complexity, anticipate change and accelerate progress.

Our Clinical Solutions team members act with a drug development mindset, applying their years of experience and deep expertise to truly understand customer needs and represent those in the solutions we shape.

• Job 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.
• Follow 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.

• Conducts effective internal meetings (appropriate in format, frequency and attendance).

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.

Proactively informs management of the status of deliverables and significant project or program issues, including planned resolutions.

• 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 subject matter expert for CDISC and other industry and regulatory requirements, performs compliance reviews of project deliverables for CDISC deliverables including SDTM and ADa M specifications and datasets as well as any regulatory required documents. (i. e.

DEFINE.

• XML)
• When serving as a 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 demonstrated programming experience.
• Extensive programming experience in SAS or other required software, preferably in a clinical trial environment as demonstrated by the ability to lead multiple complex and/or global projects with teams of statistical programmers.
• Knowledge and experience in the use of CDISC Standards for regulatory agency requirements and experience in submissions to a regulatory agency preferred.
• 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.

The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job.

#J-18808-Ljbffr