R/SAS Statistical Programmer (hiring in Armenia, Hungary, Estonia, CR, Romania, Argentina, Braz[...] in London

MUST BE LOCATED IN ONE OF THE FOLLOWING LOCATIONS WITH NO SPONSORSHIP NEEDS: Armenia, Hungary, Estonia, CR, Romania, Argentina, South Africa, Brazil, or Columbia.

R Programming experience required.

CDISC - SDTM/ADAM programming experience required.

Use R and SAS 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; ensure outputs meet quality standards and project requirements.

Perform validation programming and work with other programmers, biostatisticians, and project team members to resolve discrepancies or findings; keep project team members informed of programming progress and issues requiring attention.

Follow applicable SOPs, WIs, and relevant regulatory guidelines (e.g. ICH).

Maintain well organized, complete, and up-to-date project documentation, testing, and verification/quality control documents and programs ensuring inspection readiness.

Manage scheduling and time constraints across multiple projects, set goals based on priorities, and adapt to timeline or priority changes by reorganizing daily workload.

Develop specifications for datasets and outputs of any complexity according to statistical or sponsor requirements; anticipate and address potential programming issues, reflect forethought, establish the basis for efficient programming and accurately define all variables to be accepted by peer review and sponsor/requestor with little rework.

Conduct effective internal meetings (appropriate in format, frequency and attendance); distribute relevant information in advance; ensure minutes are promptly and accurately distributed; follow action items through to completion; maintain order and focus of meetings, working toward consensus.

Display 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; negotiate programming timelines and provide risk mitigation plans for projects or programs; proactively inform management of the status of deliverables and significant project or program issues, including planned resolutions.

Act as the lead statistical programmer; direct programming activities of other programming personnel and monitor progress on programming deliverables.

Review project documentation such as Statistical Analysis Plan, mock shells, programming specifications, annotated CRFs, and SAS database design; provide feedback to the appropriate project team members which reflects forethought and reduces inefficiencies in programming activities.

Participate in sponsor meetings, kickoff meetings, and bid defense meetings as statistical programming representative, as required by sponsor.

Contribute to the mentoring of programming personnel through developing training courses, presenting training materials, reviewing work, and providing feedback or guiding new associates in process.

Maintain a good working knowledge of clinical drug development, industry standards, and electronic submission requirements; serve as a technical expert resource to other department members for complex programming questions.

Work cooperatively with other biostatistics and statistical programming personnel to establish standard operation procedures (SOPs), guidelines, policies, and/or procedures.

Contribute 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, provide guidance and training to the Biostatistics group and other departments on appropriate use of CDISC Standards.

Perform compliance reviews of project deliverables for CDISC deliverables including SDTM and ADaM specifications and datasets as well as any regulatory required documents.

Actively participate in industry standards organizations and provide regular updates to the Biometrics Department on upcoming changes to those standards.

Transfer deliverables.

Perform other work-related duties as assigned.

Minimal travel may be required.

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 R or other required software, preferably in a clinical trial environment; 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; 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.

Summary:

Strong ADAM safety and efficacy experience with SAS and R is required. DMC experience would be nice to have. 5-8 years of experience is ideal. Roles within the Statistical Programming job family are responsible for developing programs and providing statistical programming support for statisticians or for client or business use to address needs for sourcing, organizing (creating statistical tables, listings, and graphs), and interpreting complex data sets utilizing codes and programs. This includes developing codes that create analysis datasets, tables, and figures, evaluating programming processes, and suggesting revisions geared toward increasing productivity.

EEO Statement:

The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate. We also implement the EU Equality Directive to ensure an inclusive workplace.