Description

JOB SUMMARY
This position functions as a member of the Biostatistics and Statistical Programming project team serving
as a Lead Statistical Programmer for projects of any complexity 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; assists in managing project budgets and tracking project
specific performance metrics; functions as an internal and external customer liaison; provides input to the
statistical analysis plan; leads the creation and maintenance of statistical programming project
documentation.
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 and
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.
Prepares in advance for internal meetings, contributes ideas, and demonstrates respect for opinions
of others.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.
Negotiates and establishes accurate time estimates for completion of study programming activities
with internal team members and statistical programming management, and completes project
programming activities within timeframe allotted.
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.
Transfers deliverables.
Performs other work-related duties as assigned.
Minimal travel may be required

Qualifications

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.
Negotiates and establishes accurate time estimates for completion of study programming activities
with internal team members and statistical programming management, and completes project
programming activities within timeframe allotted.
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.
Transfers deliverables.
Performs other work-related duties as assigned.
Minimal travel may be required

As a healthcare company we have an important responsibility to protect individual and public health. This position will require individuals to be fully vaccinated against COVID-19 as part of their job responsibilities, unless an exemption can be confirmed based on a medical condition or sincerely held religious belief. Submission & Approval of an Exemption does not guarantee that an exemption can be accommodated.