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.
- 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.
- Performs other work-related duties as assigned.
- Minimal travel may be required
- 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.
- Excellent written and verbal communication skills.
- Ability to read, write, speak and understand English.
Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees.
FLSA status: Exempt
Years of experience required: 4- years of experience
Physical Requirements: Position requires: ability to occasionally move about inside the office to access filing cabinets, office equipment, etc. and to move between office locations; ability to maintain a stationary position for prolonged periods of time; ability to occasionally manipulate (e.g., lift, carry, move) office items and packages of light to medium weights of 10-35 pounds; ability to constantly operate a computer and other office productivity equipment (e.g., scanner, phone, printer, copier); ability to perceive and assess written materials for prolonged periods of time; and ability to frequently communicate with colleagues on the phone, by email, and in-person.
Work Environment: This job operates in a professional office environment. This role routinely uses standard office equipment such as computers, phones, photocopiers, and filing cabinets. The noise level in the work environment is low. This is a largely sedentary role.