Senior Statistical Programmer

Senior Statistical Programmer

Education: BSc or equivalent (preferably in Statistics, Computer Science, or Mathematics). Master’s Degree preferred.

Experience:  A minimum of 5 years industry experience with good knowledge of SAS BASE, STAT, MACRO, SQL, Graph, CDISC guidelines, ICH Statistical and Clinical Report Guidelines. Relevant experience with at least one Therapeutic Area and skilled in the production/qc of SDTM / ADaM / ADaM’s like Datasets, Tables, Listings and Figures. Experience working on interim data with compressed timelines, i.e., for a DMC meeting, as required.

Skills: 

• Good problem-solving skills.
• Good project management, organizational and presentation skills required.
• Detail-oriented with an observational and analytical mind-set.
• Fluent in English; good verbal and written communication skills
• Very good interpersonal skills with the ability to establish and maintain effective working relationships with coworkers, managers and clients.
• Ability to manage competing priorities and adapt to change.
• Good knowledge of the pharmaceutical industry including understanding of clinical drug development process, regulatory requirements,  interdependencies with other functions.
• Proficient in SAS programming. R or Python programming skills a plus.

Responsibilities: 

• Contribute to statistical programming activities required for a DMC meeting; program and/or QC statistical deliverables (Datasets, Tables, Listings and Figures) for statistical analysis.
• Develop program specifications and design documents 
• Provide leadership in organizing teamwork, prioritizing and balancing concurrent tasks and responsibilities ensuring high quality, respecting timelines and adherence to the budget under the direct support and supervision of a programming manager
• Attend relevant project meetings and work closely with other internal and external leads.
• Identify risks to project deliverables and timelines, develop and implement the mitigations for these risks.
• Provide guidance to less experienced staff members with respect to statistical programming strategy, deliverables and processes.
• Utilize project management skills to serve as key collaborator with project stakeholders in ensuring appropriate understanding of project requirements, scope of work and timelines. 
• Participate in project review meetings.
• Ensure monthly financial compliance. 
• Serve as statistical programming point of contact and knowledge holder through the entire product lifecycle for the assigned protocols if/when called upon.
• Responsible for quality control and audit readiness of all assigned statistical programming deliverables as well as accuracy and reliability of statistical analysis results. 
• Understand and follow all relevant standard operating procedures (SOPs).
• Understand and adhere to project specific clinical protocol(s): the clinical design, randomization schedule, per protocol analysis, statistical analysis, primary and secondary variable etc., 
• Ensure understanding and adherence to clinical Statistical Analysis Plan (SAP):  describing how the clinical trial data will be analyzed (defines the study population, presents data windowing or other special data handling rules and often includes draft output shells that show precisely what tables, listings and graphs will be provided in the reporting). 
•  Keep abreast of current and new statistical programming techniques and other applicable technical advancements while assisting in their implementation. Maintain up-to-date knowledge of programming software (e.g. SAS, R, Python) as well as industry requirements (e.g. CDISC, eCTD,...), attend functional meetings and trainings.
• Assist with the recruitment process as required.