Perform, plan co-ordinate and implement the following for complex studies : (i) the programming, testing, and documentation of statistical programs for use in creating statistical tables, figures, and listing and (ii) the programming of analysis datasets (derived datasets) and transfer files for internal and external clients and (iii) the programming quality control checks for the source data and report the data issues periodically..
Ability to interpret project level requirements and develop programming specifications, as appropriate, for complex studies.
Provide advanced technical expertise in conjunction with internal and external clients, and independently bring project solutions to SP teams and Statistical Programming department, for complex studies.
Fulfill project responsibilities at the level of technical team lead for single complex studies or group of studies.
Directly communicate with internal and client statisticians and clinical team members to ensure appropriate understanding of requirements and project timelines.
Estimate programming scope of work, manage resource assignments, communicate project status and negotiate / re-negotiate project timelines for deliverables.
Use and promote the use of established standards, SOP and best practices.
Provide training and mentoring to SP team members and Statistical Programming department staff.
All responsibilities are essential job functions unless noted as nonessential (N).
REQUIRED KNOWLEDGE, SKILLS AND ABILITIES
Statistical programming in SAS within the CRO / Pharmaceutical / Biotechnology / Healthcare industries
Experience as technical team lead directly engaging clients and coordinating tasks within a programming team
In-depth knowledge of applicable clinical research regulatory requirements; i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines
Knowledge of statistics, programming and / or clinical drug development process
Advanced knowledge of Base SAS, SAS / STAT, SAS Graph and SAS Macro Language
Good organizational, interpersonal, leadership and communication skills
Ability to independently manage multiple tasks and projects
Ability to delegate work to other members of the SP team
Excellent accuracy and attention to detail
Ability to delegate work to other members of the SP team SPM
Exhibits routine and occasionally complex problem solving skills
Recognizes when negotiating skills are needed and seeks assistance.
Ability to lead teams and projects and capable of managing at a group level
Ability to establish and maintain effective working relationships with coworkers, managers and clients
MINIMUM REQUIRED EDUCATION AND EXPERIENCE
or equivalent combination of education, training and experience
Extensive use of telephone and face-to-face communication requiring accurate perception of speech
Extensive use of keyboard requiring repetitive motion of fingers
Regular sitting for extended periods of time