Contributes to strategic initiatives regarding the structure and development of programming aspects of the Biostatistics department. Responsible for both management and technical aspects of programming tasks related to clinical trials. Oversees the planning and execution of programming tasks related to clinical trials/research and the statistical programming activities related to those clinical trials, including activities to support of regulatory submission by provision of CDISC standardized study data and support of ISS/ISE analyses.
ESSENTIAL DUTIES AND RESPONSIBILITIES include the following. Other duties may be assigned. Employee performs all, part, and/or any combination of the duties listed below.
Responsible for working closely with internal functions, such as Biostatisticians, Data Management, Regulatory Affairs, and Project Management.
Responsible for the development and management of Biostatistical Programming Materials (SDTM and ADaM Specifications, Programming guidelines, etc.) which may include timelines, budgets and resource requirements for the programming aspects of a trial.
Responsible for all programming of statistical analyses of clinical trials data, Phases I-IV for company work product under development, including CDISC compliant datasets, creating tables, listings, and graphs; and other relevant tools.
Serves as core team member for projects comprising a program, which includes supervising the initiation, planning, and execution of all programming related tasks awarded to the department per contract as well as monitoring the operational and financial status of the programming portion of the Biostatistics budget.
Identifies and evaluates fundamental issues for the biostatistics department and other functional areas as relevant through assessment of intangible variables.
Remains current with statistical programming developments and publications on relevant products. Applies this knowledge to current programs. Provides leadership to the development of programming for relevant department initiatives.
Provides support to the business in the development of business development and promotional materials and the training of junior biostatisticians and programmers.
Participates in corporate development of methods, techniques and evaluation criteria for projects, programs and people. May have responsibility for internal performance management of junior staff, including training, coaching and performance reviews. Acts as a mentor to junior staff.
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required.
EDUCATION and/or EXPERIENCE
A minimum of 5 years relevant statistical SAS programming experience in clinical trials is required. Must be able to demonstrate extensive experience in the execution and data analysis of clinical studies.
Bachelor's degree or equivalent, (Master’s Degree or equivalent preferred), in statistics, math, computer science, or equivalent course work in another Bachelor’s degree program.
SKILLS and/or ABILITIES
Must have a demonstrated ability to solve problems with innovative solutions along with strong organizational skills. Excellent written and verbal communication skills are required. Must be a demonstrated self-starter and team player with strong interpersonal skills. Must have strong computer skills with a proficiency in SAS (including advanced knowledge of Base SAS, SAS Macros, SAS/STAT, SAS/Graph, and SAS/SQL), Word, Excel, and PowerPoint.
Ability to read, interpret, and understand documents and reports containing pertinent information relating the clinical research protocols. Ability to respond effectively to all inquiries. Ability to write routine reports and complete clinical documentation. Ability to comprehend medical terminology. Ability to effectively communicate with data managers, biostatisticians and clinical team members, along with representatives from outside organizations.
REASONING / PROBLEM SOLVING ABILITY
Must have knowledge of clinical product development in the pharmaceutical industry. Strong analytical skills, especially with regard to programming in a clinical research organizational setting are essential. Experience and understanding of ICH, and GCP is required. Knowledge of GMP and GLP is preferred.