Sr Program Manager, Biostatistics

POSITION SUMMARY:

This position will be accountable for the leadership of the Biostatistics and Programming activities of a program of studies of high complexity, and/or of high value with high impact for the organization, including:

• Biostatistical input into the clinical development plan of the program 
• Protocol input such as study design, sample size calculations and patient randomization schemes
• Statistical aspects of case report form design
• Reviews study database structures, edit checks and data management coding conventions
• Preparation of statistical analysis plans including the definition of derived data, and the design of statistical tables, figures, and data listings for clinical summary reports
• Statistical analyses
• Interpretation of data and reporting of results
• Writing of the statistical methods sections of integrated study reports
• Integrated summaries of safety and efficacy
• Supports responses to regulatory questions on the design the design of the program, and any labelling claims following submission

The program of studies will typically lead to a regulatory submission and be for one of ICON’s Strategic Clients.

The position is accountable for planning, monitoring, organizing and reviewing activities of biostatisticians and programmers working on the assigned program of studies, ensuring individual studies and the overall program of studies and integrated analyses are delivered on time, on budget to required quality. Accountabilities also include maintenance of consistency across studies.

JOB RESPONSIBILITIES:

• Recognize, exemplify and adhere to ICON's values which centers around our commitment to People, Clients and Performance.
• As a member of staff, the employee is expected to embrace and contribute to our culture of process improvement with a focus on streamlining our processes adding value to our business and meeting client needs.
• The employee is expected to recognize the importance of and create a culture of process improvement with a focus on streamlining our processes adding value to our business and meeting client needs.
• Travel (approximately 5%) domestic and/or international

Accountable for the following tasks per agreed timelines and to required quality levels:

Accountable for the Biostatistics and Programming activities for a program of studies of high complexity and/or of high value with high impact, including:

Biostatistical input into the design of the program

• Protocol input such as study design, sample size calculations and patient randomization schemes
• Statistical aspects of case report form design
• Reviews project database structures, edit checks and data management coding conventions
• Preparation of statistical analysis plans including the definition of derived data, and thE design of statistical tables, figures, and data listings for clinical summary reports
• Statistical analyses
• Interpretation of data and reporting of results.
• Writing of the statistical methods sections of integrated study reports.  Reviews draft integrated study reports.
• Integrated summaries of safety and efficacy
• Supports responses to regulatory questions on the design of the program, and any labelling claims following submission

This includes ensuring activities are of high quality, within budget and on time completion, and  maintaining a consistent approach across studies.

• Liaises regularly with biostatistics/programming study/program leads to ensure support on key discussions (timelines…etc.) and early warning to senior management of programming issues (resource/project issues...etc.)
• Liaises regularly with the programming program lead to ensure program level programming solutions are being identified and implemented.
• Ensures that all work is carried out in accordance with ICON SOPs. Develops program specific procedures (SSPs) as required and ensures that team members adhere to the SSPs.
• Documents and archives analysis and programming work to ensure a complete audit trail.  Participates in the setting of program level document standards.
• Creates and maintains biostatistics files for the program and each study.

In addition to the requirements outlined above, the Biostatistics, Program Director will perform the following tasks:

• Establishes and maintains effective working relationships with clients and ICON project team members, including data management personnel, statistical programmers, and clinical research personnel.
• Participates in presentations at client and investigator meetings.
• Preparation of biostatistics input to ICON research proposals, and participates in proposal defense meetings and makes presentations at marketing meetings with prospective client. 
• Researches and applies new statistical procedures as needed.
• Assists in technical training of new staff.
• Ongoing coaching and mentorship of team members.
• Embrace and lead departmental process improvement initiatives with a focus on streamlining our processes adding value to our business and meeting client needs.
• Performs additional duties as assigned.

JOB REQUIREMENTS:

• 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. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
• In-depth knowledge of study designs, and statistical analysis applications in one or more therapeutic areas.
• Excellent verbal and written communication skills are required. 
• Excellent knowledge of a wide variety of principles, theories and concepts in statistics and experimental design; must be able to apply them to the development and analysis of clinical trials
• Excellent knowledge of clinical trials methodology, regulatory requirements, statistics and statistical software packages, including SAS are a must.
• Experience of leading a regulatory submission
• Must be able to translate clients’ needs into statistical practice and educate clients in the use of statistics.
• Excellent interpersonal and project management skills

EDUCATION:

M.S. degree in statistics, biostatistics, or related field with at least 12 years of relevant experience (at least 10 of which must be in the pharmaceutical industry); or Ph.D. in statistics, biostatistics, or related field with at least 10 years of relevant experience (at least 8 of which must be in the pharmaceutical industry).