Overall Job Description:
Ensure design, data analysis and interpretation by Philips for the purpose of research (particularly regulatory and marketing claim substantiation, during clinical evaluations, studies, and trials) is high quality and in compliance with regulatory body standards. The function is part of Global Biostatistics and Data Management within Clinical and Medical Affairs.
Key areas of responsibility:
• Lead biostatistics activities (Design, Interpretation, Infrastructure).
• Oversee, mentor, and help develop group of internal Biostatisticians and Consultants.
• Lead protocol development with an emphasis on study design and sample size calculations.
• Lead in Statistical Analysis Plan development and management.
• Lead in CRF and database specification development in conjunction with programming and data management.
• Lead in the review and development of tables, listings, and figures as specified in the Statistical Analysis Plan.
• Lead with the creation of ad hoc analyses and summaries as requested.
• Provide data cleaning support for the data management effort.
• Involved in the QC of all the deliverables created by programming and statistics (e.g. output, the statistical section in the study report).
• Build successful relationships and seamless interfaces at the protocol / project team level, and provide timely and effective communication to the study team / trial manager and functional leads.
• Provide input for the technical infrastructure of the biostatistics function.
• Develop and implement strategy for the improvement of productivity and standardizing of biostatistical activities.
• Lead in developing, applying and promoting consistent standards through standard processes and SOPs.
• Ensure guidelines and specifications regarding statistical practices are followed, and ensure the maintenance of appropriate documentation.
• Interface closely with Statistical Programming and Data Management on the project level.
• Able to work independently.
• The ability to travel up to 15% of time.
• Other Duties as assigned.
Requirements for the Position:
• MS Degree in the Biostatistics discipline with a minimum of 3 years of experience in the device / pharma industry.
• Experience with Base SAS, SAS/STAT, SAS Macro language, SAS/GRAPH, and in general excellent computer skills.
• Coding dictionary experience preferred.
• Strong communication skills, both verbal and written.
• Strong scientific background and understanding of clinical trials, pharmaceutical / device operations, and regulatory compliance.
• Practical knowledge of ICH, FDA, and GCP regulations and guidelines.
• Proven ability to take independent action to initiate process improvement, when needed.
• Proven ability to work in a matrix-like manner where cross-functional interaction is implicit.
• Proven ability to deliver on delegated work efficiently.
• Solid time-management skills to meet deliverables commensurate with a fast-paced environment.
• Well organized, able to multitask and prioritize competing tasks.
• Able to manage expectations with supervisors, peers and customers.
• Experience in leading cross-functional teams
• Excellent verbal / written and interpersonal skills required for working successfully in a cross-functional team environment
• The ability to communicate and collaborate effectively with cross-functional teams in face-to-face conversation, by telephone, and by email
• The ability to act independently to determine methods and procedures on new assignments
• Proven ability to work in a matrix-like manner where cross-functional interaction is implicit
• Proven ability to deliver on delegated work efficiently
• Solid time-management skills to meet deliverables commensurate with a fast-paced environment
• Well organized, able to multitask and prioritize competing tasks
• Able to manage expectations with supervisors, peers and customers
• Ability to deliver results in a timely manner
• Open to learning