Senior Principal Statistician

POSITION SUMMARY:

Reporting to the Vice President, Clinical Affairs and Biometrics, the Senior Principal Statistician is responsible for providing Statistics/Statistical Programming services. The Senior Principal Statistician will work closely with regulatory, scientific affairs, health economics, medical affairs and other departments to ensure optimal study designs, data collection and analysis for regulatory agencies and other stakeholders. This individual will be responsible for statistical programming deliverables: SAP, derived datasets, Tables, Figures and Listings.

The Senior Principal Statistician will establish and ensure compliance with standard processes and industry best practices.

ESSENTIAL FUNCTIONS OF THE POSITION:

• Supports the design, analysis, and reporting of trial results
• Develops statistical methodology for studies, including power analysis, randomization schemes, and statistical analysis plan, subgroup analysis, interim analysis, etc.
• Ensures data collection instruments are designed to capture protocol-specified scientific information and study databases
• Effectively presents statistical concepts, evidence, interpretations, and logical arguments to the project team, management, and regulatory agencies
• Develops program verification procedures and plans to provide thorough and detailed reviews of documentation and analysis output
• Delivers appropriate, accurate and understandable line listings and statistical tables, and preparation and review of statistical sections of study reports and submission reviews
• Programming and validation of derived datasets Tables, Figures and Listings
• Oversees work of statistical programmer and CRO/vendor deliverables
• Manages statistics/statistical programming resources to meet assigned project priorities
• Contributes to development of timelines and budgets across functional teams to ensure timely submissions aligned with our objectives
• Works in close collaboration with Data Management and contributes to the development of CRFs. DMP and other DM deliverables
• Provides statistical input and review for APRs, CSRs, publications to ensure the accuracy of the statistical component of scientific reports with high quality
• Develops and routinely reviews Statistics/Statistical Programming SOPs to ensure adequate processes are in place to manage quality work in line with regulations.
• Participates in regulatory submission process, including IDEs and 510(k)
• Hires, mentors, manages and evaluates activities of statistics/programming personnel as necessary
• Manages personnel by appropriately delegating assignments, reviewing activities and defining and ensuring review of deliverables so that projects are completed on time with high quality

ADDITIONAL ESSENTIAL FUNCTIONS OF THE POSITION:

• Regular and predictable work performance
• Ability to work under fast-paced conditions
• Ability to make decisions and use good judgment
• Ability to prioritize various duties and multitask as required
• Ability to successfully work with others
• Additional duties as assigned

BASIC QUALIFICATIONS:

• MS/PhD in Statistics, Biostatistics or a related field. At least 3-5 years (PhD) or 6-10 years (MS) experience in medical device, biotech or pharmaceutical development. Minimum of 2 years of management experience. Knowledge of statistical methodology. Expertise in medical device product development and experience interacting with regulatory agencies highly desirable
• Good communication skills, both oral and written
• Knowledge of design, data analysis methodology, SAS programming to meet FDA and ICH guidelines
• Knowledge of programming Tables, Listings and Figures in SAS for FDA submission
• Good know of SAS, R and Sample size calculations software
• Ability to work independently
• Ability to travel 10%

PREFERRED QUALIFICATIONS:

• PhD in Statistics, Biostatistics or a related field with at least of 4 years of experience in medical device, biotech or pharmaceutical development
• Minimum of 2 years of management experience
• Experience interacting with FDA and other regulatory agencies
• Statistician with comprehensive experience in programming TLFs for regulatory submissions
• Experience in supporting 510K, IDE, PMA, NDA, BLA, and or CTD submission

OTHER REQUIREMENTS:

• Ability to regularly walk, sit, or stand as needed
• Ability to occasionally bend and push/pull as needed
• Ability to pass pre-employment drug screen and background check

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