General Summary
Under general supervision of the Statistics Manager or higher, the Principal Statistician is the lead statistician on clinical studies and is responsible for all statistical deliverables for assigned trials. This person will provide scientific and statistical expertise for the design, analysis, and reporting of scientific research trials. This person will also represent Statistics on project teams to provide functional area input to and ensure alignment with functional management.
Specific Duties and Responsibilities
•Independently recommend appropriate research design, definition of patient populations, measurement of outcome variables, and hypothesis development on assigned trials. *
•Act as the liaison for statistical issues with steering and/or data monitoring committees, investigators, and medical/scientific experts. *
•Assume responsibility for individual studies, author and provide input on relevant sections of clinical research protocols, including endpoint specification, sample size determination and justification, randomization plans, statistical analysis plans, interim analysis, and stopping rules. *
•Prepare key sections of clinical study reports and various regulatory documents.
•Drive submission activities and documents, provide input on responses to regulatory authorities and other device development activities, as required. Author statistical analysis plans, including development of table and listing shells. Review statistical analysis plans written by contract or junior statisticians. *
•Prepare key sections of clinical study reports and regulatory documents. Perform statistical QC of final clinical study reports. *
•Review CRFs to ensure consistency with protocol and adequacy in collecting data to meet objectives and statistical analyses defined in the protocol.
•Collaborate with study leads and investigators in the preparation of abstracts, oral and poster presentations, and publications relating to the results of clinical studies. *
•Participate in planning and execution of randomization and un-blinding activities. *
•Provide data for review by outside safety panels such as Data Safety Monitoring Boards. *
•Represent statistics function in discussions at conferences and investigator meetings.
•Lead the generation/validation of analysis datasets, tables, figures, and listings to support the submission of clinical trial data using SAS/R.*
•Use statistical software such as SAS and R to create and maintain listings, tabulations, graphical summaries, and formal statistical estimates and tests. *
•Provide programming support to supplemental or exploratory analyses for regulatory agencies or any other internal and external ad-hoc requests. *
•Responsible for identifying opportunities for productivity improvements and formulating implementation plans. Independently develop new processes. *
•Interact with data management, statistical programmers, clinical affairs, medical affairs, regulatory affairs, quality assurance staff, and external data analysis vendors.
•Serve as the as the SME for statistical methods, collaborate with other functional groups and explain statistical concepts in an easily understandable way to non-statisticians and provide adequate statistical justifications for actions/decisions/statements, when required.
•Remain current with statistical methods and trial design issues. Proactively implement new statistical methods on assigned trials and share such knowledge with other company statisticians.
•Adhere to the Company’s Quality Management System (QMS) as well as domestic and global quality system regulations, standards, and procedures. *
•Understand relevant security, privacy and compliance principles and adhere to the regulations, standards, and procedures that are applicable to the Company. *
•Ensure other members of the department follow the QMS, regulations, standards, and procedures.*
•Perform other work-related duties as assigned.
*Indicates an essential function of the role
Required Qualifications
Minimum Education and Experience:
•Masters’ degree in Statistics, Biostatistics, Math or related field with 5+ years of
experience, or equivalent combination of education and experience.
•5+ years of experience in clinical trial analysis in a medical device or pharmaceutical environment.
•Working knowledge of computer programming and software programs (e.g., SAS, R) required.
Additional Qualifications:
•Prior experience working on device pre-market approvals, IDE, and HDE submissions to CDRH is preferred.
•Understanding of FDA regulatory requirements and ICH/GCP preferred.
•Experience analyzing complex study objectives and developing appropriate analysis specifications and plans.
•Experience writing, reviewing and approving statistical analysis plan (SAP) from the clinical protocol and other study specific documents.
•Experience of developing statistical reports for industry conferences, regulatory submissions, and for internal reviews.
•High degree of accuracy, organizational skills and attention to detail are essential.
•Excellent oral, written, and interpersonal communication skills.
Working Conditions:
•General office environment.
•May have business travel from 0% - 15% to research or laboratory hospitals.
•Potential exposure to blood-borne pathogens.
•Must be able to move between buildings and floors.
•Must be able to remain stationary and use a computer or other standard office equipment, such as a printer or copy machine, for an extensive period of time each day.
•Must be able to read, prepare emails, and produce documents and spreadsheets.
•Must be able to move within the office and access file cabinets or supplies, as needed.
•Must be able to communicate and exchange accurate information with employees at all levels on a daily basis.
Annual Base Salary Range: $169,000 - $243,000
This is the pay range for a mid-cost labor market. If hired in another region, there will be a difference in pay range. We offer a competitive compensation package plus a benefits and equity program, when applicable. Individual total compensation will vary based on factors such as qualifications, skill level, competencies, and work location.
What We Offer
•A collaborative teamwork environment where learning is constant, and performance is rewarded.
•The opportunity to be part of the team that is revolutionizing the treatment of some of the world's most devastating diseases.
•A generous benefits package for eligible employees that includes medical, dental, vision, life, AD&D, short and long-term disability insurance, 401(k) with employer match, an employee stock purchase plan, paid parental leave, eleven paid company holidays per year, a minimum of fifteen days of accrued vacation per year, which increases with tenure, and paid sick time in compliance with applicable law(s).
Penumbra, Inc., headquartered in Alameda, California, is a global healthcare company focused on innovative therapies. Penumbra designs, develops, manufactures, and markets novel products and has a broad portfolio that addresses challenging medical conditions in markets with significant unmet need. Penumbra sells its products to hospitals and healthcare providers primarily through its direct sales organization in the United States, most of Europe, Canada, and Australia, and through distributors in select international markets. The Penumbra logo is a trademark of Penumbra, Inc.
Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, sexual orientation, gender identity, age, disability, military or veteran status, or any other characteristic protected by federal, state, or local laws.
