Senior Biostatistician

Sr. Biostatistician or above, with 5-8+ years of relevant CRO industry experience.

Education: PhD 5+ years of experience or Masters 8+ years of experience

Location: Remote (US Based)

Compensation: Competitive

Key Accountabilities:

• This position is accountable for applying and/or providing expertise in statistical, programming, and data management methods and techniques to effectively enable decision making in support of the company’s mission, strategies, customers and priorities.
• Lead efforts in resolving day to day work related issues and problems, improving efficiency, quality, and productivity of the operation, enhancing customer relationship and improving customer satisfaction level on our services. These efforts may include, but are not limited to, the following:
• Research and development of statistical methodologies.
• Investigate and implement new technologies, processes and procedures.
• Participate in developing and executing marketing strategies and plans (trade shows, publications/presentations, corporate website design and maintenance, meeting with existing and new clients).
• Participate in developing and executing customer relationship management plans.
• Participate in business development and maintenance activities.
• Perform review for clinical study protocols and statistical, programming, and data management documents generated by others.
• Lead assigned projects by applying project management skills, statistical, programming, and data management techniques to facilitate better decision making, improve business operations and discover, improve, develop or defend new or existing products.
• Plan, develop and monitor timelines for statistical, programming, and data management activities in accordance with medical/clinical activities for assigned projects. Jointly with immediate management, assess statistical, programming, and data management resource needs and manage the assigned resources.
• Provide statistical and data management input into protocol development. Write Statistical Analysis Plans for assigned projects. Oversee IVRS and web-based patient randomization processes for assigned projects.
• Oversee the development of Data Management Plans (DMPs) for assigned projects.
• Provide statistical input into Case Report Forms (CRF) design for assigned projects, and oversee efforts in developing, reviewing and testing of the CRFs.
• Provide statistical and programming input into database design for assigned projects, and oversee efforts in development, validation and testing of the study databases.
• Participate in Study Manual Development, and in clinical trial initiation meetings such as investigator meetings, site monitor/coordinator training sessions. Address statistical, programming, and data management questions/concerns from the meeting participants. Train site personnel on data management requirements and procedures.
• Oversee data management and programming activities for assigned projects. Serve as primary contact between medical/clinical and data management in data related issues.
• Oversee programming support activities for assigned projects. Validate the accuracy, consistency and integrity of the statistical output displays generated by the Study Programmer.
• Perform statistical data analyses. Write statistical and data management sections of the joint medical and statistical Study Reports for assigned projects.
• With assistance from the Archivist, archive study documentation upon the completion of final Clinical Study Reports.
• Participate in evaluating the performance of assigned project personnel.
• Follow up on the development and implementation of new statistical, programming, and data management methodologies which will improve current/future decision making or divisional/corporate business processes, and on the statistical/data management related regulatory requirements and practices.
• Participate in the development and maintenance of and adhere to divisional SOPs and guidelines.
• Participate in the development and maintenance of and adhere to therapeutic area specific standards and conventions.
• Participate in the development and maintenance of and adhere to corporate policies and SOPs.
• Plan and carry out professional development.

Qualifications and Experience:

• A Ph.D. degree or equivalent in statistical science, mathematical analysis or related field plus 4-5 years relevant experience
• A master’s degree plus 6 to 7 years relevant experience with demonstrated ability and sustained performance.