Director of Annuity Valuation
MassMutual
Director, Biostatistics
SDC (Statistics & Data Corporation)
full-time
Posted on:
Location Type: Hybrid
Location: Waltham • Massachusetts • 🇺🇸 United States
Visit company websiteJob Level
Lead
Tech Stack
Google Cloud Platform
About the role
- Directs departmental activities and maintains the statistical integrity of clinical trials analyzed by SDC.
- Leads efforts in writing statistical sections of protocols, preparing statistical analysis plans, preparing data deliverables for clinical study reports, interpreting analysis results, writing statistical sections of clinical study reports, and participating in meetings with drug regulatory agencies as required.
- Oversees departmental resources and budgets.
- Mentors and trains team members in their roles, emphasizing quality.
- Manage statistical and statistical programming activities involved in the design, analysis and interpretation of clinical trials data conducted by SDC.
- Supervise and direct staff, both permanent and temporary, to include assignment of work, allocation of statistical resources and management of timelines to ensure contractual obligations and objectives are met.
- Serve as a consultant with internal and external cross-functional areas regarding statistical operations.
- Function in the role as Senior Biostatistician on clinical trial(s) as required.
- Functions as a senior reviewing statistician, responsible for the timeliness and quality of departmental deliverables.
- Assess operational needs and requirements; ensure efficient allocation of resources and adequate staffing to meet goals and objectives of the department.
- Contribute to the development of standard operating procedures for clinical trials; ensure that statisticians and statistical programmers appropriately interpret and follow procedures.
- Prepare reports that summarize the analysis of data, interpret findings and provide conclusions and recommendations.
- Represent statistical operations department at regulatory meetings, sponsor meetings, and any other multifunctional meetings.
- Adheres to all aspects of the SDC’s quality system.
- Complies with SDC’s data integrity & business ethics requirements.
- Perform other related duties incidental to the work described herein.
- Adherence to all essential systems and processes that are required at SDC to maintain compliance to business and regulatory requirements
Requirements
- Experience leading ISS/ISE submissions
- Successful record of accomplishment in establishing, directing and overseeing statistical operations division/department.
- Working knowledge and understanding of ICH Guidelines for Good Clinical Practice and Title 21 of the Code of Federal Regulations Part 11.
- Skilled in analytical evaluation, organization, delegation, flexible team management, negotiating and resource management skills.
- Excellent analytical skills, with the ability to process scientific and medical data.
- Excellent knowledge of statistical programming.
- Ability to identify data issues, present problems, and implement solutions.
- Capability of communicating technical concepts clearly, concisely, and understandably to non-statistical colleagues.
- Good leadership, organizational and time management skills, with the ability to multi-task.
- Familiarity with clinical trial design and analysis activities and basic knowledge of regulatory guidelines (FDA/CFR, ICH/GCP).
- Strong interpersonal communication and presentation skills.
- Focus on quality at all times and in all situations.
- Ability to work in stressful situations and with challenging people.
- Strong teaching and mentoring skills.
- Typically a Master’s degree in biostatistics, statistics or other related, scientific field and nine years of relevant professional experience to include supervision and management experience; or equivalent combination of experience, education, and/or demonstrated ability.
Benefits
- Competitive pay
- Generous time off
- Attainable career advances
- Positive work/life balance
- 401k matching (US)
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
statistical programmingclinical trial designdata analysisstatistical analysis plansstatistical sections of protocolsstatistical sections of clinical study reportsdata deliverablesICH Guidelines for Good Clinical PracticeTitle 21 CFR Part 11analytical evaluation
Soft skills
leadershiporganizationdelegationnegotiationresource managementanalytical skillscommunicationtime managementmentoringinterpersonal communication
Certifications
Master’s degree in biostatisticsMaster’s degree in statistics
