Job description

Basic Qualifications & Experience

• MSc or PhD in Statistics, Biostatistics or related quantitative sciences
• Minimum 8 years of experience as a statistician supporting clinical trials, medical affairs, or clinical development, including conducting statistical analyses from phase 3 or phase 4 studies, in an industry setting (ie. pharma, biotech, CRO)

Knowledge and Skills

• Thorough and up-to-date knowledge of statistical methods, especially those related to human clinical studies
• Thorough and up-to-date working knowledge of SAS with hands-on programming experience. Knowledge of S-PLUS or R is a plus
• Working knowledge of SDTM and ADaM data structure and CDISC standards
• Working knowledge of regulatory guidelines for drug development, NDA submissions, and statistical practices (ie. CTD guidance, ICH guidelines)
• Working knowledge of PROs; experience in psychometric evaluation is a plus
• Knowledge of HTA technical guidelines (ie. NICE DSU, IQWiG General Methods) is a plus
• Experience publishing results, including writing of abstracts and manuscripts
• Ability to manage projects, to quickly accommodate changing priorities and to meet tight deadlines while maintaining high quality standards
• Demonstrated leadership, project management, and interpersonal and negotiation skills, with excellent verbal and written communication skills
• Collaborative approach; ability to thrive in a fast-paced team environment and to work independently on projects
• Ability to explain strategies, approaches, methods, analyses, and findings to non-statisticians; ability to help others interpret results and place in context
• Ability to negotiate and advocate with strong methodological arguments with the partners to improve quality of the deliverables and interpretation
• Understanding of other functional areas as well as transversal groups and ability to maintain productive inter-function working relationships
• Experience working with external service providers
• Competencies in written & spoken English

Key Responsibilities

• Lead, design, conduct and QC post-hoc statistical analyses required for HTA submissions and pricing/reimbursement negotiations:
• Global: efficacy in target populations; health-economic modeling (cost-effectiveness); indirect treatment comparisons; post-hoc evidence to support development of Payer Value Story and Objection Handler including analyses to support identification of high burden subgroups with high likelihood of reimbursement
• Country: support country specific post-hoc requirements for health-economy modeling, and efficacy in target population and subgroups; work closely with country market access leads in coordination with Global teams; part of HTA Rapid Response team and responsible for ensuring timely completion of any requests from HTA bodies
• Present and explain statistical analyses to team members, internal forum, internal managers and/or external authors and experts
• Publication activities: Provide consultation, input and guidance to cross-functional groups charged with development and submission of manuscripts, posters, slide presentations and abstracts; work with Publication Leads and team members to respond in a timely manner to journal editor and reviewer comments
• Support clinical teams in the analyses of clinical outcome assessments (COAs), in particular patient-reported outcomes (PROs), and Health Economic endpoints for phase 2 to 4 studies, by contributing and/or reviewing protocols, statistical analysis plans, clinical study reports, and submission modules
• Psychometric assessment of COAs: Review psychometric analysis plans and reports, and serve as key statistical contact for the vendor in charge of the analyses

Job Type: Full-time

Pay: $62,001.76 - $144,668.79 per year

Benefits:

• 401(k)
• Dental insurance
• Health insurance
• Paid time off
• Vision insurance

Schedule:

• 10 hour shift
• 12 hour shift
• 8 hour shift
• Day shift
• Night shift

Ability to commute/relocate:

• Cambridge, MA: Reliably commute or planning to relocate before starting work (Required)

Education:

• Master's (Required)

Experience:

• QC post-hoc statistical: 1 year (Required)

Work Location: In person

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