Statistical Scientist (100% Remote)

Job Description:

Purpose and Scope:

Member of cross-functional teams, the primary purpose of the position is to act independently as Study Statistician / Medical Affairs Statistician (MA) / Exploratory Statistician / Regional Statistician Lead (RSTATL) or Lead Product Statistician (LPS) for routine works in an established area (clinical/ observational studies, MA tactic, Biomarker & PK/PD Analyses or local project). The position can also act as a Senior Methodology statistician independently validating the execution of complex common techniques, offering training/consulting to other statisticians, or researching solutions for novel situations.

The position is expected to understand when to seek Global Statistical Lead (GSTATL) and/or line management intervention to ensure successful outcome with respect to resource requirements or key strategic functional issues. Under guidance, this position may act as GSTATL, or represent the company on statistical matters at meetings with regulatory authorities, key opinion leaders, HTA or conferences.

Responsibilities and Accountabilities:

Contributes to the efficient planning, execution and reporting of clinical/observational studies, post hoc analyses, HTA analyses, regional analyses, PK-PD and Biomarkers analyses

• Translates scientific questions into statistical terms and is responsible for the quality and timeliness of corresponding statistical deliverables
• Independently provides statistical advice related to study design, selection of endpoints, population, PK/PD or biomarkers for routine studies.
• Authors or reviews protocol, statistical analysis plans (Biomarker, PRO, HTA), Care Report Form, Data Validation Plans, tables listings and figure (TLF) specifications, statistical analyses, clinical study reports, and associated publications (to check the correct interpretation of the data)
• Under the supervision of an experienced statistician, may support more complex studies or asset level analyses (i.e., integrated summaries, regulatory, payer dossier and publications)

Personal development / Collaboration

• Contributes to cross-functional or indication level improvement initiatives (i.e., write SOP - select, validate and implement statistical software - standard output generation - creation of, maintenance and adherence to indication specific standards).
• Collaborates and communicates effectively with the other Data Science functions; in particular the position provides Statistical Programmers with study details, timelines, specifications, efficacy analyses algorithms. Close partners, the statistician and programmer communicate frequently and update each other and other team members on progress of individual deliverables.
• Is responsible to develop a reliable network of academics, regulators and industry peers as well as investigate and share new statistical methodology

Required Qualifications:

• PhD or M.S in Biostatistics, Statistics or related scientific field
• 3+ years (6+ years for MS) of experience in applying statistical methods in biomedical research, Pharma, CRO, Academia or Healthcare industry or in providing statistical direction in these areas
• Good knowledge and skills in SAS required, knowledge of R preferred
• Good understanding of medical literature, clinical, regulatory, and commercial landscape
• Ability to understand, implement, and explain complex statistical methodology