Principal Biostatistician - Barcelona, España - MMS

MMS

Empresa verificada

Barcelona, España

hace 1 semana

Publicado por:

Isabel García

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De jornada completa

Descripción

This is a remote, fulltime freelance consulting role.

Roles and Responsibilities

Supporting early phase clinical trials (First in Human to PoC and clinical pharmacology) support ongoing studies with clinical data analyses and reporting out for CSR. Review and creation of SAP, TFLs. Review of dry run outputs.
Experience in data analyses with SAS and R.
Ability to work independently with cross functional CTT.
Experience in multiple disease areas and in Bayesian statistical methods will be a plus.
Provide scientific/statistical insight in addressing questions from clients and propose novel solutions to technical issues
Interact with relevant stakeholders to ensure that appropriate statistical methods are adequately and consistently applied in all scientific and regulatory documents, presentations, and publications
Oversee design and execution of statistical methods (SAP), statistical analyses, and results (e.g., summary sections for clinical study reports (CSR))
Review and approve key results and statistical conclusions.
Provide guidance to the clinical and regulatory teams regarding conclusions and inferences from the data package.
Can oversee statistical deliverables such as they are consistently compliant, in timing and quality, with SOPs and departmental standards.
Performs seniorlevel reviews and is responsible for the datasets and outputs of a project. Ensures consistency with the SAP and reviews for correctness and quality.
Responsible for the statistical considerations in FDA submissions for Integrated Summary of Safety (ISS) and Integrated Summary of Efficacy (ISE), including but not limited to ISS/ISE SAP, data integration plan and oversight of all integrated analyses.
Provides high level of support to the programmers and medical writers on all statistical matters according to client requirements.
Prepares and reviews statistical methods and results sections for the clinical study report (CSR) with inhouse medical writers.
Provides support to Data Safety Monitoring Boards (DSMB) by preparing and presenting output as the unblinded statistician.
Generates sample size calculations appropriate for the primary endpoint and based on input from the protocol.
Generates and reviews randomization schedules per the protocol and randomization specifications.
Works with the project management group to ensure timelines are appropriate given the scope of the project.
Is familiar with and stays current with the latest industry practices and updated regulatory guidelines.
Communicates competently and independently with client to coordinate the statistical and programming considerations of the project.
Demonstrates strong understanding of ICH guidelines, as applicable to statistics.

Requirements:

Has experience as lead statistician for a minimum of 2 NDA submissions (including ISS and ISE)
Experience with rare disease submissions is a plus but it is not required
Has written a minimum of 2 SAPs for ISS or ISE
Has reviewed and ADRG (ADAM reviewer guide) for submissions
PhD or MS in statistics with a minimum of 5 years' experience
Experience as lead statistician on phase II/III studies for at least 5 years
Experience with writing SAP, SAP shells with great quality and mínimal support
Experience with writing ADAM datasets and CDISC
Experience with handson work checking TLFs using SAS, and assuring high quality of the deliverables
Has reviewed or written ADAM specifications for ISS, ISE
Has provided scientific/statistical insight in addressing questions from clients and propose novel solutions to technical issues.
Has a minimum of 5 years experience with using SAS
Strong knowledge of study designs and statistical analysis methods (e.g., generalized linear and nonlinear models for correlated data, survival analysis, general imputation methods, multiplicity testing).
Experience with writing statistical sections of protocols. Experience with statistical methodologies and software for adaptive designs
Excellent mathematical and problemsolving skills
Ability to coordinate the analytical aspects of multiple projects at the same time, including delegating tasks to appropriate team members
Good interpersonal, oral, and written communication skills
Selfmotivated, hardworking, dependable, and positive teamoriented personality

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