Principal Biostatistician

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 on-going 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 senior-level 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 in-house 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 define.xmls 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 hands-on 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 problem-solving 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
- Self-motivated, hardworking, dependable, and positive team-oriented personality

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