Principal Biostatistician

March 24, 2022 WORK FROM HOME

Job title: Principal Biostatistician

Company: MMSH Clinical Research Pvt Ltd

Job description: MMS is an award-winning, data-focused CRO that supports the pharmaceutical and biotech industries with a proven, scientific approach to complex trial data and regulatory submission challenges. Strong industry experience and a data-driven approach to drug development make MMS a valuable CRO partner, creating compelling submissions that meet rigorous regulatory standards. With a global footprint across four continents, MMS maintains a 97 percent customer satisfaction rating and was named as the Best Global Biotech CRO in the 2018 International Life Sciences Awards. For more information, visit our websit e or follow MMS on LinkedIn .

Roles and Responsibilities

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

PhD in statistics with a minimum of 5 years of experience or MS in statistics or related field with 12 years of experience preferred.
Experience as lead statistician on phase II/III studies for at least 5 years
Experience with writing SAP, SAP shells with great quality and minimal 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 experience as lead statistician for a minimum of 2 NDA submissions (including ISS and ISE)
Has written ADAM specifications for ISS, ISE
Has written a minimum of 2 SAPs for ISS or ISE
Has provided scientific/statistical insight in addressing questions from clients and propose novel solutions to technical issues.
Has developed BIMO package
Has reviewed define.xmls and ADRG (ADAM reviewer guide) for submissions
Has a minimum of 5 years experience with using SAS
Experience with rare disease submissions is a plus but it is not required
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
Good interpersonal, oral, and written communication skills
Self-motivated, hardworking, dependable, and positive team-oriented personality
Bayesian analysis experience is a plus

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