Principal Biostatistician


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.


  • 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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Location: Ahmedabad, Gujarat

Job date: Tue, 04 Jan 2022 08:18:21 GMT

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