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Senior Biostatistician

MMSH Clinical Research Pvt.Ltd is part of MMS Holdings Inc. a global clinical research organization (CRO) that focuses on regulatory submission support for the pharmaceutical, biotech and medical device industries. Our strong industry experience and scientific approach to drug development makes us a valuable partner in creating compelling submissions that meet rigorous regulatory standards. Our clients span from top 10 pharma to virtual biotechs, and we support each one with the same standard of excellence. Our core service areas include medical and regulatory writing, biostatistics, clinical programming, data management, clinical development, clinical trial disclosure, regulatory affairs, regulatory submissions and pharmacovigilance.

Our mission is to deliver high-quality services, rooted in good science and decades of regulatory experience, that will assist our clients in developing and marketing life-changing therapies, thereby positively affecting patients' lives worldwide.

Please send your resume and mention your current as well as expected salary. Home office can be considered

Roles & Responsibilities:

• Practices good internal and external customer service

• Responsible for implementation and execution of high quality client statistical analyses

• Demonstrates strong understanding of ICH guidelines, as applicable to statistics

• Creates statistical training exercises, trains new biostatisticians, and serves as a mentor

• Trains via self-study and self-practice independently and explores advanced topics related to biostatistics and/or drug development

• Utilizes System Development Life Cycle (SDLC) for statistical deliverables

• Interacts directly and independently with client to coordinate all facets of the project; competent communicator

• Provides high level of support to the programmers and medical writers on all statistical matters according to client requirements

• Provides advanced input into statistical sections of the protocol

• Development Plan per client requirement

• Develops statistical analysis plan (SAP) and assist in preparing the data validation plan based on guidance from client

• Works with programming team to provide definitions, documentation, and review of derived variables needed to produce planned tables, listings, and graphs (TLGs

• Develops data and programming specifications jointly with programmers

• Assists in designing data presentations including summary tables, graphs, and subject listings

• Monitors data quality from a study conduct and output perspective

• Performs statistical analysis according to the SAP, validates analysis programs, reviews TLGs, prepares statistical methods and results sections for the clinical study report (CSR)

• Performs and/or coordinates and oversees the preparation, execution, reporting and documentation of all analyses (interim and final)

• Assists in writing efficacy sections of clinical study reports and summary documents with in-house medical writers and the client’s study team

• Assumes responsibility for quality and statistical integrity of clinical study reports and summary documents

• Performs analyses and prepares data presentations for clinical registration dossiers based on strategies developed by the client

• Independently implements and validates QC findings in compliance with the NC Handling Procedure

Requirements

• Master of Science (in statistics of equivalent) with five (5) plus years related work experience or PhD (in statistics of equivalent) with three (3) plus years of relevant years of work experience

• Proficient knowledge of/ experience with SAS/ R/ Splus or any other business or research analytical software

• Proven knowledge in drug development

• Strong hands-on experience with clinical trial and pharmaceutical development

• Strong experience with data and production of TLGs

• Proficient in up-to-date statistical knowledge/ applications and advance expertise in analytic aspects

• Deep knowledge of data architecture

• Experience in pharmaceutical or CRO industry preferred

• Strong SAS programming, SAS base, SAS macro experience

• Solid experience in leading analytic support for multiple trials

• Familiarity with graphical software (e.g., SigmaPlot)

• Proficiency with MS Office applications

• Good interpersonal and communication skills

• Familiarity with ISO 9001:2008 requirements

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