Senior Biostatistician

This project received 2 bids from talented freelancers with an average bid price of $30 USD / hour.

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Project Budget
$2 - $100 USD / hour
Total Bids
Project Description

MMS Holdings Inc., a growing pharmaceutical service organization (CRO), that focuses on regulatory submission support for the pharmaceutical, biotech and medical device industries. We are a pharmaceutical service provider supporting pharmaceutical and biotech industries with medical writing, biostatistics, clinical programming, data management, clinical development, regulatory affairs, regulatory submissions and pharmacovigilance.

Regent's Place

338 Euston Road

London, England NW1 3BT

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 mento

• 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

Desired Skills & Experience

• College graduate in statistical discipline, computer science or related field, or related experience

• Has high level knowledge of drug development as it pertains to biostatistics; has the ability to apply drug development knowledge during production of high quality statistical analyses

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

• Strong experience with data and production of TLGs

• Strong programming and logic skills

• Experience in pharmaceutical or CRO industry preferred

• Strong SAS programming, SAS base, SAS macro experience

• Thorough knowledge and understanding of clinical data preferred

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

• Strong resource for biostatistics; willing to guide others in a variety of biostatistical techniques

• Excellent scientific writing skills

• Proficiency with MS Office applications

• Excellent organizational and communication skills

• Familiarity with ISO 9001:2008 requirements

Skills Required

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