Biostatistics, Subject Matter Expert
Company: parexel
Location: Wasilla
Posted on: February 25, 2021
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Job Description:
Job DescriptionThe Biostatistics, Subject Matter Expert is
responsible for statistical consulting, strategic advice and
operational execution in drug/device /diagnostic developments up to
submissions and approvals as well as successful reimbursement
applications. The Biostatistics SME serves as an executive sponsor
for enterprise and biotech accounts promoting client engagement. *
Leads and contributes to strategic initiatives and working groups
within GDO and Biostatistics and Statistical Programming to build a
world-class group of Biostatistics experts. * Responsible to
actively promote new business by participating in project bids and
client presentations as appropriate. The Biostatistics SME works
closely with Business Development and Solutions Consultants to
promote Biostatistics engagement to drive new business. The
Biostatistics SME is an experienced leader responsible for liaising
with senior levels of management within the organization and to
deputize for the Vice President or Corporate Vice President as
needed. Qualifications Skills: * Excellent organizational,
communication, negotiation, problem-solving, analytical and
consulting skills * Technical leadership and contribute to a high
performing team * Expertise in optimizing trial design, development
programs, submission strategies and regulatory interactions *
Outstanding understanding of the drug, device or diagnostic
development process * Expertise in broad different therapeutic
areas and indications * Thorough understanding of various
statistical models and applications * Excellent understanding of
statistical issues in clinical trials and strategies to avoid them
* Thorough understanding of regulatory guidance and practices
pertaining to specific indications and to submissions and approval
processes * Thorough understanding of e-submissions, eCTD, etc *
Thorough understanding of ICH guidelines * Excellent knowledge of
all statistical and reporting processes within the Biostatistics
department. * Strategic awareness of our business environment *
Knowledge of the International pharmaceutical market and the
services required by sales, marketing and operational support to
achieve product success * An ability to assess situations and make
and carry through difficult decisions * Advanced ability to
successfully manage a full workload across multiple projects *
Excellent interpersonal, verbal and written communication skills
(including experience in making presentations at conferences,
meetings, training sessions) * Demonstrable experience of
stakeholder/relationship management with a client focused approach
to work. Able to understand the business implications of decisions
and impact on customer * Advanced ability to manage multiple and
varied tasks with enthusiasm and prioritize workload with attention
to detail * Advanced ability to work in a matrix environment and to
value the importance of teamwork * Comprehensive knowledge of
relevant software: Windows, Word, Excel, Outlook Knowledge and
Experience : * 15 + years of experience in the pharmaceutical
industry, with broad clinical development and therapeutic area
knowledge * Direct experience in consulting * Proven record and
experience with development, execution and implementation of
research strategies in the pharmaceutical industry * Experience in
designing and executing drug, device or diagnostic development
programs * Demonstration of successful direct interactions with
relevant regulatory agencies like FDA/EMEA/PMDA or other local
agencies * Experience with regulatory submissions and negotiations
during the regulatory review process, including Advisory Committee
preparation and participation * Experience with conference
presentation and manuscript writing Education: * PhD in Statistics
or related discipline, MS in Statistics or related discipline EEO
DisclaimerParexel is an equal opportunity employer. Qualified
applicants will receive consideration for employment without regard
to legally protected status, which in the US includes race, color,
religion, sex, sexual orientation, gender identity, national
origin, disability or protected veteran status.
Keywords: parexel, Anchorage , Biostatistics, Subject Matter Expert, Other , Wasilla, Alaska
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