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Director of Biostatistics

Company: Premier Research Group Limited
Location: Atlanta
Posted on: September 17, 2020

Job Description:

Company: Premier Research Group Limited

Location: Atlanta

Posted on: September 12, 2020

Job Description:

Position at Premier Research Group Limited

Premier Research helps highly innovative biotech and specialtypharma companies transform life-changing ideas into reality. Wehave positioned ourselves right in the middle of the action,targeting unmet needs in Analgesia, Neuroscience, Oncology,Dermatology, Pediatrics, and Rare Diseases.

We’re looking for a talented and energetic Director ofBiostatistics to join our team! This is a very exciting opportunityto join a dynamic and innovative team and grow with aforward-thinking organization that is changing to course ofmedicine.

Working at Premier Research means being an individual - you willbe recognized for what you do and you will truly have an impact.You will be working in a friendly environment with colleagues whoare genuinely supportive regardless of location or seniority.

Premier Research is on an exciting journey - there is a truebuzz throughout the company, so come and be part of it!

As the Director of Biostatistics, you’ll have the opportunity toserve as a core leader for critical and innovative projects. Youwill oversee and provide strategic guidance for Biostatisticaloperations, project assignments, and the overall activities of acollaborative and stable project team for both a management andtechnical aspect (with particular emphasis on scientific rigor andapplication of ‘current’ statistical methodology). You’ll alsoensure quality deliverables to the sponsor as well as compliancewith project specifications. As the Director, you will also providecoaching guidance and management to the team in addition tooverseeing the technical evolution of the departmental workproduct.

You will have the opportunity to represent the department duringbid meetings, audits, and for statistical advice throughoutclinical projects.

What you’ll be doing:

Supervise, mentor, and motivate reporting team members in tasksand activities that aligns with Premier’s aspiring, empowering andhigh performance culture and assigns work to team

Act as Lead Biostatistician to interact with the study team andthe Sponsor and Project Manager for stand-alone projects,consultancy work, DSMBs and DMCs

Support Business Development by preparing for and attending biddefense meetings, preparing capabilities presentations, andassisting with budget and proposal development.

Direct efforts in Biostatistics project costing estimates andchange order process; provide oversight and reporting of projectprogress and financial health within Biostatistics; track projectrevenue and backlog as well as hours for accurate billing and toforecast hours to complete

Participate in functional and/or corporate initiatives,including committees, special assignments, and act as thedepartmental cross-functional liaison

Develop and implements strategies to actualize goals; developand maintain overall awareness in the field of biostatistics byreading related literature, attending training classes,professional meetings, statistical conferences etc.

Represent Biostatistics as Statistical expert both internallyand externally

Facilitate resolution of project related conflicts withnecessary corrective action and alerts senior management topotential issues

Prepare specifications for CDISC and other analysis datasets

Independently develop statistical analysis plans and SASprograms to generate listings, tables and figures as outlined by astatistical analysis plan and to generate randomization codes

Maintain Biostatistical section of TMF

Perform QC of TLFs, CDISC and other analysis data sets

You’ll need this to be considered:

Advanced degree (MS or PhD) in statistics or closely relatedfield along with 8 years of experience in clinical trials designand analysis using SAS, including 4 years of experience assupervisor/manager

Knowledge of ICH, local regulatory authority drug research anddevelopment regulations along with demonstrated experience ininteractions with regulatory agencies (FDA, EMA, EU memberstates)

Proven experience of advanced SAS programming skills; priorexperience using computerized information systems; proficiency inMicrosoft Office; knowledge of web based communication tools forconferences

Proven to apply clear and consistent performance standards andhandles problems decisively and objectively

Known to build client confidence and achieving high levels ofcustomer satisfaction

Ability to communicate basic statistical concepts to otherscientists and nonscientists

Known for being customer-focused in approach to work andcommunications with the ability to professionally interact withsites, clients, vendors and other functional areas; strong verbaland written communication and negotiation skills

Maintains a positive, results orientated work environment;excellent team player, collaborative and able to build an effectiveteam; Strong people management skills to motivate, enthuse, andlead

Excellent organizational and time-management skills, ableprioritize work to meet deadlines; ability to multitask and workeffectively in a fast-paced environment with changing priorities;accountable, dependable and strong commitment.

You have been redirected to a Premier Research job page

Keywords: Premier Research Group Limited, Atlanta , Director, Biostatistics (US Based), Other , Atlanta, Georgia

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Keywords: Premier Research Group Limited, Atlanta , Director of Biostatistics, Other , Atlanta, Georgia

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