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Job Details

Principal Biostatistician

Company: CROMSOURCE
Location: United States
Reference: HQ00000973
Closing Date: 15 Sep 17
Type: Permanent
Salary (£): On Application
Benefits: Excellent and Comprehensive Benefits – see below

Job Summary:

TalentSource Life Sciences is currently searching for an experienced Principal Biostatistician to join one of our biotechnology partner companies in Raleigh. This is a permanent position, which will be primarily office based with some flexibility to work from home.   The successful candidate will be working on studies dedicated to one client.   TalentSource is the division of CROMSOURCE dedicated to flexible staffing solutions.

Requirements:

TalentSource Life Sciences is currently searching for an experienced Principal Biostatistician to join one of our biotechnology partner companies in Raleigh. This is a permanent position, which will be primarily office based with some flexibility to work from home.

The successful candidate will be working on studies dedicated to one client.

TalentSource is the division of CROMSOURCE dedicated to flexible staffing solutions. Through us, you will have the opportunity to be integrated into a sponsor-led team, whilst having the continuous support from your TalentSource Line Manager who will work closely with you to support your professional development and growth.

Key Accountabilities:

The Principal Biostatistician has a broad technical leadership responsibility and expertise in the relevant therapeutic area, key indication or compound. The individual will have experience in providing statistical support for the life cycle of a development compound (from phase I/II through phase IV and post approval activities). They will serve as a statistical consultant for other biostatisticians, providing strategic statistical input on the target patient value profile, clinical development and regulatory submission plans for the cross-functional team. The incumbent will represent the sponsor in interactions (both oral and written) with regulatory agencies. The individual is responsible for ensuring common line-of-sight between the biostatistician study lead, other biostatisticians and statistical programmers, as well as external partners, of all deliverables and timeline expectations across the therapeutic area, key indication or compound under their scope of influence.

Job specific tasks and responsibilities:

· Serves as statistical expert in the therapeutic area, key indication or compound under their purview and provides strategic input to the target patient value profile, clinical development plan, regulatory submission plan and the life cycle of a development compound, by suggesting innovative statistical methods that will help accelerate the development process or market access.

· For the therapy area and/or indication, coordinates the work of the Biostatistician Study Lead, other Biostatisticians and Statistical Programmers assigned to the Mission, to ensure high quality of statistical deliverables in close collaboration with external vendor partners.

· Act as the Biostatistics Lead for scientific evaluation of in-licensing opportunities.

· Act as a technical resource for less experienced biostatisticians.

· Adheres to the company SOPs and processes.

· Frames questions and problems to incorporate multiple perspectives and provide a path to making sound decisions.

· Communicates complex issues in nontechnical language by using visuals, simulations and other illustrative techniques.

· Uses technical expertise to pro-actively influence business decisions.

· Identify and facilitate risk-mitigation combining quantitative sciences and disease area/competitive landscape knowledge

· Such other responsibilities and projects that the Company may assign.

· Develops, maintains and ensures standardization across the clinical studies within the clinical program. Adheres to the global standards.

· Manages and coordinates the biostatistical deliverables required for the NDA/MAA submission for the clinical program and ensures the deliverables are completed accurately and in accordance with timelines. If this is delegated to an external partner biostatistician, reviews the biostatistical deliverables by the assigned vendor.

· Provides input for pooling strategies for submissions and IND updates, and provides statistical input into the Investigator Brochure.

· Reviews sections of NDA/MAA submissions (including ISE, ISS, summary of clinical efficacy, summary of clinical safety, clinical overview, and any other specific sections of importance [e.g., cardiac safety report, abuse liability report, suicidality report, and risk management plan]) and attends and contributes to all related roundtable discussions.

· Works with submission teams to ensure proper responses to statistical related questions from regulatory authorities or Health Technology Assessment (HTA) bodies are delivered in a timely manner.

· Global travel may be required

· Other duties as assigned by company

Education, Qualifications & Experience:

· PhD (preferred) or Master's degree in a relevant field

· Extensive experience in biostatistics within the biotechnology and/or pharmaceutical industry (including CROs) with a proven successful track record in pharmaceutical development and demonstrated leadership in clinical development programs.

Skills & Knowledge:

· Understands the implications of the pharmacokinetic profile of a drug on the design of pharmacodynamics and Phase I-III studies, or vice versa.

· Familiarity with later Phase studies, e.g., non-interventional, retrospective studies, or experience working with Health Technology Assessment (HTA) bodies.

· Able to coordinate a team of biostatisticians and statistical programmers in the execution of a clinical program to support therapy area biostatistical deliverables.

· Sound knowledge of the ICH guidelines. Understanding of the regulatory requirements from EU, US and Japanese health authorities, and of the submission process in each.

· Experience with NDA/MAA submissions.

· Good knowledge of advanced statistical methodology.

· Established experience in contributing to global scientific improvement/change initiatives

· Good project management skills.

· Good knowledge in SAS and/or R programming.

· Good knowledge in visualization and simulation techniques.

· Excellent written and verbal communication skills in English.

· Able to work under pressure and without close supervision.

· Able to explain advanced statistics in a non-technical manner to non-statisticians.

· Able to adapt to change.

· Able to multi-task and anticipate future statistical needs and the maturity to work in a highly independent, self-motivated manner.

· Able to communicate clear, precise, accurate instructions and to interact effectively in a consulting environment.

· Able to pro-actively propose and defend alternative and often innovative study designs and statistical methods.

· Is a keen learner. Shows an active participation toward learning new statistical concepts, and the relevant aspects of the disease area of the related clinical programs.

· Provides examples of being a self-starter who is self-directed and self-motivated without putting self-first.

· Able to adapt to working in a multicultural global environment.

· Able to adapt to changing priorities and deliver results in a timely manner.

If you have the experience and are interested in discussing the role for this position, please contact Meredith Wells, Meredith.Wells@cromsource.com.

Why TalentSource Life Sciences/Cromsource?

Cromsource is a family-owned, high quality ISO-certified international provider of outsourced services to the pharmaceutical, biotechnology and medical device industries. Since 1994, we have been supporting our clients with outstanding clinical research and staffing solutions services. TalentSource Life Sciences is a fully dedicated flexible resourcing unit within CROMSOURCE and the successful growth has been achieved by putting high quality and client focus at the heart of everything we do.

Our employees are the most valuable company asset and we value resources and ensure they work in a friendly, family environment and develop their skills and talents. Human Resources is the fulcrum around which all activities are built and close management and training is the core instrument to develop and maintain highly-qualified personnel. The continuous training keeps the resources qualified in terms of competence and expertise and gives to all personnel clear tools to manage both internal and client processes with the same methodology.

Our approach is to equally value our clients and our own people. We know that we are not simply providing 'staff' or 'resources'. We are providing expert people. Highly talented, well trained, motivated people who make a positive difference to the work of our clients every day. Together we help our clients succeed in their work developing medicines and medical devices for patients around the world. Our large management team consists of a people with an extended experience within pharma and a high level of market knowledge. We our open, friendly and approachable and aim to support you through the recruitment process every step of the way.

As this position is client-facing, the successful candidates must be confident and be able to drive the role and themselves and to work autonomously in close liaison with a line manager at TalentSource, who will provide you with mentoring and guidance.

To ensure the success of our clients, our team of international professionals is focused on continuous improvement. We invest in our employees by providing the coaching and training necessary to deliver high quality services for our clients.

Every day we strive to create an environment in which all employees can contribute to their full potential and at the same time allow the company to develop and grow with them. With CROMSOURCE you will be able to participate in exciting projects and achieve your professional goals.

Keywords: Biostatistics, Biostatistician, Statistics, Biostats, SAS, Contract Research Organisation, CRO, Pharmaceuticals, Pharma, Biotechnology, Biotech, Biopharmaceuticals, Biopharma, Outsourced

Biostatistician, Senior Biostatistician, Permanent

Apply for this job: Principal Biostatistician

Contact Information:

Address:  UK Office
CROMSOURCE Suite 3 Lomond Court Castle Business Park Stirling United Kingdom
FK9 4TU
Scotland
Tel:  +44 (0) 1786 468990
Website:  Visit Our Web Site

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