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Director, Biostatistics

Employer
GSK
Location
Warren, New Jersey
Salary
Competitive
Closing date
Sep 23, 2021

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‘Be You' at GSK At GSK, we're a company with a purpose to help people do more, feel better and live longer. We realise that our purpose starts with us. When we feel at our best, we perform at our best. Therefore, we want all applicants to be able to perform their best throughout the recruitment process. We will be delighted to hear from talented individuals that align to our values. These are at the heart of everything we do and include: Patient focus, Transparency, Respect, Integrity along with Courage, Accountability, Development, and Teamwork. When you set out on your adventure at GSK, we make a deal. You commit to living our values and expectations and performing against our Innovation, Performance and Trust priorities. In return, GSK commits to providing the right environment for you to thrive. Together, we build an environment where we can all thrive and focus on what matters most to each of us. As a , we empower you to be yourself, share ideas and work collaboratively In this role you will Provide scientific and technical statistical leadership on studies from non-clinical development planning through to publication, where appropriate Interacts with senior internal and external stakeholders on statistical issues Provides technical leadership and expertise to guide Statisticians when challenges arise in clinical studies and liaise with other business units and/or statistical experts for those situations Work as a Study Statistician on more complex projects, including submission projects and as required partake in escalation/troubleshooting activities Co-ordinates and leads all Biostatistics and Data Management (BDM) activities for projects, where appropriate Leads functional and cross-functional process improvement initiatives Providing Third Party oversight of strategic and tactical partners as related to area of responsibility Provide expert statistical knowledge and leadership for activities to support the business outside of clinical studies, such as due diligence, complaint/challenge and training Coaching and mentoring junior staff across BDM Stay current on methodological/technical advances in relevant field This role provides expert statistical input and leadership in relation to clinical trials, real-world evidence and other statistical work executed by the Consumer Healthcare division across multiple categories, including detailed regulatory interactions. This role is accountable for the successful execution of the delegated projects and will involve leadership of oversight of Third Party Vendors. This role may deputize for Head of BDM on reviews/approvals and other interactions. Closing Date for Applications: 30th September 2021 (COB) Please take a copy of the Job Description, as this will not be available post closure of the advert. When applying for this role, please use the ‘cover letter' of the online application or your CV to describe how you meet the competencies for this role, as outlined in the job requirements above. The information that you have provided in your cover letter and CV will be used to assess your application. During the course of your application you will be requested to complete voluntary information which will be used in monitoring the effectiveness of our equality and diversity policies. Your information will be treated as confidential and will not be used in any part of the selection process. If you require a reasonable adjustment to the application / selection process to enable you to demonstrate your ability to perform the job requirements, please contact 0808 234 4391. This will help us to understand any modifications we may need to make to support you throughout our selection process. *LI-GSK Why you? Qualifications & Skills: We are looking for professionals with these required skills to achieve our goals: Masters degree (or equivalent) in statistics or related field Has experience in leading the statistical activities in multiple therapeutic areas and multiple projects Experience in leading regulatory submissions interactions Experience setting up third party vendors and providing oversight for statistical activities Proven influencing skills, which are applied effectively at all levels of the organisation and across functional boundaries, especially at the senior management level Understands the internal organization at a higher level, represents the BDM Department to those outside the department - higher level management, regulatory agencies, other departments Knowledge of Industry standards such as ICH and country-specific regulatory requirements Preferred Qualifications & Skills: If you have the following characteristics, it would be a plus: Doctorate level degree (or equivalent) in Statistics or related field Strong teamwork Excels in all the skills and abilities required of statisticians Possesses excellent communication skills and judgment abilities Ability to oversee third parties including the work and personnel, oversee relevant statistical work internally Why GSK? GSK is a place where outstanding people do amazing things. As a science-led global healthcare company, we exist to help people do more, feel better, live longer. This special purpose - along with our goal of being one of the world's most innovative, best performing and trusted healthcare companies - helps us attract some of the best and brightest minds in the world. We take pride in providing access to all and continually focus on our opportunity and obligation to do more to improve inclusion and diversity: for our people inside GSK; in the way we do business; and in the communities where we operate.  We want our company to be a place where diversity of people and thought is valued everywhere and where we're all able to be ourselves and feel a sense of belonging. An inclusive organization where we all feel valued, engaged and supported, knowing that our work makes an important contribution to our mission. Reinforced by our clear values and expectations, it is part of our DNA. Together we achieve extraordinary things for our patients and consumers, who rely on us each and every day. If you require an accommodation or other assistance to apply for a job at GSK, please contact the GSK Service Centre at 1-877-694-7547 (US Toll Free) or +1 801 567 5155 (outside US). GSK is an Equal Opportunity Employer and, in the US, we adhere to Affirmative Action principles. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class. Important notice to Employment businesses/ Agencies GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site. Please note that if you are a US Licensed Healthcare Professional or Healthcare Professional as defined by the laws of the state issuing your license, GSK may be required to capture and report expenses GSK incurs, on your behalf, in the event you are afforded an interview for employment. This capture of applicable transfers of value is necessary to ensure GSK's compliance to all federal and state US Transparency requirements. For more information, please visit GSK's Transparency Reporting For the Record site.

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