Lead Biostatistician, Early and Exploratory Clinical Statistics
Rockville , Maryland
October 19, 2017
Basic qualifications:
•Masters in statistics, mathematics, epidemiolog
•At least 5-year experience in pharmaceutical industry
• Has been previously responsible for studies with different designs (dose range, superiority/non inferiority, futility rule,..)
•Experience in SAS software and sample size computation for standard designs

Preferred qualifications:
•PhD in statistics, mathematics, epidemiology
•Ability to work in multidisciplinary team (e.g., give guidance to non-statisticians, provide feedback, engage), some being remotely located
•Good oral and written communication in English including ability to explain difficult issues and situations clearly and ensures meaning is understood

•Provide strategic & statistical input in defining Clinical Development Plans
•Within the context of biologicals product development, defines, recommends, analyses and interprets the statistical part of projects in order to guarantee the statistical reliability of the conducted studies and dossiers and to allow the world-wide registration in compliance with the clinical development plan, good practices (GCP, GSP, ICH, ...).
•Close collaboration with R&D for the validation of assays, Safety for the safety review of our products and with Regulatory for the submission of new products.
•Spreads good statistical practices.
•Drive (search and/or develop) and Implement new statistical approaches, innovation in the business

Key Responsibilities
•Accountable for statistical expertise in bringing vaccines from early/late development to registration:
•Leader in providing innovative approaches to better design and analyse our trials and speed time-to-market
•Provide strong arguments to support upper management decisions. Defend independently statistical positions in external meetings (IND, advisory board) and towards Health Authorities
•Provide active statistical expertise to other department for solving emerging questions requiring specific and complex statistical expertise.
•Coordinate statistical activities related to the Franchise. Responsible for the statistical quality & delivery within the Franchise.
•Ensure consistency across the different product developments in the Franchise and across Franchise.
•Communicate highly technical issues to non-statisticians at senior management level
•Create external network to develop and bring adequate statistical approaches in clinical developments, lead or contributor author on statistical/product development papers, develop collaboration with external experts to efficiently meet the Franchise objectives.
•Lead the deployment (development, build acceptance through external credits from experts or Authorities, implementation) of new methodologies within GSK Bio. May lead the development of new processes/tools.
•Influences new or reviewed Authorities guidelines in statistical approaches for products development.
•Pro-actively support the development of biostatisticians within the organization


Contact information:

You may apply for this position online by selecting the Apply now button.
If you require an accommodation or other assistance to apply for a job at GSK, please contact the GSK HR Service Centre at 1-877-694-7547 (US Toll Free) or +1 801 567 5155 (outside US).

GSK is an Equal Opportunity/Affirmative Action Employer. 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.

A little about us:
We are a science-led global healthcare company on a mission to help people to do more, feel better and live longer.

Know someone who would be interested in this job? Share it with your network.