Real Challenge, Real Impact. Real Rewards.
Do you have a passion problem solving? Are you excited about crafting trials and implementing a statistical approach that maximizes the chance of reaching your objective? Can you effectively communicate and influence leadership and external stakeholders on what you're doing, why you're doing it, and how this meets their goals? How would you like to be part of a company that is on the forefront of changing the future of an entire industry for the better? If you answered yes, then come join Altria!
Our companies have a long history of leading the industry and the future of our industry is about innovation, harm reduction and informed consumer choice. That’s why Altria is investing in a portfolio of new products that satisfy changing preferences and have the potential for lower risk. Through product innovations, we strive to give consumers the choices they want today — and develop new technologies for tomorrow.
This is where you come in. Altria has an exciting opportunity for a highly qualified Senior Biostatistician to join our Regulatory Affairs department, located in our state of the art Center for Research and Technology facility in downtown Richmond, VA. You will provide statistical support and lead clinical study statistics and associated FDA interactions for tobacco product submissions. Working both independently and with scientists, engineers and other statisticians, you will provide advanced statistical and analytical expertise in regulated environments. Part of your role will be to work face to face with the FDA, and communicate the statisical analysis of clinical study data, and demonstrate how they meet FDA objectives.
Provide subject matter expertise to clinical study designs, statistical analysis and data outputs for clinical trials. Lead collaboratively within a framework of study teams.
Lead study statistical design, sample size calculations, development of statistical analysis plans, data review, and query management.
Lead SAS programmers and validation of STDM and ADAM datasets.
Optimize clinical systems and processes as they relate to clinical statistics.
Develop and execute statistical analysis plans in collaboration with CRO statisticians based on input from cross-functional study team.
Participate with Operations in the selection and management of statistics and data management suppliers (CROs) to include leading project timelines.
Strategically allocate resources to allow for efficient and smooth interaction with study team on statistics and data management related tasks.
Collaborate with Regulatory Affairs and other health scientists to interact and communicate with FDA regarding regulatory submissions.
Apply innovative thinking in design and analysis of clinical studies by bringing creative ideas for problem solving. Interact with all levels of management.
Validated expertise in clinical study design and analysis, specialize in statistical methods used to support analytical and clinical validation of products for regulatory submissions.
Build relationships with external authorities in statistics that impacts Altria's companies. Interact within and across departments in developing and leading cross-functional projects.
Demonstrate working knowledge of leadership responsibilities and behaviors. Ensure effective application of values in action at a personal/work group/department level.
Excellent writing skills and ability to effectively communicate with all partners. Frequently present to internal scientists including senior management.
Craft infra-structure to improve processes within department and ALCS; and Identify future technical talent needs, and help assess/develop talent within department.
Ability to travel 20% of the time.
Master’s degree required. Ph.D. or related specialized training in statistics or comparable quantitative sciences preferred.
Significant experience in Bio-Tech, medical device or pharmaceutical industry with hands-on experience running the statistical aspects of clinical trials. 10+ years preferred.
Some experience necessary acting as sponsor subject matter expert presenting the analysis of study data to the FDA.
Experience with leading and working with 3rd party vendors in clinical studies.
Strong knowledge of FDA regulations, ICH guidelines, GCP practices.
Established researcher in the field of statistics.
Knowledge of meta-analysis techniques.
Leadership experience in execution of all statistical aspects of clinical trials - from planning phase to completion phase.
Strong project planning and management skills to ensure goals to be met under tight timelines, as well as an ability to contribute creative and practical solutions to problems.
Company Overview:Altria Group is a FORTUNE 200 company that leads the premier tobacco companies in the United States. Headquartered in Richmond, Virginia, Altria Group holds diversified positions across tobacco, alcohol, and cannabis. Our tobacco companies include some of the most enduring names in American business: Philip Morris USA, U.S. Smokeless Tobacco Company, John Middleton, and Nat Sherman. We have 35 percent ownership of JUUL Labs, Inc., the nation’s leading e-vapor company. And we have an 80% interest in Helix Innovations, which manufactures and markets on!, an oral tobacco-derived nicotine pouch product. We complement our total tobacco business with our ownership of Ste. Michelle Wine Estates and our significant equity investment in Anheuser-Busch InBev, the world's largest brewer. Altria’s significant stake in Cronos Group, a leading global cannabinoid company, represents an exciting new global growth opportunity. At Altria, we recognize that our people are the reason we achieve our business goals. It’s only through diverse perspectives and insights that we will be able to take on the important challenges we will face to dramatically transform our business – and our industry. The work opportunities and experiences, combined with training, development, and advancement programs, allow our employees to achieve their full potential and deliver superior business results. We have the opportunity to make more progress on harm reduction in the next 10 years than we have in the past 50 years. Join us as we work together to shape a better future for adult tobacco consumers, our employees, and our shareholders. Each Altria company is an equal opportunity employer.