Associate Director, Biostatistics Project Lead

2 months ago

Boston, United States Servier Full time

About Servier

With commercial stage products and a promising pipeline, we are a US-based affiliate of Servier Group, a unique global organization headquartered in France. Operating in more than 150 countries and governed by a non-profit foundation, we have multiple medicines approved in oncology, & other disease states globally. Additionally, we have accelerated our investments with an ambition to further establish ourselves as innovators in the Oncology space. Over half of our research and development efforts are specifically focused on delivering significant advances in targeted therapies to treat patient communities with unmet needs. At Servier, you will join a highly skilled team dedicated to bringing the promise of tomorrow to the patients we serve.

SUMMARY OF ROLE:

For one or more products within related Therapeutic area, responsible for all statistical aspects of clinical development plan, individual studies and submissions, including quality, relevance to regulatory perspective and scientific validity, in collaboration with clinical and regulatory leads. This position will focus on late phase oncology projects.

Area of responsibility Provides input into product development strategy by suggesting innovative designs and decision making tools. Selects appropriate statistical methods for design of clinical trials and the analysis of clinical study data; Reviews protocols. Oversees execution of statistical analyses, reviews statistical outputs and guarantees results interpretation. Reviews and approves the statistical methods and results sections for clinical study reports (CSR). Reviews regulatory documents such as CSRs, as well as integrated reports and summary documents. Responsible for interacting with regulatory authority personnel on clinical trial statistical issues in the design, analysis of clinical trials, design of other study types, and data presentations. Provides guidance to the clinical and regulatory teams regarding conclusions and inferences from the data package. Ensure statistical representation at regulatory or other external meetings. Completed data package relevant for submission or making key decisions. Oversees statistical support to multiple project teams. Works independently, or with other statistical departmental members or consultants, to develop effective statistical approaches applicable to project. Area of responsibility Consults with the Medical Writer and Physician on the interpretation of clinical results. Contributes to the publication plan. Reviews abstracts, posters, and manuscripts to support Medical Affairs. Area of responsibility Leads or contributes to departmental process improvement initiatives and development/revision of SOPs. Maintain awareness of industry standards, regulatory requirements, and departmental guidelines and SOP. Within area of control, update procedures or practices as needed to remain in compliance. Procedures and practices meet industry standards and are consistent with internal SOP. Contributes to the establishment and maintenance of common formats and templates for key Biostatistics documentation (e.g., statistical section of protocol, standard CRF pages, Statistical Analysis Plans, Tables, Figures and Listings). Plan and track project activities and timelines across projects. Provide justification for planned resource needs. Seek to optimize resource utilization and capacity. Accurate plans, well-managed projects, capacity to apply extra resources in urgent situation. Other duties as required or directed by the Manager or Functional Management

Skills and Education:

M.S. in Biostatistics or closely related field Ph.D. in Biostatistics or closely related field is strongly preferred. Generally has 8+ years of relevant pharmaceutical experience, including experience in Oncology and interactions with regulatory bodies Broad knowledge and superior understanding of advanced statistical concepts and techniques Innovatively applies technical principles, theories, and concepts to pharmaceutical clinical development and life cycle management Ability to determine appropriate designs and analyses for clinical trials. Strong background and working knowledge of statistical methods that apply to all phases of clinical trials and other study designs. Must have a working knowledge of statistical analysis plans including the report outline, mockup tables, graphs and data listing shells and appendices. Must have a working knowledge of all appropriate relevant regulatory guidance documents (e.g. ICH, FDA and EMEA). Direct regulatory filing experience. Ability to respond to regulator’s inquiries for products undergoing registration and approved products. Proficiency in SAS is strongly preferred. Ability to take appropriate action in all dealings with CRO partners to ensure that best practices are followed. Demonstrated ability to evaluate the business impact of decisions and remains committed to following through on agreed upon decisions yet remains flexible should priorities change (judgment and decision making)

Other Relevant Information:

Some domestic and international travel required Boston, MA Based. Approximately 2 days/week onsite

Servier’s Commitment

Servier is committed to modeling diversity, equity, and inclusion within the industry. We are dedicated to fostering an environment that maintains equitable treatment for all and we welcome applicants who are passionate, committed, and innovative individuals. We encourage candidates to apply to our open roles as we are always willing to consider experiences and skills beyond what is listed in the job description.

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.

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