Senior Biostatistician

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:

The position provides oversight on clinical studies, provides statistical support on in-house clinical studies and projects including the development of statistical output and report that are of high quality; participate in development of strategies related to global biostatistics;

Specific Responsibilities:

• Provide oversight of statistical tasks on studies that are outsourced to partners

• Manage the development of statistical output and documents with programming team

• Provide (or manage others who provide) statistical support on clinical studies, including representing the Biostats group on clinical study teams, providing input on the development of study protocols, statistical analysis plans with programming specifications, and other clinical documents

• May participate in agency meeting or corporate audits

• May participate in development of procedures, work instructions, SOPs

• Must ensure compliance of clinical documents with regulatory requirements and guidelines and guidelines and Servier procedures (as applicable)

• Develop knowledge of therapeutic areas as assigned

• Prepare responses to questions from regulatory agencies and provide input on publications

Skills and Education:

The position must demonstrate

• Excellent verbal and written communication skills

• Experience in the analytical evaluation of analysis of clinical study data

• Exceptional organizational skills and attention to details

• Project management skills and familiarity with GCP and ICH guidelines

The position must be able to

• Manage multiple projects with competing priorities

• Maintain expertise in statistical analysis methods

• Show competency in leadership and mentoring other team members

• Communicate statistical issues across multi-disciplinary team

• Apply internal standards (including CDISC) and regulatory requirements/guidance

• Work in a team environment

Education and/or Experience:

Master’s degree in statistics or related area is required, Ph.D. degree is preferred with several years of experience in the design and analysis of clinical studies in accordance with GCP. Experience in oncology trial preferred.

Travel and Location

• Some domestic and international travel may be required

• This is a hybrid position based in Boston, MA approximately 2 days 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.