Associate Director, Statistical Programming

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.

Responsibilities:

• Develop statistical programming on study or project level either by hands-on programming or oversight of outsourced programming deliverables.
• Ensure statistical programming processes and deliverables are aligned with regulatory requirements.
• Act as technical lead and project manager for multiple studies by managing all aspects of study deliverables related to statistical and clinical programming.
• Independently implement routine and non-standard analysis algorithms for assigned projects or studies.
• Collaborate with statisticians, local and Clinical Research Organization (CRO) programmers to define and implement analysis requirements and perform sponsor oversight regarding data and analysis.
• Ensure statistical programming systems, processes and deliverables are aligned with the relevant regulatory requirements.

Qualifications:

• Must have a Master's in Mathematics, Applied Mathematics, Statistics, Biostatistics, Clinical Research, Computer Science, or Engineering.
• Must have eight years of experience as a statistical programmer analyzing clinical trial data in biotech or pharmaceutical companies, or CRO providing programming services to biotech or pharmaceutical companies.
• Must have experience with:
  • United States Food and Drug Administration (FDA), European Union's European Medicines Agency (EMA), or Japan's Pharmaceuticals and Medical Devices Agency (PMDA) submissions.
  • Clinical Data Interchange Standards Consortium (CDISC) Study Data Tabulation Model (SDTM) and Analysis Data Model (ADaM) guidelines.
• Experience may be gained concurrently.

Additional Information:

• Position eligible for telecommuting from any location within the United States.
• Apply to Servier Bio-Innovation LLC  at: jobs.servier.com

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.

Salary Range

The salary range for this role is Pay Range: $129,771 - $176,401. An employee’s pay position within the salary range will be based on several factors including, but not limited to, relevant education, qualifications, certifications, experience, skills, geographic location, performance, and business or organizational needs. We may ultimately pay more or less than the posted range, and the range may be modified in the future. Employees in this position are also eligible for Short-Term and Long-Term incentive programs. Servier also offers a competitive and comprehensive benefits package that includes benefits such as medical, dental, vision, flexible time off (Servier provides unlimited sick time and flex time, and does not accrue time off), 401(k), life and disability insurance, recognition programs among other great benefits (all benefits are subject to eligibility requirements).  For more information on our benefits, please visit this link.