Lead Statistical Programmer- CDI -M/F

<div><div><div><div><div><div><div><h1><span class="emphasis-3"><b><b>Who we are ?</b></b></span></h1><p style="text-align:inherit"></p></div></div></div></div></div></div></div><p style="text-align:left">Pierre Fabre is the 2nd largest dermo-cosmetics laboratory in the world, the 2nd largest private French pharmaceutical group and the market leader in France for products sold over the counter in pharmacies.</p><p style="text-align:inherit"></p><p style="text-align:left">Its portfolio includes several medical franchises and international brands including Pierre Fabre Oncologie, Pierre Fabre Dermatologie, Eau Thermale Avène, Klorane, Ducray, René Furterer, A-Derma, Naturactive, Pierre Fabre Oral Care. </p><p style="text-align:left"><br />Established in the Occitanie region since its creation, and manufacturing over 95% of its products in France, the Group employs some 10,000 people worldwide. Its products are distributed in about 130 countries. 86% of the Pierre Fabre Group is held by the Pierre Fabre Foundation, a <span><span><span><span><span class="WKN2">government-recognized</span></span></span></span></span> public-interest foundation, while a smaller share is owned by its employees via an employee stock ownership plan. </p><p style="text-align:left"><br />In 2019, Ecocert Environment assessed the Group’s corporate social and environmental responsibility approach in accordance with the ISO 26000 sustainable development standard and awarded it the “Excellence” level.</p><p style="text-align:left"><br />Pierre Fabre is recognized as one of the &#34;World&#39;s Best Employers 2021&#34; by Forbes. Our group is ranked in the Top 3 in the cosmetics industry and in the Top 10 in the pharmaceutical industry worldwide. </p><p style="text-align:inherit"></p><p style="text-align:inherit"></p><p style="text-align:inherit"></p><p style="text-align:inherit"></p><h1><span class="emphasis-3"><b><b>Your mission</b></b></span></h1><p style="text-align:inherit"></p><p>We are currently seeking a<b> highly skilled and experienced Lead Statistical Programmer to join our Biometry Department, </b><b><span>part of the Data Science &amp; Biometry Department based in Toulouse (31, Langlade, Oncopole) or Boulogne (92).</span></b></p><p></p><p>This position requires a strong expertise in the application of programming within the context of randomized controlled trials (RCTs).</p><p></p><p>The successful candidate will be agile and adaptable, capable of working in a matrix-organized environment where collaboration across Data Management, Programming, and Statistics is essential. Whilst an excellent track record in Randomized Controlled Trials is a must, the successful candidate will also contribute to Real Worl Evidence (RWE) studies.</p><p></p><p><b><u>Your role within a pioneering company in full expansion:</u></b></p><p></p><h2>Key Responsibilities</h2><ul><li>Participate in the design and execution of RCTs and RWE studies, ensuring high-quality programming support.</li><li>Develop and validate programs for data analysis, reporting, and visualization in accordance with regulatory guidelines and standards (e.g., ICH, EMA, FDA, PMDA).</li><li>Collaborate with statisticians, data managers, and other stakeholders to ensure accurate and efficient data processing and analysis.</li><li>Assist in the selection and evaluation of subcontractors, establishing clear requirements and evaluating proposals.</li><li>Contribute to the preparation of regulatory documents and scientific publications by providing programming support and expertise.</li><li>Follow all industry standards, including ensuring that all biometry-related documentation is included in the electronic Trial Master File (eTMF).</li></ul><p></p><p>This position is compatible with teleworking up to 2 days a week according to company rules.</p><p>We offer an attractive remuneration/benefits package: Incentives, profit-sharing, Pierre Fabre shareholding with matching contribution, health and provident insurance, 16 days of holidays (RTT) in addition to 25 days of personal holidays, public transport participation, very attractive CE...</p><p style="text-align:inherit"></p><p style="text-align:inherit"></p><div><div><div><div><div><div><div><h1></h1><h1><span class="emphasis-3"><b><b>Who you are ?</b></b></span></h1><div><div><div><div><div><div><p style="text-align:inherit"></p><div><h1></h1></div></div></div></div></div></div></div></div></div></div></div></div></div></div><h2><b><u>Your skills at the service of innovative projects:</u></b></h2><ul><li>Advanced degree in Statistics (Master&#39;s Degree, ENSAI, ISUP, or PhD) or a related field.</li><li>A<b> minimum of 6 years of experience in the pharmaceutical industry or a Contract Research Organization (CRO), with hands-on experience in RCTs and RWE studies.</b></li><li>Programming in CDISC (SDTM &amp; ADaM) and writing associated documentation (Define, ADRG...)</li></ul><p></p><h1>Mandatory Skills</h1><ul><li>Proficiency in SAS and R programming languages</li><li>Extensive experience in Randomized Controlled Trials (RCTs)</li><li>Strong knowledge in CDISC (SDTM &amp; ADaM) and associated documents (Define, ADRG, ...)</li><li>Strong knowledge of international scientific and regulatory recommendations (e.g., ICH, EMA, FDA)</li><li>Ability to collaborate effectively with statisticians, data managers, and other stakeholders</li><li>Excellent written and verbal communication skills in English</li><li>Excellent communication and cooperation skills, with a rigorous and pragmatic approach.</li><li>Creativity, proactivity, rigor, autonomy, and collaborative spirit.</li><li>Strong ability to manage multiple studies simultaneously and maintain organization.<br /> </li></ul><h2>Optional Skills</h2><ul><li>Experience with other statistical programming languages (e.g., Python, SQL)</li><li>Knowledge of Real-World Evidence (RWE) studies</li><li>Experience in EMA, FDA or PMDA submissions</li><li>Experience in oncology clinical trials </li></ul><p></p><h1>Application Process</h1><p>Interested candidates should submit their resume and a cover letter detailing their experience and qualifications for this position.</p><p></p><p>The hiring manager is <b>Romain Raymond</b>, Programming &amp; Biometry Platform Manager.</p><p>The Head of the Biometry Department is Guillaume Desachy.</p><p></p><p>We look forward to welcoming a new member to our dedicated and innovative team at Pierre Fabre.</p><p style="text-align:inherit"></p><p style="text-align:inherit"></p><p style="text-align:inherit"></p><p style="text-align:left"><i>We are convinced that diversity is a source of fulfillment, social balance and complementarity for our employees, which is why our offers are open to all, without restriction.</i></p>