Cytel

Role Description We are seeking a Senior/Principal level biostatistician to fill a post-submission and RWE role with a major client. This individual should be an experienced/veteran statistician in the healthcare industry and looking to take on a leadership role in such an environment. - Join our FSP department and work for one of the top pharmaceutical companies. - Lead post submission evidence generation using CDISC datasets, Claims, and raw biological data. - Bring mature computational, operational and production experience. Qualifications - Experienced/veteran statistician in the healthcare industry. - Leadership experience in a biostatistics role. Requirements - Expertise in post-submission and RWE processes. - Proficient in handling CDISC datasets, Claims, and raw biological data. Benefits - Significant professional growth opportunities. - Collaborative work environment focused on advancing drug development.

Title: Associate Counsel - Software Licensing & Commercial Contracts Location: US Job Description: (Remote - EST preferred) We are seeking an experienced attorney to support our growing technology business by providing legal guidance on software licensing, SaaS agreements, commercial transactions, and related corporate matters. This individual will partner closely with the commercial sales team, the software products team, finance, proposals, information security/privacy, and executive leadership to negotiate complex agreements, mitigate risk, and support business growth while ensuring legal and regulatory compliance. Responsibilities Commercial Contracting & Software Licensing • Draft, review, negotiate, and manage a wide range of commercial agreements, including: o Software License Agreements o SaaS and Subscription Agreements o Master Services Agreements (MSAs) o Statements of Work (SOWs) o Data Processing Agreements (DPAs) o Non-Disclosure Agreements (NDAs) o Vendor and Procurement Agreements o Professional Services Agreements o Partnership and Reseller Agreements • Advise business stakeholders on contract interpretation, obligations, and risk mitigation strategies. • Support negotiations with customers, strategic partners, and third-party service providers. Legal Risk & Compliance • Identify and assess legal, regulatory, financial, and operational risks associated with commercial transactions. • Provide guidance regarding intellectual property, software licensing models, open-source software usage, and data privacy requirements. • Advise on compliance with applicable laws and regulations, including privacy and cybersecurity requirements. • Develop and maintain contract templates, playbooks, and negotiation guidelines. Cross-Functional Partnership • Collaborate with Sales, Product Management, Engineering, Information Security, and Finance teams to facilitate efficient deal execution. • Provide practical legal advice that balances business objectives with risk management. • Assist in resolving contractual disputes and escalations. Corporate Legal Support • Support internal legal initiatives. • Support outside counsel relationships when necessary. Qualifications - Juris Doctor (JD) from an accredited law school. - Active membership in at least one U.S. state bar. - 4+ years of legal experience, including significant experience negotiating technology and software licensing agreements. - Strong knowledge of: - SaaS and software licensing models - Intellectual property law - Commercial contract negotiation - Data privacy and information security provisions - Experience supporting technology, software, SaaS, or software-enabled services organizations. Preferred Qualifications - Experience in-house at a software, SaaS, cloud, cybersecurity, or technology company. - Familiarity with GDPR, CCPA, and other privacy regulations. - Knowledge of AI, cloud computing, cybersecurity, and emerging technology legal issues. - Experience managing high-volume commercial contract portfolios. Key Competencies - Exceptional contract drafting and negotiation skills. - Strong business judgment and risk assessment capabilities. - Ability to translate complex legal concepts into practical business guidance. - Excellent communication and stakeholder management skills. - Ability to manage multiple priorities in a fast-paced environment. - Strong analytical, organizational, and problem-solving abilities. Preferred Experience - In-house technology company experience. Work Environment - Hybrid or Remote (depending on location) - Ability to support stakeholders across multiple time zones. Reports To: Senior Corporate Counsel Experience Level: Mid-Level (4–6+ years) Employment Type: Full-Time, Exempt** Why Cytel? Cytel is a Global CRO providing ground-breaking biostatistical software and services to large pharma and emerging Biotech clients globally. With our patients at the center of all that we do, we help to accelerate the development of drugs and devices that save lives and improve quality of life. At Cytel, our focus is to provide you with a comprehensive and competitive total reward package. In addition, our world class employee benefits, supportive policies and wellbeing initiatives are tailored to support you and your family at all stages of your career - both now, and into the future. Cytel Inc. is an Equal Employment / Affirmative Action Employer. Applicants are considered for all positions without regard to race, color, religion, sex, national origin, age, veteran status, disability, sexual orientation, gender identity or expression, or any other characteristics protected by law. Job Info - Job Identification1532 - Job CategoryLegal - Locations United States

Role Description Our commitment to developing our staff is only surpassed by our commitment to advancing treatment options available to patients. At Cytel, we work hard to create successful careers with significant professional growth for our employees and as a result work hard to make Cytel successful. Cytel is a place where talent, experience, and integrity come together to advance the state of clinical development. As the world’s leading data-science CRO and pioneers in adaptive trial design, Cytel leverages the power of data to inform clinical strategy at every stage of drug development. From innovative trial design, end-to-end biometrics to real-world evidence, value and access, we strive to shorten the drug development cycle and increase the probability of success, delivering better patient outcomes through our innovative analytical methods. Qualifications - Strong analytical skills - Experience in clinical development - Proficiency in data science methodologies Requirements - Relevant degree in a related field - Minimum of 3 years of experience in a similar role - Excellent communication skills Benefits - Competitive salary - Health and wellness programs - Opportunities for professional development

Role Description We are seeking a Vice President & Clinical Executive Consultant (CEC) to join our Strategic Consulting Team, whose mission is to deliver quantitative thought leadership across design, statistical methods, and decision-making during therapeutic product development. - Expand Cytel’s reputation for innovation and thought leadership by guiding strategic engagements for pharmaceutical, biotech, and medical device clients. - Build and maintain enduring client relationships in collaboration with Cytel’s business development teams and cross-functional colleagues. - Develop and demonstrate expertise in clinical trial design, statistical methodology, and strategic clinical development planning. - Ensure Cytel remains at the forefront of industry innovation and enhance visibility and recognition across the global clinical development landscape. - Design and execute Phase I–IV clinical trials for novel therapeutics. - Provide strategic consulting on clinical, safety/pharmacovigilance, regulatory, and market access pathways to accelerate patient access to new health technologies. Qualifications - Deep and broad experience in designing and executing Phase I–IV clinical trials. - Expertise in related quantitative domains such as adaptive designs, clinical pharmacology, data science, or model-informed drug development. Company Description

Sponsor-dedicated: Working fully embedded within one of our pharmaceutical clients, with the support of Cytel right behind you, you'll be at the heart of our client's innovation. As a Senior Statistical Programmer you will be dedicated to one of our global pharmaceutical clients; a company that is driving the next generation of patient treatment, where individuals are empowered to work with autonomy and ownership. This is an exciting time to be a part of this new program. Position Overview: As a Senior Statistical Programmer, you will leverage your advanced SAS programming skills and proficiency in CDISC standards (SDTM & ADaM) to support or lead one or more Phase I-IV clinical trials. This role can be performed as fully remote. Our values - We believe in applying scientific rigor to reveal the full promise inherent in data. - We nurture intellectual curiosity and encourage everyone to approach new challenges with enthusiasm and the desire for discovery. - We believe in collaboration and invite a diversity of perspectives, drawing on a variety of talents to create a wealth of possibilities. - We prize innovation and seek intelligent solutions using leading-edge technology.

Sponsor-dedicated: Working fully embedded within one of our pharmaceutical clients, with the support of Cytel right behind you, you'll be at the heart of our client's innovation. As a Senior Statistical Programmer you will be dedicated to one of our global pharmaceutical clients; a company that is driving the next generation of patient treatment, where individuals are empowered to work with autonomy and ownership. This is an exciting time to be a part of this new program. Position Overview: As a Senior Statistical Programmer, you will leverage your advanced SAS programming skills and proficiency in CDISC standards (SDTM & ADaM) to support or lead one or more Phase I-IV clinical trials. This role can be performed as fully remote. Our values - We believe in applying scientific rigor to reveal the full promise inherent in data. - We nurture intellectual curiosity and encourage everyone to approach new challenges with enthusiasm and the desire for discovery. - We believe in collaboration and invite a diversity of perspectives, drawing on a variety of talents to create a wealth of possibilities. - We prize innovation and seek intelligent solutions using leading-edge technology.

Sponsor-dedicated: Working fully embedded within one of our pharmaceutical clients, with the support of Cytel right behind you, you'll be at the heart of our client's innovation. As a Senior Statistical Programmer you will be dedicated to one of our global pharmaceutical clients; a company that is driving the next generation of patient treatment, where individuals are empowered to work with autonomy and ownership. This is an exciting time to be a part of this new program. Position Overview: As a Senior Statistical Programmer, you will leverage your advanced SAS programming skills and proficiency in CDISC standards (SDTM & ADaM) to support or lead one or more Phase I-IV clinical trials. This role can be performed as fully remote. Our values - We believe in applying scientific rigor to reveal the full promise inherent in data. - We nurture intellectual curiosity and encourage everyone to approach new challenges with enthusiasm and the desire for discovery. - We believe in collaboration and invite a diversity of perspectives, drawing on a variety of talents to create a wealth of possibilities. - We prize innovation and seek intelligent solutions using leading-edge technology.

Sponsor-dedicated: Working fully embedded within one of our pharmaceutical clients, with the support of Cytel right behind you, you'll be at the heart of our client's innovation. As a Senior Statistical Programmer you will be dedicated to one of our global pharmaceutical clients; a company that is driving the next generation of patient treatment, where individuals are empowered to work with autonomy and ownership. This is an exciting time to be a part of this new program. Position Overview: As a Senior Statistical Programmer, you will leverage your advanced SAS programming skills and proficiency in CDISC standards (SDTM & ADaM) to support or lead one or more Phase I-IV clinical trials. This role can be performed as fully remote. Our values - We believe in applying scientific rigor to reveal the full promise inherent in data. - We nurture intellectual curiosity and encourage everyone to approach new challenges with enthusiasm and the desire for discovery. - We believe in collaboration and invite a diversity of perspectives, drawing on a variety of talents to create a wealth of possibilities. - We prize innovation and seek intelligent solutions using leading-edge technology.

Sponsor-dedicated: Working fully embedded within one of our pharmaceutical clients, with the support of Cytel right behind you, you'll be at the heart of our client's innovation. As a Senior Statistical Programmer you will be dedicated to one of our global pharmaceutical clients; a company that is driving the next generation of patient treatment, where individuals are empowered to work with autonomy and ownership. This is an exciting time to be a part of this new program. Position Overview: As a Senior Statistical Programmer, you will leverage your advanced SAS programming skills and proficiency in CDISC standards (SDTM & ADaM) to support or lead one or more Phase I-IV clinical trials. This role can be performed as fully remote. Our values - We believe in applying scientific rigor to reveal the full promise inherent in data. - We nurture intellectual curiosity and encourage everyone to approach new challenges with enthusiasm and the desire for discovery. - We believe in collaboration and invite a diversity of perspectives, drawing on a variety of talents to create a wealth of possibilities. - We prize innovation and seek intelligent solutions using leading-edge technology.

Sponsor-dedicated: Working fully embedded within one of our pharmaceutical clients, with the support of Cytel right behind you, you'll be at the heart of our client's innovation. As a Senior Statistical Programmer you will be dedicated to one of our global pharmaceutical clients; a company that is driving the next generation of patient treatment, where individuals are empowered to work with autonomy and ownership. This is an exciting time to be a part of this new program. Position Overview: As a Senior Statistical Programmer, you will leverage your advanced SAS programming skills and proficiency in CDISC standards (SDTM & ADaM) to support or lead one or more Phase I-IV clinical trials. This role can be performed as fully remote. Our values - We believe in applying scientific rigor to reveal the full promise inherent in data. - We nurture intellectual curiosity and encourage everyone to approach new challenges with enthusiasm and the desire for discovery. - We believe in collaboration and invite a diversity of perspectives, drawing on a variety of talents to create a wealth of possibilities. - We prize innovation and seek intelligent solutions using leading-edge technology.