Senior/Principal Statistical Programmer SAS + R (Remote)

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 Principal 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.

This position reports to the Director, Biostatistics and Programming in the FSP Services business unit in Cytel. The Principal Statistical Programmer works independently with only concept level instruction and very little supervision, tracks progress, and provides expert technical support to team members.
We are looking for a highly experienced senior statistical programmer who will work on clinical development programs on different therapeutic areas and participate in overseeing CRO programmers to ensure that data summaries are delivered in a consistent, high-quality manner.

This individual will be responsible for implementing all reporting and analysis activities for the Sponsor clinical trials.

As a Principal Statistical Programmer, your responsibilities will include:

Generate SDTM, ADaM specifications, datasets, reviewer's guide and define.xml files for multiple studies

Develop SAS programs which generate datasets, complex listings, tables (including those with descriptive and standard inferential statistics in collaboration with a Statistician), and complex graphs

Deliver high-quality statistical programming results including developing, validating, and maintaining SAS and/or R programs tailored to clinical development programs' needs

Participate in overseeing CRO's statistical programming deliverables for multiple clinical studies to ensure high-quality and meet the pre-specified timelines

Support the preparation of clinical study reports, regulatory submissions, publications, annual DSUR, and exploratory analyses

Understand and follow FDA regulations which affect the reporting of clinical trial data. This includes good clinical practice and guidelines for electronic submissions.

Contribute to the creation, maintenance, documentation, and validation of standards for programming tools, outputs, and macros

Participate in the development of CRFs, edit check specifications, and data validation plans

Provide review and/or author data transfer specifications for external vendor data

Collaborate with internal and external functions (e.g. CROs, software vendors, clinical development partners, etc.) to ensure meeting project timelines and goals

Provide review and/or author SOPs and/or Work Instructions related to statistical programming practices

Here at Cytel we want our employees to succeed and we enable this success through consistent training, development and support. To be successful in this position you will have:

At a minimum bachelor's degree in computer science, data science, mathematics, or statistics major preferred

7+ years of experience as a Statistical Programmer on a Biotech/Pharma Clinical Development Biometrics Team or with a similar team and experience supporting drug development, medical device development, or intervention studies

Exceptional SAS programming skills and expertise in the development and implementation of statistical programming procedures and processes in a clinical development environment

Extensive applied experience of CDISC standards (SDTM, ADaM, and Define.xml), medical terminology, clinical trial methodologies, and FDA/ICH regulation





Experience supporting regulatory submissions, interacting with the FDA and/or general regulatory authorities

Must be able to work independently

Outstanding communication skills (written and verbal) and strong leadership skills

Preferred Qualifications (nice to have)

Prior work experience with pharmacokinetic data and the neuroscience field,

proficiency in languages or tools other than SAS (e.g., R, Python, and Java, Shiny, Markdown, Unix/Linux and git)

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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.

Senior Sales Executive, Medical Device Consulting Services, EMEA (Remote)

Emergo by UL's Human Factors business unit is a global leader in Human Factors Engineering (HFE) services, with team members in the US, Europe, and Asia. Emergo by UL's HF staff consists of human factors professionals who perform research, design, and usability studies primarily for the medical and pharmaceutical industries.

We are seeking a service-minded, customer-centric, proven consultative Senior Sales Executive in Europe to join our team.

This senior sales executive will be customer-facing and lead sales of premium HF advisory services in the EMEA region, which requires advanced technical credibility and subject matter expertise to sell and respond to customer inquiries.

We offer flexibility in how and where you work. This position can be based remotely or in a hybrid model from one of our offices in Barcelona (Spain), Basingstoke (UK), or The Hague (Netherlands).

Serves as primary point of contact for specialty Human Factors advisory services throughout sales cycle, from initial contact through project scoping and contract execution

Responsible for understanding specific customer needs, articulating Emergo by UL's value proposition in client presentations and proposals and managing client interactions to close sales

Meets or exceeds quarterly and annual sales quotas; works closely with subject matter experts to craft customized advisory service solutions that deliver value and address customer needs

Develops sales pipeline via proactive outreach and attendance of trade shows and conferences

Builds trust and engages with customers to identify their specific needs and pain points, e.g. understanding the opportunities surrounding Human Factors in customer's product development process, and integrating HF solutions in key steps

Contributes to the development of marketing strategy and tactics for Human Factors business, including but not limited to identifying key industry events at which to represent the company

Advises Human Factors business leadership on evolving customer needs, pain points, and industry trends to help inform future offerings

Maintains ongoing plan to prioritize portfolio of target accounts and maintains relationships throughout the year

Gains Human Factors knowledge quickly via internal training program and independent proactive research, including maintaining knowledge base around Human Factors best practices





Proactively identify and target key customers for needs discovery and opportunity identification for Human Factors

Bachelor's and/or graduate degree, in business, human factors engineering, biomedical engineering, life science or related field

English proficiency must be at least C1 level

5+ years of consultative sales experience and proven ability to meet and exceed sales targets (minimum $3 million/year)

Medical device and/or life science industry experience required

Human Factors Engineering knowledge and experience preferrable

Business acumen and deep understanding of business sales processes

Proficient in MS Office (Word, Power Point, Excel, Outlook), and CRM software

Ability to travel including client visits and working at trade shows, up to 30%

A global leader in applied safety science, UL Solutions (NYSE: ULS) transforms safety, security and sustainability challenges into opportunities for customers in more than 110 countries. UL Solutions delivers testing, inspection and certification services, together with software products and advisory offerings, that support our customers' product innovation and business growth.
The UL Mark serves as a recognized symbol of trust in our customers' products and reflects an unwavering commitment to advancing our safety mission. We help our customers innovate, launch new products and services, navigate global markets and complex supply chains, and grow sustainably and responsibly into the future.

Our science is your advantage.

UL LLC has been and will continue to be an equal opportunity employer. To assure full implementation of this equal employment policy, we will take steps to assure that: Persons are recruited, hired, assigned and promoted without regard to race, color, age, sex or gender, sexual orientation, gender identity, gender expression, transgender status, religion, creed, national origin, ethnicity, citizenship, ancestry, disability, genetic information, military or veteran status, pregnancy, marital or familial status, or any other protected category under applicable law.

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