Head of Statistical Programming

Greater Copenhagen, Denmark

BRIEF COMPANY PROFILE
Our client was founded more than 25 years ago in Denmark as a biotech company with an exclusive focus on the design and development of innovative peptide-based medicines with an ambition of providing more safe and effective treatments in areas of high unmet medical needs. Celebrating more than 25 years of achievements, our client is a world leader in discovering and developing peptide therapeutics. The advanced peptide-based solutions and products aim to help thousands of people suffering from metabolic and gastrointestinal diseases. Since the foundation, the company's R&D has pioneered the peptide therapeutics area, resulting in two launched peptide-based products and a rich portfolio of active R&D projects. Our client is at the cutting edge of peptide analogs, with a strong scientific foundation, and has advanced more than ten novel peptide analogs into clinical development. The corporate strategy's refocusing has placed pipeline growth and scientific excellence at the highest priority, founded in strong commercial and strategic partnerships along the R&D value chain. With two products on the market and three candidates in late-stage development, our client is a success story in Danish biotech. Designing and engineering peptide analogs with enhanced biological activity, extended duration of action, and increased stability has been the driving formula for the success of our client. The Statistical Programming Team The business model of our client engulfs nearly all clinical trial activities being outsourced; however, statistical programming deliverables have been handled internally for some trials. The Statistical Programming team is responsible for outsourcing and oversight of the end-to-end programming activities from trial start to final clinical trial report. The team holds a critical role in being responsible for ensuring that all data from clinical trial(s) are delivered from our clinical CRO according to Clinical Data Interchange Standards (CDISC) requirements. The team has a pivotal role in individual trials and on program level, e.g., in preparing key results and regulatory submissions and requests. The team works closely with data managers and biostatisticians, as well as other members of the trial team, to ensure the timely execution of clinical trial activities. The involvement of Statistical Programming starts early with input to Clinical Trial Outlines/Protocols and CRO selection and award.

THE POSITION
Our client is looking to bring on board an experienced, driven, and high-caliber professional to lead the Statistical Programming Department as part of the Biometrics Leadership Team (BLT). This is a new position and, hence, a department expansion. The Head of Statistical Programming will have a focal role within the critical pathway in clinical development, leading to the generation of high-quality, reliable, and statistically sound data from clinical trials conducted for our client. As Head of Statistical Programming, the ideal candidate would function as both a strategic leader and technical overseer while acting as a playing coach, ensuring that the programming team’s work aligns with regulatory standards and supports the company’s broader clinical and regulatory goals. This position will be responsible for developing Our client's competencies within statistical programming. Defining a data strategy, in collaboration with the BLT, will be key to leveraging the value of our client’s clinical data. The ideal candidate should bring extensive experience in statistical programming and be capable of delivering strategic input and managing cross-functional collaboration. Finally, this position requires strong leadership, a deep understanding of biostatistics, and a collaborative, analytical mindset to drive and inspire a high-performing team.

POSITION PROFILE
Position title:	Head of Statistical Programming.

Reporting line:	Vice President, Biometrics.

Reporting to the position:	5 FTEs (Statistical Programmers).

Location:	Greater Copenhagen.

Traveling:	Limited.

Responsibilities & Tasks:	Review clinical data and leading and setting the direction for the Statistical Programming team. Securing high quality data standards by using knowhow to improve the department’s procedures and secure best practices. Leading the development of standard programs for creating datasets within the framework of CDISC (SDTM and ADaM). Leading the development of standard programs for tables, figures, and listings. Ensuring oversight of CRO activities for outsourced trials. Hands-on responsibilities with statistical programming activities. Contributing to defining our client's future data strategy.

Key success criteria:	Developing and implementing a robust statistical programming strategy that aligns with organizational and regulatory goals, while building and managing a cohesive, well-functioning team of statistical programmers with clear roles, responsibilities, and professional development plans. Successful governance and delivery of high-quality statistical programming activities. Successful execution of statistical programming projects and processes. Establishing and maintaining strong relationships with CROs, ensuring high-quality data delivery and seamless collaboration across global clinical trials. Keeping up with the latest industry specific authority data requirements, CDISC standards and SAS programming to secure the continued use of high-quality data standards. Securing a high level of cross-disciplinary collaboration with all relevant stakeholders.

CANDIDATE PROFILE
Educational background:	Ideally a MSc. degree in relevant field (biostatistics, mathematics, life sciences, computer science, etc.).

Language:	Fluency in English (verbally and written)

Ideal experience:	Preferably 3+ years with line leadership or 5+ years of project leadership in statistical programming. 7+ years of statistical programming experience in the pharmaceutical or biotech industry. Experience with outsourcing and oversight of clinical trial activities, including CROs. Solid understanding of end-to-end clinical development processes. Advanced proficiency in SAS programming, and experience with CDISC data standards. Solid foundation in biostatistics and understanding of statistical methodologies. Detailed understanding of good clinical practice (GCP), regulatory requirements and good programming practice (GPP). Proven track record of managing several projects and meeting deadlines, while adhering to industry quality and safety standards. Experienced and confident IT-user.

Personal & leadership competencies:	Inspiration and followership Inspires others, creates followership and encourages the achievement of joint set goals by promoting a sense of purpose. Provides inspiration for a positive work attitude and prompts a strong wish of the team to succeed. Direction and responsibility Ensures that peers have a clear understanding of, and commitment to direction and tasks. Organizes resources, takes action and directs others toward successful execution. Drives projects forward to reach pivotal objectives, makes things happen and follows through. Has the ability to navigate in an organization where priorities can change fast and is able to reallocate resources on demand. Involvement, commitment and prioritization Participates actively in considerations, decisions and actions, offers his or her own opinion and makes own abilities available, while assessing the importance of decisions and actions with analysis of the most important issues first. Communication Communicates the central issues in a clear, fluent and precise manner, and is able to keep the recipients' attention. Is attentive to the needs of others when speaking and produces written material which is clear, fluent, precise and easy to understand. Planning  and structure Plans a focused course of action for oneself and peers and ensures an appropriate assignment of tasks for employees. Schedules an optimal use of the available resources and is able to plan ahead. Works systematically, organizes work and effort and is methodical while holding on to commenced tasks and projects. Proactively anticipates and identifies complex issues and problems. Coaching/support Is actively trying to improve the skills and talent of the employees by giving positive and constructive feedback. Provides training and tasks with a view to challenge their skills and encourage their development. Follow up  Plans actions to secure optimal use of time and resources, compares achieved results to set objectives, follows up on delegated tasks and decisions. Quality-minded Is concerned with reaching and maintaining quality; sets high standards for performance and execution – for oneself and for others.

Head of Statistical Programming

BRIEF COMPANY PROFILE

THE POSITION

POSITION PROFILE

CANDIDATE PROFILE

Share this opportunity