Lead Statistical programmer/Team Leader
Quotient Sciences is a drug development and manufacturing accelerator providing integrated programs and tailored services across the entire development pathway. Cutting through silos across a range of drug development capabilities, we help biotech and pharma customers save precious time and money in getting drugs to patients.
As a growing and successful business, we employ more than 1,300 talented individuals globally, located at state-of-the-art development, manufacturing, clinical and data sciences facilities in the UK and USA.
Science, Agility and Culture are the core components that define Quotient Sciences, enabling us to do what we do in the way that we do it. People join Quotient Sciences because we are a respected member of the drug development community, driven by an unswerving belief that ideas need to become solutions, and molecules need to become cures, fast. Because humanity needs solutions, fast.
Function as a Team Leader in the Statistical Programming group within the Data Sciences department, responsible for the planning, scheduling and management of a team of programmers, ensuring compliance with timelines and quality. Conduct and document regular meetings and performance appraisals with direct reports. Function as a Lead Statistical Programmer. Participate in the creation and maintenance of statistical programming study documentation, and process improvement. Support special\non-study related projects and is responsible for assigned standards within the group.
Main tasks and responsibilities
- Provide direct daily supervision of assigned staff - assign, schedule and prioritize workload.
- Assist in managing statistical programming resource for studies assigned to team
- Conduct and document motivating, timely performance feedback on a routine basis as well as for formal performance appraisals.
- Ensure adequate mentoring and training for assigned team members.
- Act as Lead Statistical Programmer
- Oversee and manage the receipt, loading and reconciliation of external data, perform routine and non-routine SAS consistency checks
- Oversee and participate in activities relating to the development of dataset specifications, dataset programming and validation
- Oversee and participate in activities relating to the production of safety and PK output, including QC, validation and peer review
- Oversee and participate in activities relating data transfers and define.xml, including the production and review of relevant documentation
- Monitor and review programs, specifications and output of group members, ensuring adherence to departmental Standard Operating Procedures and quality standards.
- Maintain organized, complete and up-to-date study documentation, ensuring studies are archive-ready in a timely manner
- Undertake the design and programming of standard and non-standard SAS macros
- Mentor and train less experienced group members, demonstrating level 3 competencies for statistical programming tasks
- Participate in the development of departmental processes, procedures, and departmental training programs.
- Lead and co-ordinate special\non-study related projects
- May be responsible for assigned standards, eg library of template programs, ensuring these remain current and are adhered to by other members of the group
- Participate in sponsor audits and represent statistical programming at multi-disciplinary meetings
- Maintain awareness of developments SAS and related software
- Maintain an awareness of industry-wide initiatives such as CDISC, including define.xml
- Input into statistical programming timelines with the study team, monitor productivity on studies, track progress and communicate problems\backlogs with study team and management
- Maintain an awareness of the study scope of work and notify senior management of all sponsor requests that are outside current scope
- Ensure that all tasks comply with departmental SOPs.
- Responsible for ensuring that a safe working environment is maintained for themselves and their colleagues by observing all safety procedures and working methods, and by reading, understanding and following all safety documents issued or notified to them
- To undertake other such tasks as might reasonably be requested from time to time by their supervisor and to ensure that their work is conducted in a co-operative and flexible manner.
- Minimum degree or masters degree qualification in a science or numerate subject
- An equivalent combination of education and experience may be accepted as a satisfactory substitute for the specific education and experience listed above
- Significant related experience in industry\area\discipline
- Requires effective oral and written communication skills, presentation skills, and attention to detail. Proficiency in Word, Excel, and Email.
- Working knowledge of clinical data and ICH\Good Clinical Practices.
- Logical thinking, problem-solving abilities and the ability to multi-task and prioritise under deadlines.
- Should be able to appropriately balance quality and speed, working independently with only general direction. Interact and work as part of a multi-disciplinary team.
- Ability to be flexible and adapt to change
In return, you will receive a competitive salary, a generous benefits package, excellent training and development, as well as an exciting career within a fast paced and dynamic business.
Our Commitment to Diversity & Inclusion
Quotient Sciences are advocates for positive change and conscious inclusion.
We strive to create a diverse Quotient family by remaining committed to the development of our culture, equality, mindset, diversity & inclusion in the workplace.