Principal Biostatistician - HTA

A specialist contract research organisation to the pharmaceutical industry is looking for a talented Principal Statistician to join their dynamic team in London. The role of the Principal Statistician is to provide statistical support to the statistics and programming department across a range of projects, clients and therapeutic areas. The Principal Statistician may also perform a supervisory role (e.g. line management and/or project management).

Job Responsibilities

• Perform technical review and provide input into clinical trial documents including protocols, CRFs, CSRs.
• Author and review study SAP, TFL shells and dataset specifications.
• Support study and/or compound level activities advising on study design and statistical issues across phases and therapeutic areas.
• Author, validate and document SAS programs for datasets, TFLs and macros, applying good programming practice.
• Application of complex statistical techniques (e.g. mixed effects, non-linear modelling, Bayesian, advanced survival), model checking and interpretation.
• Identify and implement appropriate sample size method using software or simulations.
• Identify data and standards issues and resolve or escalate as appropriate.
• Awareness of emerging standards and associated impact to ongoing and future planned trials.
• Maintain proficiency in statistical methodology.
• Line management of statisticians, programmers and other technical staff.
• Accountable for overall performance of direct reports.
• Provide coaching and mentoring of staff to achieve "excellence". Direct employee career development and ensure line reports receive appropriate training to perform their day-to-day jobs.
• Proactive management of resource, scope change and risks.
• Manage the delivery of projects to budget.
• Manage client expectations and issue resolution.
• Present study updates internally and at client meetings.
• Share scientific, technical and practical knowledge within the team and with colleagues.
• Perform work in full compliance with applicable internal and client policies, procedures, processes and training.
• Build effective collaborative working relationships with internal and client team members.
• Ensure learnings are shared across projects or studies.
• Develop and provide internal technical training where appropriate.
• Lead process improvement initiatives.

Skills and Requirements

• MSc or PhD in Statistics/Biostatistics (or equivalent).
• At least 6 years of relevant industry experience.
• Understanding of clinical drug development process, relevant disease areas, endpoints and different study designs.
• Awareness of industry and project standards & ICH guidelines.
• Excellent verbal and written communication skills.
• Interpersonal/teamwork skills for effective interactions.
• Proficiency in data handling using SAS or other statistical software (e.g. R).
• Self-management skills with a focus on results for timely and accurate completion of competing deliverables.
• Demonstrated problem solving ability and attention to detail.
• Ability to work independently and as part of a team.
• Ability to manage a portfolio of projects and/or people.

Benefits

Benefits include, private healthcare, travel insurance for business and leisure, summer and Christmas party, pension, cycle to work scheme, death in service, season ticket loan, membership to PSI.

To Apply

ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

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