The Senior Manager, Biostatistics is responsible for statistical input to clinical studies, regulatory filings and interactions with regulatory agencies.
Acts as Lead Biostatistician on individual studies, across related studies and for integrated summaries. May act as Program Lead Biostatistician.
Acts as a Lead Statistician supporting the design and reporting for Phase I to IV clinical studies, regulatory filings and interactions.
- Lead team of statisticians to meet statistical reporting timelines and activities.
- Attend meetings with regulatory agencies and respond to regulatory questions regarding submissions and study designs.
- Solve complex statistical issues.
- Provide input and support to statisticians within Biometrics.
- May act as Program Lead Statistician.
- May act as a deputy for the Biometrics department lead.
- Oversee and review of statistical activities and tasks performed by CROs, including QC of statistical analyses.
- Work closely with SAS programming colleagues and the SAS programming group.
- Can sign documents (‘pp.’) on behalf of other Biometrics personnel in time of absence, where experience allows, or if individually authorised by suitably experienced departmental personnel.
- Input into the development of departmental processes, including standard working practices and operating procedures.
- May lead outsourcing statistical activities within a program.
- Lead and manage team of statisticians to meet statistical deliverables.
- Provide technical support and input to statisticians and statistical tasks.
- Act as a statistical point of contact within a program.
- Act as Lead Statistician on clinical trials.
- Review of deliverables from CROs.
- Interact with report writers in the production of integrated clinical reports and other documents.
- Perform quality control review of work completed by other members of the team.
- Perform statistical analyses of data and interpret results, ensuring validity of conclusions.
- Interact with other disciplines to ensure successful execution of studies.
- Provide input into regulatory briefing documents, responses, submissions and meetings.
- Work collaboratively with other functional leads to provide statistical input where necessary.
- Operates in accordance with the GW corporate values of being patient driven, passionate, innovative, collaborative, accountable, having integrity and achieving excellence.
- Works in accordance with the systems in place with regards to health & safety, security and the environment.
4.KEY ATTRIBUTES/SKILLS/EDUCATION – ESSENTIAL:
- Familiar with data from clinical trials.
- Extensive knowledge of statistics and relevant statistical topics and current statistical thinking within the industry.
- Thorough knowledge of applicable regulatory requirements and guidelines, e.g. ICH Guidelines.
- Experience with complex statistical techniques.
- Significant/relevant CRO/Pharma experience.
- Experience leading teams of statisticians.
- Extensive experience with oversight of CROs.
- Demonstrated leadership skills.
- Masters degree or equivalent in statistics or related discipline with a statistical focus.
- Proficient in the use of computers and especially the Windows operating system and Microsoft products.
- Proficient in the use of the SAS system, especially SAS Base; experience of the use of SAS/Graph and SAS/Stat would be an advantage.
Attributes and Behaviours:
- Able to work in a fast-paced, flexible, team-oriented environment.
- Possess excellent interpersonal and communication skills (written and verbal).
- Strong attention to detail with a view to bring studies to a quality conclusion.
- Flexible, positive, creative thinker, good communicator.
- Be able to work without close supervision. Well-developed time management skills are important.
5.KEY ATTRIBUTES/SKILLS/EDUCATION – DESIRABLE:
- PhD or equivalent in statistics or related discipline with a statistical focus.
- Bayesian and adaptive design experience.
- Significant CRO/Pharma experience.