Director Biostatistics

  • Regeneron
  • Uxbridge, UK
  • 28/05/2022
Full time Data Engineering Big Data Statistics Biostatistics

Job Description

Job details

Job type

Full Job Description

This position is responsible for working with study team members to design latestage protocols, develop and write statistical analysis plans, and perform statistical analyses for interim and final reports to be submitted to regulatory agencies. The position will also support global submission activities, including review of clinical summaries and writing responses to regulatory review comments and information requests. Project level activities will include organization and scheduling of DMC reports, liaison and coordinate with the external partner, semi-annual safety reporting to regulatory agencies, and developing processes to provide AE information to adjudication committees. Attendance and statistical contributions at study team and project team meetings are expected. Within the BDM Department, leadership skills are needed to organize and schedule deliverables among the statisticians, statistical programmers and data managers. All BDM members are expected to support department infrastructure projects on an annual basis, including SOP improvement, development of white papers for innovative statistical methodology, new software user testing and support, etc. The position may include opportunities to mentor and manage less experienced biostatisticians.

Job Duties:

  • With minimal supervision and guidance from senior departmental staff, provide support to a clinical study team on all relevant statistical matters. Working directly with the SPT, medical directors and other study personnel, act as liaison to study team, ensuring that the clinical study is conducted in a manner that supports planned statistical analysis. Defend design at management forums (DPR and PRC).

  • With guidance from therapeutic area lead, work directly with SPTs on statistical elements of program strategy.

  • Contribute independently to design of a clinical study and help draft protocols or amendments. Perform relevant sample size calculations.

  • Develop statistical analysis plan (SAP) for complex studies. Perform/oversee statistical analysis defined in SAP, prepare statistical methods and results sections for the clinical study report (CSR). Provide statistical insight into interpretation and discussion of study results. Contributes tables and figures for management presentations.

  • Guide staff in clinical trial team representation. Represent department at GCST and SPT. SPT member.

  • Leads contributions to the preparation of material to be used in regulatory interactions, including drafting analysis plan and reviewing TFLs to be used in regulatory meetings, slides for ACMs, etc.Independently prepares and/or oversees TFLs to support CSRs, DSURs, IB and other documents. Collaborates with Medical Writing

    and Clinical to ensure tables are complete. Supports TFL production for ISE/ISS for submissions. Co-authors regulatory submissions.

  • Coauthors regulatory background packages, including those for pre-IND, EOP2, and pre-BLA meetings. Will contribute background material for ACMs and design additional analyses for ACM and as required for labeling negotiations. Attends pre-IND, EOP2, pre-BLA, label negotiation and AC meetings.

  • Leads and contributes to technical working groups and sets timelines and expectations for the deliverables. Authors new/revised SOPs and contributes to cross-functional EPIC workstreams.

Position Requirements

The following educational and previous clinical trial experience are required for this position:

  • PhD or MS in Statistics or Biostatistics or mathematics

  • 10 years for Director clinical trial experience in either a biotechnology or pharmaceutical company

  • Hands-on Phase IIb/III clinical trial experience and proficient in SAS and R programming

  • Excellent oral and written communication skills, and proficient in presenting power point presentations.

  • Although not required, previous support of regulatory submissions in the US, Europe, Canada, or Japan.

  • Although not required, previous clinical trial experience in the therapeutic areas of immunology and inflammation (example: atopic dermatitis, respiratory, gastroenteritis, etc.)

Does this sound like you? Apply now to take your first steps toward living the Regeneron Way! We have an inclusive and diverse culture that provides amazing benefits including health and wellness programs, fitness centers and stock for employees at all levels!
Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or maternity status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. We will ensure that individuals with disabilities are provided reasonable accommodations to participate in the job application process. Please contact us to discuss any accommodations you think you may need.