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Director of Biostatistics

  • LocationSan Carlos, CA 94070 - United States
  • Work TypeFull Time - Permanent
  • Positions1 Position
  • Published At:10 days ago

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  • Job no: 37524
  • Categories: Clinical

Job Description


Our client, a leading biopharmaceutical company, is currently recruiting a Director of Biostatistics who will infuse the Biostatistics Team with their talent, energy and leadership skills. This is an exceptional opportunity to join a corporate culture that is known for its innovative and growth-oriented vision. Responsibilities include:


1) Provide biostatistics support to company’s expanding portfolios

2) Lead development and optimization of biometric processes with specific focus on efficiency and quality, while maintaining and exceeding industry best practices

3) Provide strategies for clinical study design, endpoint selection, sample size calculations, randomization schedules, statistical analysis plans and data interpretation in collaboration with all team members

4) Evaluate and implement innovative study designs and novel statistical methodologies, as appropriate across each of the therapeutic areas

5) Act as the primary contact and provide oversight for all biostatistics related activities outsourced to CROs and external vendors

6) Review protocols and prepare statistical methods sections

7) Generate and/or review randomization schedule

8) Prepare and review detailed statistical analysis plan

9) Create and review programming specifications for analysis datasets and TLFs

10) Coordinate and lead team review and consolidation of comments for SAP and mock-TLFs

11) Lead the study unblinding and validate TLFs post database lock

12) Lead and manage external biostatistics and statistical programming resources supporting studies and programs

13) Develop SOPs, work instructions, guidelines, data standards and processes, as needed to govern the biostatistics group and deliverables

14) Ensure accurate and statistically valid deliverables

15) Coordinate achievement of major statistical deliverables and milestones in collaboration with other functions

16) Complete submission of clinical data to various agencies

17) Provide statistical leadership for preparation of marketing applications to FDA, EMA and other worldwide regulatory agencies


Critical Requirements


1) A university degree is required. Although all candidates are welcome and encouraged to apply, preference will be given to those with degrees in a relevant field

2) Appropriate full-time work experience is mandatory (no students or fresh graduates please)

3) Recent experience in the biopharmaceutical industry is strongly preferred

4) Preference will be given to candidates with recent experience in clinical management


For the right leader, this is a wonderfully rewarding role with tremendous growth prospects. If you are qualified and think you're a strong fit for this role, please apply ASAP. We thank all applicants, but only candidates who meet our client's criteria will be contacted.


Compensation and Other Details


Base Salary: Highly competitive package, commensurate with experience

  • Published on 29 Apr 2021, 1:32 PM