If you are looking for an environment where you can make a difference, then DCN Diagnostics just may be the right place for you!
DCN Dx is currently going through an exciting stage of global expansion and we are looking for self-motivated individuals who want to help us get there and make a difference along the way.
We are seeking a Principal Biostatistician to work with the DCN Dx Clinical, R&D and Engineering teams. A successful candidate will be a strategic member of a fast-paced and interactive CDMO.
As Principal Biostatistician, you will provide statistical consulting to our Clinical Research team and clients to develop statistical analysis plans, contribute to clinical study design and protocols, and drive the analysis and reporting of clinical data. You will also work with our R&D and Engineering teams to properly power V&V studies. Ideally, you'll have over 7 years of experience (with a MS) working in industry, with significant IVD experience. This position will be located at the company's headquarters, in Carlsbad, CA (north county San Diego).
- Provide statistical consulting including, but not limited to sample size estimation, power calculation and study design and in the analysis and interpretation of study data. Works on complex statistical problems in which analysis of data requires an in-depth evaluation of various factors.
- Provides statistical methodology sections of study protocols, writes statistical analysis plan, performs statistical analysis and writes statistical analysis report.
- Provides statistical consulting to the R&D and Engineering departments at DCN Dx.
- Develops systematic documentation of methods, results and statistical programming.
- Writes appropriate SOPs.
- Leads statistical education for other DCN Dx departments. Leverages regular contact with scientific community to identify new and interesting ideas that could benefit DCN Dx or our clients.
- Builds usable analysis programs for R&D, Engineering and Manufacturing (for example: QC and lot release).
- Effectively utilizes external resources to meet project objectives.
- Works closely with the Clinical, Regulatory and Quality departments for successful clinical studies and regulatory submissions.
- Liaise with clients on issues related to Biostatistics.
- Demonstrates and advocates the DCN Dx Culture of customer service and excellence.
- MS in statistics, biostatistics or mathematics or a related field with 7+ years of relevant work experience.
- 7+ years for MS or 5+ years for PhD of relevant work experience.
- Strong consulting skills, excellent oral and written communications and interpersonal skills. Ability to work in teams is critical. Statistical computing in SAS is required.
- Familiar with statistical programs such as SAS, S-Plus, JMP, PASS, R, etc.
- A thorough knowledge of experimental design, general linear model, categorical analysis and statistical computing. Familiarity with survival analysis and nonlinear models is a plus.
Ideal candidate will have:
- PhD in statistics, biostatistics or mathematics.
- 7+ years for MS or 5+ years for PhD with regulatory submission experience and knowledge of relevant regulatory guidelines.
- Be customer focused.
- Be resilient and innovative in our fast-paced environment.
- Innate ability to foster relationships with others.
- Strong sense of urgency and ability to work independently as well as collaboratively.
- Excellent communication skills, both written and verbal.
What DCN Dx Has to Offer you
Aside from working alongside brilliant, dedicated and passionate people, we also provide great benefits:
- Competitive compensation
- Health insurance, including medical, dental, and vision
- 401(k) with employer contribution
This is a full time position