Senior Manager, Biostatistics

About Codera

Codera is a Tang Capital company that provides in-house end-to-end drug development capabilities for its portfolio companies. Founded in 2002, Tang Capital is a life-sciences focused investment company that creates, acquires and finances companies that develop and commercialize pharmaceutical products.

Position Summary

The Senior Manager, Biostatistics will participate in the design, development and quality control process for the extraction, transformation, review, analysis and submission of clinical data for individual studies. This position will also provide statistical input into study design and analyses of data. The Senior Manager, Biostatistics will participate in technology development and process improvement initiatives as well as programming support. The Senior Manager, Biostatistics will be accountable for the validity and quality of statistical input and deliverables for clinical studies.

We are seeking a candidate who is comfortable starting in a consulting capacity, with a clear path toward a full-time, permanent opportunity based on mutual fit and performance.

Essential Duties and Responsibilities

Provide statistical expertise and input to clinical development programs 

Author detailed statistical analysis plans including the evaluation of study objectives/endpoints, the structure and content of analysis datasets, derivation of variables and sample size/power calculation 

Plan the contents and format of tables, listings and figures (TLFs) to be programmed for the clinical study report (CSR)

Review CDISC datasets and associated documentation/metadata 

Review Data Management associated documentation and setup of databases

Support the generation of posters and publications 

Develop statistical programs for data review including detailed listings to identify data issues and vendor reconciliation 

Conduct statistical programming as needed to support quality control of analyses and the success of clinical development programs 

Review and provide input on project related clinical documents from a statistical perspective including protocols, development safety update reports, investigator brochures, and CSRs 

Assist with development of SOPs and quality procedures for biostatistics

Qualifications

Master’s Degree in Biostatistics required

PhD Degree preferred

Minimum 4-6 years of biostatistics experience working in the pharmaceutical industry required

Must be proficient in SAS with an understanding of CDISC datasets standards 

Familiarity with Phoenix WinNonlin for non-compartmental analyses preferred

Advanced and broad knowledge of statistical methods and an understanding of pharmaceutical industry practices 

Must be self-motivated, well-organized, detail-oriented and have excellent written and verbal communication skills 

Results-driven and capable of managing competing high-priority assignments with a proven track record of achieving deliverables within specified timelines 

Ability to establish and maintain collaborative working relationships with internal and external stakeholders

Codera, LLC is an Equal Opportunity Employer. We do not discriminate on the basis of race, color, religion, sex (including pregnancy, sexual orientation, or gender identity), national origin, age, disability, genetic information, veteran status, or any other legally protected status.

Codera, LLC participates in the E-Verify program. Candidates must be legally authorized to work in the United States.

This job description is not intended to be an exhaustive list of duties, responsibilities, or qualifications. The company reserves the right to modify duties or requirements at any time.