Senior Manager/Associate Director, 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/Associate Director, 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/Associate Director, Biostatistics will participate in technology development and process improvement initiatives as well as programming support. The Senior Manager/Associate Director, 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

The job description is not designed to cover or contain a comprehensive list of activities, duties or responsibilities that are required . They may change, or new ones may be assigned at any time with or without notice.

The estimated annual base salary for this position is $145,000 - $175,000 , commensurate with experience and skills.

T his role may be eligible for discretionary bonuses and other incentive programs .

Codera provide s a comprehensive benefits package designed to support employees’ physical, mental and financial health and include employer sponsored insurance plans including medical, dental and vision coverage; generous paid time off ; retirement plan options and additional wellness and professional development programs

Codera provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state, or local laws.

Codera participate in E ‑ Verify. All newly hired employees are required to complete the E ‑ Verify process as part of their employment eligibility verification .