A bit about us:
We are a rapidly growing scientific research organization that works to develop vaccines and antibodies for HIV, tuberculosis, and infectious diseases! Having been around for over 20 years, we have grown to develop facilities in over 5 countries, and topped over $85 million in revenue in the past 2 years.
Why join us?
- Generous PTO plan, including 15 vacation days, 10 sick days, 3 personal days, 11 paid holidays, and year-end office closure!
- 401(k) with EXCELLENT company match
- Full Benefits; multiple plans to choose from
- FSA/HSA options
Job Details
You will oversee Contract Research Organization (CRO) vendors for our biostatistical and programming activities in support of Phase I - Phase IV clinical trials.
Responsibilities:
Requirements:
*PLEASE SEND ANSWERS TO THE FOLLOWING APPLICATION QUESTIONS TO andrea.silberberg@jobot.com DIRECTLY AFTER YOU APPLY*
1. Do you have experience working in the pharmaceutical industry (biotech, pharmaceutical company, CRO) in Biostatistics and SAS programming?
2. Do you have experience working with vaccine and/or clinical trials? If so, please elaborate.
3. Do you have good knowledge of WHODrug and MedDRA?
4. What annual salary are you targeting?
5. Will you be requiring sponsorship now or in the future?
Responsibilities:
- Provide oversight of outsourced biostatistical activities, coordination with other functional areas, and management of overall timelines, resources, and quality.
- Oversee biostatistics and programming-related responsibilities, including protocol development, trial start-up, randomization specifications, case report form (CRF) development, statistical analysis plan (SAP) and table shells development for interim and final analyses, statistical programming, safety reporting, Clinical Data Interchange Standards Consortium (CDISC) compliance, and all associated documentation for electronic trial master file (eTMF) filing.
- Act as a liaison between biostatistics vendors and the CD team, in particular Medical Monitors, Clinical Operations, and Data Management, by providing guidance on biostatistical aspects of clinical trials, such as randomization, CRF design, SAP development, safety reporting, resourcing, timelines, metrics, and other biostatistical support.
- Maintain biostatistics-related eTMF materials for clinical trials.
- Oversee biostatistical workflow of contracted CROs to maximize efficiency across all clinical trial biostatistics-related deliverables.
- Develop and review external (third party) data transfer agreements; consult with CROs to integrate external data into study programming process flow.
- Review SDTM and ADaM dataset specifications to ensure conformity to CDISC implementation guidelines and standards, as well as SDTM and ADaM datasets prepared by CROs to ensure consistency with dataset specifications.
- Provide/facilitate support as needed (technical, clinical) to ensure efficient action, collaboration and resolution of biostatistical issues.
- Assist QA team in performing vendor audits, as required.
- Write and revise relevant departmental Standard Operating Procedures (SOPs).
- Ensure compliance with departmental SOPs.
Requirements:
- MS or MPH degree in Statistics, Biostatistics, or related field is required.
- 7+ years of experience in the pharmaceutical industry (biotech, pharmaceutical company, CRO) in Biostatistics and SAS programming (Base SAS, SAS/STAT, SAS/GRAPH and SAS macro language)
- Design and analysis of safety, immunogenicity, and/or efficacy endpoints for early to late-stage vaccine trials are required.
- Experience developing SAS macros, database retrieval for data review and statistical programming, CDISC standards for programming of derived datasets, and using the SAS Output Delivery System
- Experience with various eDC platforms
- Solid knowledge of EMA and ICH regulations, CDISC, and FDA guidance is required
- Solid knowledge of WHODrug and MedDRA coding dictionaries is required.
*PLEASE SEND ANSWERS TO THE FOLLOWING APPLICATION QUESTIONS TO andrea.silberberg@jobot.com DIRECTLY AFTER YOU APPLY*
1. Do you have experience working in the pharmaceutical industry (biotech, pharmaceutical company, CRO) in Biostatistics and SAS programming?
2. Do you have experience working with vaccine and/or clinical trials? If so, please elaborate.
3. Do you have good knowledge of WHODrug and MedDRA?
4. What annual salary are you targeting?
5. Will you be requiring sponsorship now or in the future?
Jobot is an Equal Opportunity Employer. We provide an inclusive work environment that celebrates diversity and all qualified candidates receive consideration for employment 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.
Sometimes Jobot is required to perform background checks with your authorization. Jobot will consider qualified candidates with criminal histories in a manner consistent with any applicable federal, state, or local law regarding criminal backgrounds, including but not limited to the Los Angeles Fair Chance Initiative for Hiring and the San Francisco Fair Chance Ordinance.
Sometimes Jobot is required to perform background checks with your authorization. Jobot will consider qualified candidates with criminal histories in a manner consistent with any applicable federal, state, or local law regarding criminal backgrounds, including but not limited to the Los Angeles Fair Chance Initiative for Hiring and the San Francisco Fair Chance Ordinance.