The Senior Statistical Analyst will develop SAS programs/macros for reporting clinical trial results in the pharmaceutical business unit. Successful candidates will assess the feasibility of the statistical analysis plan (SAP) and the delivery timelines, investigate issues with the data and report findings back to the team, and carry out the SAPs to generate tables, listings, and figures (TLFs) for clinical study report writing. Additional tasks include validating/crosschecking results, mentoring junior analysts, overseeing the outsourcing on statistical programming, and participating in the development and maintenance of standard operating procedures (SOPs). This position can be located in either Rochester, NY or Madison, NJ.
Specific Job Duties:
Bausch + Lomb is one of the best-known and most respected healthcare brands in the world, offering the widest and finest range of eye health products including contact lenses and lens care products, pharmaceuticals, intraocular lenses and other eye surgery products. The company is solely dedicated to protecting and enhancing the gift of sight for millions of people around the world – from the moment of birth through every phase of life. Our mission is simple yet powerful: Helping you see better to live better.
- Develop and execute statistical analyses of clinical trial data for regulatory and marketing studies and ISS/ISE, and for responding to questions from regulatory authorities.
- Communicate with clinical data managers, medical writers and other colleagues on data quality issues, clarifications of analysis strategies etc. in the creation, implementation, and maintenance of statistical programming deliverables.
- Participate in the review of Case Report Forms (CRFs), CRF annotations, SAPs, and TLFs.
- Oversee the work of other programmers and guide them in implementing programming methodologies for highly complex situations. Check quality of works performed.
- Develop efficient programming processes.
- Develop SOPs and training guidelines related to statistical programming.
- Create/Review derived data set specifications and the related analysis data sets.
- Participate in Due Diligence evaluations.
Bausch + Lomb is an Equal Opportunity Employer.
Education: Master’s degree in quantitative sciences (e.g., Statistics, Mathematics, Computer Science)
Experience: 5 years’ experience in SAS programming in a pharmaceutical/biotech or CRO environment.
Proficiency in Base SAS, SAS reporting modules, SAS macros, SAS Proc Report, ODS, SAS Proc SQL, and SAS STAT/GRAPH. CDISC experience is a must.
Excellent verbal and written communication and organizational skills required.
Experience working with CROs preferred.
NDA submission experience preferred.
United States-New Jersey-Madison Site
United States-New York-Rochester Global Eye Health Center Site
Bausch + Lomb - 20 months ago