Senior Statistical Programmer

4 weeks ago

King of Prussia, United States CSL Behring Full time

CSL Behring is a global biotechnology leader, guided by a promise to save and improve lives. Millions of people around the world are living with rare and serious medical conditions. CSL Behring is committed to delivering medicines that improve their lives.

With operations in 35+ nations and ~ 30,000 employees worldwide, CSL is inspired to develop and deliver a broad range of lifesaving therapies to treat disorders such as hemophilia and primary immune deficiencies, and vaccines to prevent influenza. Our therapies are also used in cardiac surgery, organ transplantation and burn treatment. CSL is the parent company of CSL Behring, CSL Plasma, CSL Seqirus and CSL Vifor. CSL Behring is a global leader in the protein biotherapeutics industry, focused on bringing to market biotherapies used to treat serious and often rare conditions.

Could you be our next Senior Statistical Programmer The job is located in the King of Prussia office. This is a hybrid position. You will report to the Associate Director of Statistical Programming.

You will provide hands-on support and technical guidance on clinical study teams. You will develop study and ad hoc output including: ADaM datasets, tables, figures and listings output and QC of requested output is the main focus of this role. You will work with the study statistician will be responsible for review and acceptance of contract research organization (CRO) deliverables which are datasets in submission ready standard format (ADaM), tables, figures and listings and submission packages. You will participate in the design and quality control process for SAS programs used to access, extract, transform, review and submit clinical data for all requested analyses. You will partner with other departments (eg, Biostatistics, Data Management, Regulatory Operations, Medical Writing, ESP teams) to ensure Standard Operating Procedures are followed and the correct study data are used for all requests. You will participate in department and technology development and process improvement programs

Responsibilities:

  • Collaborate with peers and statisticians to ensure the quality and accuracy –thus submission readiness –of clinical data by authorities (i.e. SDTM, ADaM, tables, figures, listings, and define.xml).

  • Lead requested efforts for pooled and exploratory analyses working with clinical programming team and their collection of legacy data.

  • Lead the in-house specification and delivery of ISS and ISE datasets and associated output (tables, figures, and listings) when not provided by CRO.

  • Lead the design and implementation of complex SAS programs for applications designed to report complex clinical trial data in CDISC ADaM format.

  • Identify problems and develop global tools that increase the efficiency and capacity of the Statistical Programming group.

  • Perform additional statistical analyses including: support responses to regulatory agencies, create integrated summary of safety and efficacy, support publications and presentations, support reporting of clinical trials with exploratory analyses of available data, replicate CRO and CSL statistician analyses for QC

Qualifications:

  • Bachelor's degree Computer Science, Mathematics, Statistics

  • At least 5 years of experience in either clinical programming and/or statisticalprogramming, within the CRO/pharmaceutical environment using SASSoftware.

  • Understanding of clinical programming and statistical programmingprocesses and standards.

  • Experiences with statistical programming using the SAS software includingdevelopment and use of SAS Macros.

  • Knowledge in CDISC standards (CDASH, SDTM, ADaM).

BENEFITS

Medical, Dental Vision

401K

Paid time Off

#LI-HYBRID

Our Benefits

CSL employees that work at least 30 hours per week are eligible for benefits effective day 1. We are committed to the wellbeing of our employees and their loved ones. CSL offers resources and benefits, from health care to financial protection, so you can focus on doing work that matters. Our benefits are designed to support the needs of our employees at every stage of their life. Whether you are considering starting a family, need help paying for emergency back up care or summer camp, looking for mental health resources, planning for your financial future, or supporting your favorite charity with a matching contribution, CSL has many benefits to help achieve your goals.

Please take the time to review our benefits site to see what’s available to you as a CSL employee.

About CSL Behring

CSL Behring is a global leader in developing and delivering high-quality medicines that treat people with rare and serious diseases. Our treatments offer promise for people in more than 100 countries living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. Learn more about CSL Behring.

We want CSL to reflect the world around us

As a global organization with employees in 35+ countries, CSL embraces diversity and inclusion. Learn more about Diversity & Inclusion at CSL.

Do work that matters at CSL Behring

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