Principal, Statistical Programmer​

Job description

CSL's R&D organization is accelerating innovation to deliver greater impact for patients.

With a project-led structure and a focus on collaboration, we’re building a future-ready team that thrives in dynamic biotech ecosystems.

Joining CSL now means being part of an agile team committed to developing therapies that make a meaningful difference worldwide.

Could you be our next Principal, Statistical Programmer?

The job is in our Waltham MA office.

This is a hybrid position and is onsite three days a week.

You will be a member of the Biostatistics team and plays a lead role in performing all statistical programming tasks required for clinical trial analysis and reporting.

This position works closely with other
members of the BDPM on various clinical projects.

During clinical trial from start up to the end of the clinical data analysis/report, the incumbent will be responsible for planning, preparing, managing, coordinating and performing
programming activities Is accountable oversee that applicable SEQ SOP and standards are implemented.

Provide technical expertise for regulatory submission relevant to statistical programming deliverables.

Support the function
director on managing and facilitating timelines and resource for the statistical programming group.

This role has global responsibilities with potential for matrix management, and participation in global teams.

**Main Responsibilities:**


1.

Provide statistical programming expertise in statistical programming
deliverables, including data processing, CDISC compliance, regulatory
submission and SAS coding.


2.

Help function director manage resources, timelines, and assignments for a
single or multiple clinical trials assigned to him/her.

Estimate resource
needs.

Work closely with the function director on resource allocation,
timeline consolidation and implementation.

3.

Oversee the work of statistical programming services provided by vendors to
achieve quality, timely, and cost-effective study deliverables.

Act as the
primary point of contact on all statistical programming matters with external
vendors that provide statistical programming services to Seqirus.


4.

Mentor junior programmers for their statistical programming activities.
Provide technical support and mentoring to junior programmers.


5.

Support development and maintenance of the Seqirus statistical
programming relevant standards, SOPs/WI and guidance.


6.

Perform statistical programming on various tasks for clinical data analysis
needs, including but not limited to generating Study Data Standardization
Plan (SDSP), SDTM data/ADaM data specifications, CRF annotation for
SDTM, define.xml, reviewers guide, system and study level macros, tables,
listings and figures, regulatory e-submission components.


7.

As a SME, establish and implement programming standards and comply with
regulatory requirements among project team members and across all
studies.

Develop standard macros and/or tools for the statistical
programming platform for data analysis and reporting.

Ensure that statistical
programs developed for specific protocols are effectively portable to other
protocols (Reusable code).


**Qualifications and Experience Requirements:**

Bachelor's Degree life science, computer programming, statistics etc.
5+ years of experience in scientific programming/simulations
Expertise in R or Python, and knowledge of SAS
Knowledge of GIT, or similar version control system
Experience in working with larger data sets (>1m records)
Ability to understand statistical issues, extract specifications, and convert into working simulation code

#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 (https://www.cslbenefits.com/csl/candidates) to see what’s available to you as a CSL employee.

**About CSL Behring**

CSL Behring (http://cslbehring.com/) is a global biotherapeutics leader driven by our promise to save lives.

Focused on serving patients’ needs by using the latest technologies, we discover, develop and deliver innovative therapies for people living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas.

We use three strategic scientific platforms of plasma fractionation, recombinant protein technology, and cell and gene therapy to support continued innovation and continually refine ways in which products can address unmet medical needs and help patients lead full lives.

CSL Behring operates one of the world’s largest plasma collection networks, CSL Plasma (http://www.cslplasma.com) .

Our parent company, CSL (https://www.csl.com/) , headquartered in Melbourne, Australia, employs 32,000 people, and delivers its lifesaving therapies to people in more than 100 countries.


**We want CSL to reflect the world around us**

At CSL, Inclusion and Belonging is at the core of our mission and who we are.

It fuels our innovation day in and day out.

By celebrating our differences and creating a culture of curiosity and empathy, we are able to better understand and connect with our patients and donors, foster strong relationships with our stakeholders, and sustain a diverse workforce that will move our company and industry into the future.

Learn more Inclusion and Belonging | CSL (https://www.csl.com/careers/inclusion-and-belonging) .

**Do work that matters at CSL Behring!**

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CSL makes all employment decisions without regard to race, color, religion, national origin, ancestry, age, sex, gender, pregnancy, disability, marital status, sexual orientation, gender identity, genetic information, military status, protected veteran status (specifically status as a disabled veteran, recently separated veteran, armed forces service medal veteran, or active duty wartime or campaign badge veteran) or other classification protected by applicable US federal, state or local law.

CSL complies with all applicable employment laws, including but not limited to Title VII of the Civil Rights Act of 1964, the Americans with Disabilities Act, the Fair Labor Standards Act, and the Immigration Reform and Control Act.

https://www.cslbehring.com/careers/eeo-statement

Required Skill Profession

Other General