Senior Manager, Principal Statistical Programmer, Biometrics

Society for Conservation Biology; Town of Texas (WI); Remote; USD 127,000 - 191,000; Full time

Job summary

A leading biopharmaceutical company is seeking a Principal Statistical Programmer to join their Biometrics team. The role involves developing programming specifications, ensuring compliance with CDISC standards, and providing technical guidance in SAS programming. The ideal candidate will have extensive experience in the biopharmaceutical industry and a strong background in statistical programming.

Benefits

Premium benefits package

Competitive performance-based compensation

Commitment to diversity

Psychological safety

Deliberate Development

Qualifications

• 7+ years biopharmaceutical industry experience.
• 3+ years project management experience as a statistical programmer.
• Hands-on experience on SDTM mapping from various data sources.

Responsibilities

• Responsible for study-level statistical programming deliverables.
• Develop or validate programming specifications and programs.
• Ensure compliance with regulatory requirements and Agios standards.

Skills

SAS/Base

SAS/Macro

SAS/STAT

SAS/Graph

SAS/SQL

Statistical programming

Project management

Clinical database design

Real World Data

Education

MS or equivalent degree

Job description

Senior Manager, Principal Statistical Programmer, Biometrics

Who we are:

Agios is a biopharmaceutical company that is fueled by connections. We thrive in a supportive, fun, and flexible environment full of people empowered to bring their whole selves to work. We care deeply about our work, each other, and the patients who count on us. Our teams cultivate strong bonds with patient communities, healthcare professionals, partners and colleagues, which helps us discover, develop and deliver therapies for rare diseases - and make a bigger difference in their lives. In the U.S., Agios markets a first-in-class pyruvate kinase (PK) activator for the treatment of hemolytic anemia in adults with PK deficiency. Building on the company's leadership in the field of cellular metabolism, Agios is advancing a robust clinical pipeline of investigational medicines with active and planned programs in alpha- and beta-thalassemia, sickle cell disease, pediatric PK deficiency and MDS-associated anemia.

The impact you will make:

Agios Pharmaceuticals is searching for a dynamic Principal Statistical Programmer to join our growing Biometrics team. We want someone who cares about this important work, and who's driven to connect to our mission of helping these patient communities. The Principal Statistical Programmer will be responsible for study-level statistical programming deliverables including development of programming specifications and programs to generate SDTMs and analysis datasets using Agios or CDISC standards or study-specific/submission-specific requirements, review of CRFs and creation of SDTM-annotated CRFs, review of statistical analyses plans, analyses data sets, and outputs, hands-on statistical programming activities, and review of deliverables from CROs. The successful candidate must have working-knowledge of CDISC requirements and Pinnacle 21.

What you will do:

• Provides technical and project management guidance in SAS programs and applications designed to analyze and report clinical trial data and for electronic submissions of data in CDlSC format.
• Develop or validate programming specifications and programs to generate SDTMs and analysis datasets, using Agios or CDISC standards or study-specific/submission-specific requirements.
• Develop or validate specifications and programs to generate tables, listings, and figures based on Agios standards or study-specific/submission-specific requirements.
• Create SDTM-annotated CRFs
• Accountable for study-level statistical programming deliverables on assigned projects, including timeliness and quality of deliverables.
• Review statistical analyses plans and case report forms.
• Ensure documentation is maintained to the standard required according to CDISC-compliant submissions and is acceptable for audit.
• Help establish and maintain statistical programming standards at Agios.
• Ensure that all study-level statistical programming activities are conducted in compliance with relevant regulatory requirements, Agios SOPs and Agios standards.
• Serve as a general statistical programming resource at Agios including representation in cross-functional teams working on standard operating procedures, guidelines, process improvements, system validation and acquisition, customization, and integration of new tools and technologies.

What you bring:

• MS or equivalent degree with:
• 7+ years biopharmaceutical industry experience
• 3+ years project management experience as a statistical programmer
• Advanced knowledge of SAS/Base, SAS/Macro, SAS/STAT, SAS/Graph, and SAS/SQL in a windows environment
• Extensive experience and proven skills in the use of SAS within a Statistical Programming environment to develop and validate analysis datasets, tables, listings, and figures
• Hands-on experience on SDTM mapping from various data sources
• Knowledge of clinical database design, specifically electronic data capture using Rave, Veeva, and Medidata
• Experience supporting electronic submissions in the eCTD format
• Excellent oral and written communication skills
• Experience with Real World Data a plus

Concerned that you don't check off every box in the requirements listed above? Please apply anyway! At Agios, we value each other's differences and recognize that teams thrive when everyone brings their unique experiences to the table. We are dedicated to building an inclusive, diverse, equitable, and accessible environment where all employees can bring their whole selves to work. If you're excited about this role but your previous experience doesn't align perfectly with the job description, we still encourage you to apply. You may be just the right candidate for this role or another opening!

Work Location:

Location Agnostic: Work location for this role is based on employees individual preference. This role has the ability to be either remote in the US or hybrid in our Cambridge Headquarters. Hybrid schedules vary but are generally less than 3 days per week onsite and hybrid employees are expected to live within commutable distance to our Cambridge Headquarters. Remote employees work entirely from home except for attending Company sponsored events/ meetings. For employees who choose to work remotely, travel may be required for certain company events commensurate to the above job description..

What we will give you:

• Deliberate Development. Your professional growth as one of our top priorities.
• We're all about individual needs. We embrace different perspectives, work styles, health and wellness approaches, care of families and productivity. When you're at your best, we're at our best.
• Premium benefits package. We invest in the health, wellbeing, and security of our people with a premium benefits package that is well-rounded and flexible to help meet the varied personal and professional needs of every member of our team.
• Competitive and equitable performance-based compensation. This includes base salary and both short- and long-term incentives that are connected to our business strategy and vary based on individual and company performance.
• The current base salary range for this position is expected to be between $127,219 and $190,828 annualized; final salary will be determined based on various factors including, but not limited to, years of relevant experience, job knowledge, skills and proficiency, degree/education, and internal comparators.
• Competitive performance-based compensation. This includes both short- and long-term incentives that are connected to our business strategy.
• Psychological safety. We support an environment of fearlessness. We want you to share your ideas, speak candidly and take data-informed risks to help push the boundaries.
• Commitment to diversity. We strive to foster a welcoming workplace where everyone can thrive. We're continuously looking to improve the inclusivity of our workforce.
• Commitment to community. We're an active participant in the communities that surround us - the communities where we live, and the community of people and their loved ones in need of better treatment options for conditions that are often overlooked.

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