Director, Statistical Programming Technical Solutions Summary of Key Responsibilities Designs and leads Quantitative Sciences data and analytics systems strategy and/or technical development initiatives including systems…
Skills: Statistical programming, AWS cloud platform, Data analytics, Clinical development, Systems integration
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$201k–$272k/yr
Full-time
bachelor degree, postgraduate degree
Medical coverage, Dental coverage, Vision coverage, Life insurance, Disability insurance, Lifestyle reimbursement program
Posted 16h ago
~40 hrs/week
Responsibilities
The Director leads the strategic vision and technical development of data and analytics systems to support statistical programming and clinical development functions. They oversee the deployment of AWS-hosted environments, ensure regulatory compliance, and drive innovation through the integration of advanced analytics and generative AI.
Requirements
Candidates must have at least 15 years of industry experience in pharmaceutical, biotech, or CRO environments with a strong background in clinical data systems and AWS. A bachelor's degree in computer science, statistics, mathematics, or information sciences is required, along with advanced knowledge of GCP/ICH standards and regulatory validation requirements.
Designs and leads Quantitative Sciences data and analytics systems strategy and/or technical development initiatives including systems and technology integration, data sharing, analysis, transfer/access and storage platforms or utilities.
Establishes Quantitative Sciences technical direction, standards, and governance policies for analytical solutions and platforms, as well as best practices for efficient and inspection ready delivery across the data flow.
Lead the strategic vision, implementation, and continuous evolution of the AWS cloud platform supporting Statistical Programming, Biostatistics, Epidemiology, Data Science, and Clinical Development functions.
Oversee the design, deployment, validation, and lifecycle management of AWS-hosted programming and analytics environments within regulated GxP settings.
Promotes technical innovation to drive the development of data, analysis and visualization solutions within a clinical data environment.
Develop strategies in collaboration with Data Science team for integrating generative AI and other advanced analytics tools into statistical programming workflows while ensuring regulatory compliance and appropriate validation.
Leads technical assessments of vendor products or new technologies; manages and establishes relationships with technical vendors to support business needs.
Collaborates with Clinical Development Operations, IT and other functional leaders to ensure organizational effectiveness / efficiencies from systems and technology platforms.
Partners with the IT Validation / QA organizations to ensure compliance of clinical data systems and processes to regulatory requirements.
Collaborates with IT on technical project prioritization, forecasting, estimation, and budgeting.
Facilitates change management activities and training for key systems and processes.
Qualifications
Minimum 15 years’ industry experience (Pharmaceutical, Biotech, CRO) leading technical projects and/or supervising teams to deliver data/analytics solutions;
Demonstrated technical expertise with clinical databases, AWS/EDC platforms, data imports/integrations, data analytics platforms and/or data visualization tools; advanced programming and analytical skills using SAS, R and Python an asset.
Experience driving data solutions projects or system implementations (i.e., data dashboards, R/SAS/data analytics infrastructure, data warehousing, data visualization and/or risk-based data review tools/systems) with clinical team members;
Demonstrated experience working with IT and cross-functional counterparts in evaluating and implementing clinical data systems, constructing technical business requirements, specifications and supporting validation documentation
Experience managing technical teams (FTEs, Functional Service Providers or vendors);
Demonstrated leadership in implementing solutions within the clinical data flow, understanding of CDISC standards, and technologies/utilities in support of Quantitative Sciences data flow (from CRF to CSR);
Detailed knowledge of data management, statistical programming environments, processes, procedures, and roles;
Detailed knowledge of data management, statistical programming environments, processes, procedures, and roles;
Experience developing SOPs, Standards or implementing technical best practices;
Experience overseeing vendors in the delivery of technical solutions, including development of quality and performance metrics;
Excellent written and oral presentation and interpersonal, organizational, analytical, project management and multi-tasking skills;
Advanced knowledge of GCP/ICH standards, 21 CFR Part 11, Validation requirements;
Bachelor’s Degree required in areas of computer science, statistics, mathematics or information sciences, MBA, advanced degree and / or Project Management certification preferred
Clear alignment with Alnylam Core Values:
Commitment to People
Innovation and Discovery
Sense of Urgency
Open Culture
Passion for Excellence
#LI-AB1 #LI-Hybrid
Alnylam Pharmaceuticals is an EEO employer committed to an exciting, diverse, and enriching work environment.
U.S. Pay Range
$200,700.00 - $271,500.00
The pay range reflects the full-time base salary range we expect to pay for this role at the time of posting. Base pay will be determined based on a number of factors including, but not limited to, relevant experience, skills, and education. This role is eligible for an annual short-term incentive award (e.g., bonus or sales incentive) and an annual long-term incentive award (e.g., equity).
Alnylam’s robust Total Rewards package is designed to support your overall health and well-being. We offer comprehensive benefits including medical, dental, and vision coverage, life and disability insurance, a lifestyle reimbursement program, flexible spending and health savings accounts and a 401(k)with a generous company match. Eligible employees enjoy paid time off, wellness days, holidays, and two company-wide recharge breaks. We also offer generous family resources and leave. Our commitment to your well-being reflects our belief that caring for our people fuels the impact we create together.
Learn more about these and additional benefits offered by Alnylam by visiting the Benefits section of the Careers website: https://www.alnylam.com/careers
About Alnylam
We are the leader in RNAi therapeutics – a revolutionary approach with the potential to transform the lives of people with rare and common diseases. Built on Nobel Prize-winning science, Alnylam has delivered the breakthroughs that made RNAi therapeutics possible and are just at the beginning of what’s possible. Our deep pipeline, late-stage programs, and bold vision reflect our core values: fierce innovation, passion for excellence, purposeful urgency, open culture and commitment to people. We're proud to be a globally recognized top employer, where an authentic, inclusive culture and breakthrough thinking fuel one another.
At Alnylam, we commit to an inclusive recruitment process and equal employment opportunity. Qualified applicants will receive consideration for employment without regard to their sex, gender or gender identity, sexual orientation, race, color, ethnicity, national origin, ancestry, citizenship, religion, creed, physical or mental disability, pregnancy status or related conditions, genetic information, veteran or military status, marital or familial status, political affiliation, age, or any other factor protected by federal, state, or local law. Alnylam is an E-Verify Employer.
Alnylam is the leading RNAi therapeutics company. We're a fast-growing biopharma with a deep pipeline and global reach.
Industry
Biotechnology Research
Company size
1,001-5,000 employees
Founded
2002
Headquarters
Cambridge, Massachusetts
LinkedIn followers
294,821
Total funding
$4.5B
SILENCE DISEASE. AMPLIFY LIFE.™
Alnylam is a leading independent biopharmaceutical company and the pioneer in RNA interference (RNAi) therapeutics – a revolutionary approach to treating diseases which “silences” the genes that cause or contribute to them.
Founded in 2002 by a group of distinguished researchers and biotech leaders, Alnylam’s work over more than two decades has yielded the critical breakthroughs and advancements that have made the field of (RNAi) therapeutics possible. In 2018, our first commercial medicine, and the world’s first RNAi therapeutic was approved. Since then, five more Alnylam-developed medicines have been approved and we’re hard at work developing new therapies to treat both rare and prevalent diseases.
We are a global and diverse company of 2,600+ people. We pride ourselves on fostering a fun, inclusive and dynamic work environment where employees can recognize their fullest potential. That's why we’re consistently ranked as a top employer by The Boston Globe (2015-25), Science Magazine (2018-25), Fast Company (Best Workplaces for Innovators 2020-25) and Great Place to Work.
We are based in Cambridge, Massachusetts (U.S.), with offices throughout North America, Europe, Asia, and South America.
See our social media community guidelines: https://bit.ly/2FcRhJy.
Please note: If you wish to report an adverse event or product complaint, please email [email protected] or you may call us using the following telephone numbers: for North America, 877.ALNYLAM (877.256.9526), for Europe, +31 20 369 7861
Fraudulent Recruitment Activity
Be aware of the potential for scams and fraudulent recruitment activity from individuals claiming to represent Alnylam Pharmaceuticals. Alnylam never conducts its interview process via messaging apps, freelance sites, or social media platforms. Alnylam team members only communicate with potential candidates through an official Alnylam email address ending in "@alnylam.com."
Offices: 675 W Kendall St, Cambridge, Massachusetts 02142, US · 27 Market Street, Maidenhead, England SL6 8AA, GB · Grafenauweg 4, Zug, Zug 6300, CH · Antonio Vivaldistraat 150, Amsterdam, North Holland 1083, NL · Erika-Mann-Str. 7, Munich, Bavaria 80636, DE
Alnylam is the leading RNAi therapeutics company. We're a fast-growing biopharma with a deep pipeline and global reach.
Industry
Biotechnology Research
Company size
1,001-5,000 employees
Founded
2002
Headquarters
Cambridge, Massachusetts
LinkedIn followers
294,821
Total funding
$4.5B
SILENCE DISEASE. AMPLIFY LIFE.™
Alnylam is a leading independent biopharmaceutical company and the pioneer in RNA interference (RNAi) therapeutics – a revolutionary approach to treating diseases which “silences” the genes that cause or contribute to them.
Founded in 2002 by a group of distinguished researchers and biotech leaders, Alnylam’s work over more than two decades has yielded the critical breakthroughs and advancements that have made the field of (RNAi) therapeutics possible. In 2018, our first commercial medicine, and the world’s first RNAi therapeutic was approved. Since then, five more Alnylam-developed medicines have been approved and we’re hard at work developing new therapies to treat both rare and prevalent diseases.
We are a global and diverse company of 2,600+ people. We pride ourselves on fostering a fun, inclusive and dynamic work environment where employees can recognize their fullest potential. That's why we’re consistently ranked as a top employer by The Boston Globe (2015-25), Science Magazine (2018-25), Fast Company (Best Workplaces for Innovators 2020-25) and Great Place to Work.
We are based in Cambridge, Massachusetts (U.S.), with offices throughout North America, Europe, Asia, and South America.
See our social media community guidelines: https://bit.ly/2FcRhJy.
Please note: If you wish to report an adverse event or product complaint, please email [email protected] or you may call us using the following telephone numbers: for North America, 877.ALNYLAM (877.256.9526), for Europe, +31 20 369 7861
Fraudulent Recruitment Activity
Be aware of the potential for scams and fraudulent recruitment activity from individuals claiming to represent Alnylam Pharmaceuticals. Alnylam never conducts its interview process via messaging apps, freelance sites, or social media platforms. Alnylam team members only communicate with potential candidates through an official Alnylam email address ending in "@alnylam.com."
Offices: 675 W Kendall St, Cambridge, Massachusetts 02142, US · 27 Market Street, Maidenhead, England SL6 8AA, GB · Grafenauweg 4, Zug, Zug 6300, CH · Antonio Vivaldistraat 150, Amsterdam, North Holland 1083, NL · Erika-Mann-Str. 7, Munich, Bavaria 80636, DE